Comparative Study of Efficacy of Combined Behavioural Therapy and Glycopyrrolate Versus Glycopyrrolate Alone in The Treatment of Sialorrhea in Children With Neurodevelopmental Disabilities: Randomized controlled Trial - GLYCOB

Start Date15 May 2024

Sponsor / Collaborator-

NCT06376942 / Not yet recruitingPhase 2/3IIT

A Randomized, Double-blind, Placebo-controlled Trial to Compare the Effectiveness of Nebulized Anticholinergics for Cough Suppression During Flexible Bronchoscopy

No study has examined the role of inhaled glycopyrrolate on mucus secretion. We hypothesize that nebulized glycopyrrolate will improve bronchoscopy procedure by effectively suppressing airway mucus secretion, thereby decreasing cough, and thus improving patient comfort during bronchoscopy. In this study, we aim to compare the efficacy of nebulized glycopyrrolate versus nebulized ipratropium in suppression of cough during flexible bronchoscopy.

Start Date24 Apr 2024

Sponsor / Collaborator

Post Graduate Institute of Medical Education & Research

CTRI/2024/03/064392 / Not yet recruitingPhase 4

Comparative study of Sugammadex with Neostigmine and Glycopyrolate as a reversal agent in Laparoscopic Cholecystectomy - NIL

Start Date29 Mar 2024

Sponsor / Collaborator-

100 Clinical Results associated with Glycopyrrolate

100 Translational Medicine associated with Glycopyrrolate

100 Patents (Medical) associated with Glycopyrrolate

1,736

Literatures (Medical) associated with Glycopyrrolate

01 May 2024·Journal of clinical anesthesia

Post-operative urinary retention is impacted by neuromuscular block reversal agent choice: A retrospective cohort study in US hospital setting

Article

Author: Turzhitsky, Vladimir ; Weingarten, Toby N ; Mark, Robert J ; Bash, Lori D ; Hofer, Ira S

STUDY OBJECTIVE:

Perioperative neuromuscular blocking agents are pharmacologically reversed to minimize complications associated with residual neuromuscular block. Neuromuscular block reversal with anticholinesterases (e.g., neostigmine) require coadministration of an anticholinergic agent (e.g., glycopyrrolate) to mitigate muscarinic activity; however, sugammadex, devoid of cholinergic activity, does not require anticholinergic coadministration. Single-institution studies have found decreased incidence of post-operative urinary retention associated with sugammadex reversal. This study used a multicenter database to better understand the association between neuromuscular block reversal technique and post-operative urinary retention.

DESIGN:

Retrospective cohort study utilizing large healthcare database.

SETTING:

Non-profit, non-governmental and community and teaching hospitals and health systems from rural and urban areas.

PATIENTS:

61,898 matched adult inpatients and 95,500 matched adult outpatients.

INTERVENTIONS:

Neuromuscular block reversal with sugammadex or neostigmine plus glycopyrrolate.

MEASUREMENTS:

Incidence of post-operative urinary retention by neuromuscular block reversal agent and the independent association of neuromuscular block reversal technique and risk of post-operative urinary retention.

MAIN RESULTS:

The incidence of post-operative urinary retention was 2-fold greater among neostigmine with glycopyrrolate compared to sugammadex patients (5.0% vs 2.4% inpatients; 0.9% vs 0.4% outpatients; both p < 0.0001). Multivariable logistic regression identified reversal with neostigmine to be independently associated with greater risk of post-operative urinary retention (inpatients: odds ratio, 2.20; 95% confidence interval, 2.00 to 2.41; p < 0.001; outpatients: odds ratio, 2.57; 95% confidence interval, 2.13 to 3.10; p < 0.001). Post-operative urinary retention-related visits within 2 days following discharge were five-fold higher among those reversed with neostigmine than sugammadex among inpatients (0.05% vs. 0.01%, respectively; p = 0.018) and outpatients (0.5% vs. 0.1%; p < 0.0001).

CONCLUSION:

Though this study suggests that neuromuscular block reversal with neostigmine can increase post-operative urinary retention risk, additional studies are needed to fully understand the association.

01 Feb 2024·The Journal of pediatrics

Comparative Efficacy and Side Effect Profiles of Interventions for Pediatric Saliva Control: A Cohort Study

Article

Author: Fairhurst, Charlie ; Absoud, Michael ; Mahony, Aoife ; Papandreou, Apostolos ; Breaks, Anne

OBJECTIVE:

To compare efficacy and side effect profile data on conservative, behavioral, pharmacological, and surgical treatments used for pediatric saliva control.

STUDY DESIGN:

A cohort study of children (n = 483) referred to a specialty Saliva Control service between May 2014 and November 2019 was performed, using quantitative data from pretreatment and post-treatment questionnaires (the Drooling Impact Scale [DIS], Drooling Rating Scale [DRS]) and recording of side effects. Overall, 483 children were included; treatment choices were based on published international guidelines.

RESULTS:

The greatest improvement was seen after intraglandular botulinum toxin A (BTX-A) injections (n = 207; 551 courses; mean DIS change, 34.7; 95% CI = 29.2-35.7) or duct transpositional surgery (n = 31; mean change in DIS, 29.0; 95% CI, 22.3-35.7). Oral anticholinergics were associated with good outcomes, with no significant statistical difference between glycopyrronium bromide (n = 150; mean DIS change, 21.5; 95% CI, 19.1-24.0) or trihexyphenidyl (n = 87; mean DIS change, 22.4; 95% CI, 18.9-25.8). Inhaled ipratropium bromide was not as efficacious (n = 80; mean DIS change, 11.1; 95% CI, 8.9-13.3). Oromotor programs were used in a selected group with reliable outcomes (n = 9; mean DIS change, 13.0). Side effects were consistent with previous studies. Overall, in cases of milder severity, enterally administered therapies provided a good first-line option. With more severe problems, BTX-A injections or saliva duct transpositional surgery were more effective and well tolerated.

CONCLUSIONS:

We describe a large, single-center pediatric saliva control cohort, providing direct comparison of the efficacy and side effect profiles for all available interventions and inform clinical practice for specialists when considering different options. BTX-A injections or saliva duct transpositional surgery seem to be more effective for saliva control that is more severe.

01 Feb 2024·International journal of pharmaceutics

Mixing energy as an adjustment tool for aerodynamic behaviour of an inhaled product: In-vitro and in-vivo effects

Article

Author: Göransson, Stefan ; Lyberg, Ann-Marie ; Matilainen, Laura ; Husman-Piirainen, Johanna ; Kirjavainen, Merja ; Heinonen, Elina ; Autio, Maiju ; Lähelmä, Satu ; Eriksson, Patrik ; Thalberg, Kyrre

This paper describes the development of a fixed dose dry powder combination of indacaterol maleate (Inda) and glycopyrronium bromide (Glyco) in Easyhaler® inhaler for a comparative pharmacokinetic (PK) study, as well as the outcome of such a study. The development aim was to produce formulations with three different in vitro dispersibility profiles for both Inda and Glyco. This so-called 'rake' approach allows for quantitation of the candidate formulations relative to the reference product Ultibro® Breezhaler® in terms of the key PK parameters. Three formulations (A, B and C) were produced based on the mixing energy concept. For both APIs, formulation A (lowest mixing energy) displayed the highest fine particle fractions and formulation C (highest mixing energy) the lowest. GMP manufacturing confirmed the performance of the three formulations. The candidate formulations were tested against the reference product in a single dose PK study in healthy volunteers. Clear differences in Inda plasma concentration profiles were observed between the treatments when administered concomitantly with charcoal, with Easyhaler A showing the highest C_max value and Easyhaler C the lowest. Easyhaler B was bioequivalent to Ultibro Breezhaler with regard to the primary PK parameters of Inda, C_max and AUC_72h. For Glyco, Easyhaler formulations A, B and C provided lower peak concentrations than Ultibro Breezhaler. For AUC_72h of Glyco_, Easyhaler B was bioequivalent to the reference product. Additional measures for adjustment of formulation performance can be foreseen, whose effects can be predicted based on mixing energy theory.

News (Medical) associated with Glycopyrrolate

20 Jun 2024

·www.fiercepharma.com

No sweat for dermatology specialist Botanix as hyperhidrosis gel Sofdra gains FDA approval

Hyperhidrosis is the third largest dermatology market behind acne and atopic dermatitis, according to Botanix. Everybody sweats, but for the 10 million people in the U.S. living with primary axillary hyperhidrosis, sweating can take on a whole new meaning. The condition is hallmarked by sweating beyond the level necessary to regulate body temperature. Primary axillary hyperhidrosis specifically refers to the underarms and has major effects on quality of life, potentially impacting patients' work productivity, social interactions and emotional well-being. It’s been years since a new treatment hit the market in this condition. With an FDA approval in hand, Botanix hopes its topical gel Sofdra can change the game. The drug won FDA approval to treat primary axillary hyperhidrosis in patients ages 9 and older. It’s the first and only new chemical entity cleared for the condition, Botanix said in a press release. Current treatment options include AbbVie’s Botox injections and different formulations of glycopyrrolate. Many of the marketed therapies aren’t as targeted as Sofdra so they can dry out other fluids, such as tears, saliva and even cause urinary retention, Botanix’s founder and board executive director, Matt Callahan, said in a recent interview. In two phase 3 studies that enrolled a total of 701 patients, the gel helped patients achieve clinically and statistically meaningful improvements from baseline levels in the Gravimetric Sweat Production scale and the Hyperhidrosis Disease Severity Measure-Axillary score, according to the company's release. Reaching the roughly 10 million U.S. patients with primary axillary hyperhidrosis will require a unique commercial approach for Botanix, especially considering that fewer than half of patients have an official diagnosis, according to the company. Bearing in mind the social challenges the condition presents, many patients may be actively searching online to find a treatment, as opposed to visiting the dermatologist’s office, Callahan said. Botanix will reach these patients through a “very strong digital approach” that includes a telemedicine component. “This is kind of one of those areas where people don't like to talk about it much and dermatologists don't seem to know much about it,” Callahan explained. “So we're trying to solve that problem with a telemedicine approach to provide a better service and a better fulfillment option to these patients.” Still, the large patient population makes for a “massive opportunity” for Botanix, the executive said. Sofrda is the Australia-based company’s first commercial product. It will come with a price tag “on par” with other treatments on the market, but the key difference, Callahan said. Prescription wipe Qbrexza has an average retail price of $771, according to GoodRx. Considering 90% of those with hyperhidrosis also suffer from excessive sweating in other areas of the body, there is “lots of future potential” from a label expansion perspective, Callahan noted. Callahan says Botanix is something of a “hidden gem” on the Australian Stock Exchange, but the drugmaker plans to become “the next big dermatology company in the U.S.," he added. Its U.S. operations are based in Pennsylvania and Arizona, and the company is also working on treatments for acne and rosacea. The approval makes for a “transformative event” for the company as it transitions “from a development stage to a revenue-generating dermatology company,” CEO Howie McKibbon, M.D., added in Botanix's release. The drugmaker will roll out initial doses through an early patient experience program during this year’s third quarter. The wider launch is expected to take off during the fourth quarter.

Phase 3Drug ApprovalClinical Result

09 May 2024

·www.globenewswire.com

Verona Pharma Announces $650 Million Strategic Financing with Oaktree and OMERS

Non-dilutive funding will support planned US commercial launch and expansion of ensifentrine’s clinical activities Cash runway extended beyond 2026 LONDON and RALEIGH, N.C., May 09, 2024 (GLOBE NEWSWIRE) -- Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma”), announces it and its wholly-owned subsidiary, Verona Pharma, Inc. (“VPI” and together with Verona Pharma, the “Company”), have entered into strategic financing agreements providing access to up to $650 million from funds managed by Oaktree Capital Management, L.P. (“Oaktree”) and OMERS Life Sciences (“OMERS”). The agreements provide non-dilutive capital and additional financial flexibility ahead of Verona Pharma’s planned US launch of ensifentrine and will support the Company’s continued growth. Ensifentrine is currently under review by the US Food and Drug Administration (“FDA”), and, if approved, is expected to be the first novel inhaled mechanism for the maintenance treatment of chronic obstructive pulmonary disease in more than 20 years. The strategic financing was led by Oaktree and is comprised of the following: Debt facility: Up to $400 million in term loans available in five separate tranches via a term loan facility (“debt facility”).Revenue interest purchase and sale agreement (“RIPSA”): Up to $250 million in funding from the sale of a redeemable interest in future ensifentrine-related revenue, which is capped at 1.75x of the amount funded. The debt facility replaces the existing facility of up to $400 million with funds managed by Oxford Finance LLC and Hercules Capital, Inc. (NYSE: HTGC). Under the terms of the debt facility, VPI is drawing $55 million at closing, and may draw, subject to certain conditions, an additional $70 million upon FDA approval of ensifentrine, $175 million in two separate tranches upon achievement of certain net sales milestones and, subject to the approval of the Lenders, $100 million to support strategic initiatives. VPI will pay only interest on the outstanding loans under the five-year debt facility on a quarterly basis with all amounts outstanding due at maturity. Approximately $52 million of the loans drawn at closing will be used to repay in full the existing facility, including to pay fees and associated costs thereunder. Under the terms of the RIPSA, VPI will receive $100 million upon FDA approval of ensifentrine and will be eligible to draw an additional $150 million upon the achievement of certain net sales milestones. The revenue interest financing rate is 5% and 6.5% of certain proceeds the Company receives from licensees that the Company may engage during the term of the RIPSA outside of the US and in the US, respectively, and 6.5% of global net sales of ensifentrine by the Company. The total revenue interest financing payable by the Company to Oaktree and OMERS is capped at 1.75x of the amount actually funded, with the ability to redeem the RIPSA at lower multiples within the first three years from funding. “As we finalize preparations for the potential US approval and commercial launch of ensifentrine, we are pleased to be working with Oaktree and OMERS who are aligned with our view of ensifentrine’s importance to the COPD community and its commercial opportunity. This strategic agreement, with access to up to $650 million, allows us to further strengthen our cash position and improve our financial flexibility,” said David Zaccardelli, Pharm. D., President and Chief Executive Officer of Verona Pharma. “These funds, together with our existing cash of $255 million, are expected to support the Company through commercialization and growth beyond 2026.” “We believe ensifentrine’s impressive clinical data generated to date and unique mechanism of action position it well to become a paradigm-shifting advancement in the maintenance treatment of COPD, a condition with continued unmet need,” said Aman Kumar, Co-Portfolio Manager for Oaktree’s Life Sciences Lending platform. “This strategic investment in Verona Pharma underscores Oaktree’s commitment to provide flexible capital solutions to innovative life sciences companies that are working on bringing important therapies to patients and providers worldwide.” Morgan Stanley & Co. LLC acted as sole structuring agent on the transaction. Latham & Watkins LLP served as legal counsel to Verona Pharma. Sullivan & Cromwell LLP served as legal counsel to Oaktree. For further information please contact: Verona Pharma plcUS Tel: +1-833-417-0262UK Tel: +44 (0)203 283 4200Victoria Stewart, Senior Director of Investor Relations and CommunicationsIR@veronapharma.comArgot PartnersUS Investor EnquiriesTel: +1-212-600-1902verona@argotpartners.comTen Bridge CommunicationsInternational / US Media EnquiriesTel: +1-312-523-5016tbcverona@tenbridgecommunications.comLeslie Humbel About Verona Pharma Verona Pharma is a biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of chronic respiratory diseases with significant unmet medical needs. In the third quarter of 2023, the US Food and Drug Administration accepted for review the Company’s NDA for ensifentrine for the maintenance treatment of patients with COPD and assigned a PDUFA target action date of June 26, 2024. If approved, ensifentrine has the potential to become the first inhaled non-steroidal therapy for the treatment of respiratory diseases that combines bronchodilator and anti-inflammatory activities in one molecule. The Company has evaluated nebulized ensifentrine in its Phase 3 clinical program ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) for COPD maintenance treatment. Ensifentrine met the primary endpoint in both ENHANCE-1 and ENHANCE-2 trials demonstrating statistically significant and clinically meaningful improvements in lung function. In addition, ensifentrine substantially reduced the rate and risk of COPD exacerbations in pooled analysis from ENHANCE-1 and ENHANCE-2. Two additional formulations of ensifentrine have been evaluated in Phase 2 trials for the treatment of COPD: dry powder inhaler (“DPI”) and pressurized metered-dose inhaler (“pMDI”); and a fixed-dose combination formulation with ensifentrine and glycopyrrolate, a LAMA, is currently under development, also for the treatment of COPD. Ensifentrine also has potential applications in cystic fibrosis, non-cystic fibrosis bronchiectasis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com. About Oaktree Oaktree is a leader among global investment managers specializing in alternative investments, with $192 billion in assets under management as of March 31, 2024. The firm emphasizes an opportunistic, value-oriented and risk-controlled approach to investments in credit, private equity, real assets and listed equities. The firm has over 1,200 employees and offices in 23 cities worldwide. For additional information, please visit Oaktree’s website at http://www.oaktreecapital.com/. About OMERS Life Sciences and OMERS OMERS Life Sciences provides royalty financings and other non-dilutive solutions to biopharma companies and academic institutions, supporting their efforts to address unmet medical needs and improve the quality of life of patients around the world. OMERS is a jointly sponsored, defined benefit pension plan, with 1,000 participating employers ranging from large cities to local agencies, and over 600,000 active, deferred and retired members. Our members include union and non-union employees of municipalities, school boards, local boards, transit systems, electrical utilities, emergency services and children’s aid societies across Ontario. OMERS teams work in Toronto, London, New York, Amsterdam, Luxembourg, Singapore, Sydney and other major cities across North America and Europe – serving members and employers, and originating and managing a diversified portfolio of high-quality investments in bonds, public and private credit, public and private equity, infrastructure and real estate. Forward-Looking Statements This press release contains forward-looking statements. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding the debt facility providing non-dilutive capital and further financial flexibility to support Verona Pharma’s continued growth, including the planned commercial launch of ensifentrine, statements regarding the future availability of future draws under the debt facility, the timing of repayment and termination of the existing facility, the ability of Verona Pharma to reach certain net sales milestones, the potential for ensifentrine to be the first therapy for the treatment of respiratory diseases to combine bronchodilator and non-steroidal anti-inflammatory benefits in one compound, the potential for ensifentrine to be the first novel inhaled mechanism for the maintenance treatment of chronic obstructive pulmonary disease in more than 20 years and the potential of ensifentrine in the treatment of cystic fibrosis, non-cystic fibrosis bronchiectasis, asthma and other respiratory diseases, as well as the potential of the DPI and pMDI formulations of ensifentrine. These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from our expectations expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history; our need for additional funding to complete development and commercialization of ensifentrine, which may not be available and which may force us to delay, reduce or eliminate our development or commercialization efforts; the reliance of our business on the success of ensifentrine, our only product candidate under development; economic, political, regulatory and other risks involved with international operations; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; serious adverse, undesirable or unacceptable side effects associated with ensifentrine, which could adversely affect our ability to develop or commercialize ensifentrine; we may not be successful in developing ensifentrine for multiple indications; our ability to obtain approval for and commercialize ensifentrine in multiple major pharmaceutical markets; misconduct or other improper activities by our employees, consultants, principal investigators, third-party service providers and licensees; our inability to realize the anticipated benefits under licenses granted by us to third parties to develop and commercialize ensifentrine, our future growth and ability to compete depends on retaining our key personnel and recruiting additional qualified personnel; material differences between our “top-line” data and final data; our reliance on third parties, including clinical research organizations, clinical investigators, manufacturers and suppliers, and the risks related to these parties’ ability to successfully develop and commercialize ensifentrine; lawsuits related to patents covering ensifentrine and the potential for our patents to be found invalid or unenforceable; lawsuits related to our licensing of patents and know-how with third parties for the development and commercialization of ensifentrine; changes in our tax rates, unavailability of certain tax credits or reliefs or exposure to additional tax liabilities or assessments could affect our profitability, and audits by tax authorities could result in additional tax payments for prior periods; and our vulnerability to natural disasters, global economic factors, geo-political actions and unexpected events, including health epidemics or pandemics, and conflicts such as the Russia-Ukraine conflict, which has and may continue to adversely impact our business. These and other important factors under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023, as updated in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Phase 3NDALicense out/inClinical ResultPhase 2

09 May 2024

·www.biospace.com

Verona Pharma Reports First Quarter 2024 Financial Results and Provides Corporate Update

PDUFA Target Action Date for Ensifentrine of June 26, 2024 Finalizing commercial launch preparations Strong balance sheet supports commercialization and pipeline expansion Conference call today at 9:00 a.m. EDT / 2:00 p.m. BST LONDON and RALEIGH, N.C., May 09, 2024 (GLOBE NEWSWIRE) -- Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), a biopharmaceutical company focused on respiratory diseases, announces its financial results for the first quarter ended March 31, 2024, and provides a corporate update. “As we approach the PDUFA target action date for ensifentrine of June 26, we are finalizing our preparations for a potential US launch in the third quarter of 2024,” said David Zaccardelli, Pharm. D., President and Chief Executive Officer. “If approved, ensifentrine is expected to be the first novel inhaled mechanism available for the treatment of COPD in more than 20 years, and we continue to work with the US Food and Drug Administration during their review. Our goal is to address the significant unmet need in COPD and provide a novel and effective treatment for patients that continue to experience symptoms, despite existing therapies. “We believe ensifentrine’s bronchodilator and non-steroidal anti-inflammatory activity has the potential to change the treatment paradigm for COPD and we look forward to providing updates later this year on our planned clinical programs for a fixed-dose combination of ensifentrine and glycopyrrolate in COPD and ensifentrine in non-cystic fibrosis bronchiectasis. “With the financing announced this morning, we are pleased to have further strengthened our balance sheet and enhanced our financial flexibility as we prepare for the potential launch of ensifentrine with access to up to $650 million in addition to our existing cash of $255 million. We refinanced our $400 million debt facility to one with a lower overall cost of capital and favorable financial covenants. In addition, we have entered into a $250 million capped revenue interest sales transaction with repayment based on a percentage of future ensifentrine revenues. We expect these funds, along with existing cash, to support the Company’s growth through the planned commercialization beyond 2026.” Program Updates and Key Milestones The Company’s near-term milestones include: The FDA has assigned a Prescription Drug User Fee Act (“PDUFA”) target action date for ensifentrine of June 26, 2024 and notified the Company that it is not currently planning to hold an advisory committee meeting to discuss the application. If approved, the Company intends to launch ensifentrine in the US market in the third quarter of 2024. In the second quarter of 2024, the Company continues to finalize key launch preparations including sales force deployment strategy, pricing, distribution and patient services, healthcare professional and patient engagement plans. In the second quarter of 2024, the Company will continue to highlight the burden of chronic obstructive pulmonary disease (“COPD”) through the "Unspoken COPD" disease awareness campaign. Through the first quarter of 2024, 85% of targeted healthcare professionals (“HCPs”) were reached with the campaign and over 2,000 HCPs engaged with the website. In May 2024, the Company will present eight posters including two mini oral symposia, at the American Thoracic Society International Conference (“ATS”) 2024. The posters will highlight additional pooled analyses of the Phase 3 ENHANCE studies with ensifentrine for the treatment of COPD. A pooled analysis demonstrating reductions in the rate and risk of exacerbations with ensifentrine will be presented as part of the ‘Late Breaking Mini Symposium’ designed to highlight new breakthroughs. In addition, the Company will host an exhibition booth exploring the role of phosphodiesterase (“PDE”) in inflammation and lung function impairment in COPD as well as three innovation hub presentations led by clinical experts. In the second half of 2024, the Company intends to submit an investigational new drug application (“IND”) to the FDA and, subject to clearance, initiate a Phase 2 clinical trial assessing the safety and efficacy of a fixed-dose combination formulation of ensifentrine and glycopyrrolate, a long-acting muscarinic antagonist (“LAMA”), for the maintenance treatment of patients with COPD via delivery in a nebulizer. Also in the second half of 2024, the Company plans to initiate a Phase 2 clinical trial to assess the efficacy and safety of nebulized ensifentrine in patients with non-cystic fibrosis bronchiectasis (“NCFBE”), subject to clearance by the FDA. Financing and Recent Highlights In May 2024, the Company refinanced its $400 million debt facility and entered into a $250 million capped revenue interest sales transaction with Oaktree Capital and OMERS Life Sciences (collectively “the $650 million strategic financing”). Also in May 2024, the Company presented posters at the International Society for Pharmacoeconomics and Outcomes Research (“ISPOR”) Annual International Conference 2024. Posters at ISPOR included claims data demonstrating exacerbations persist for patients even when they are receiving treatment regimens containing inhaled corticosteroids, resulting in a significant burden to the healthcare system. First Quarter 2024 Financial Results Cash position: Cash and cash equivalents at March 31, 2024, were $254.9 million (December 31, 2023: $271.8 million). The Company believes cash and cash equivalents at March 31, 2024, and funding expected to become available under the $650 million strategic financing facility, will enable Verona Pharma to fund planned operating expenses and capital expenditure requirements beyond 2026 including the commercial launch of ensifentrine in the US, if approved. R&D Expenses: Research and development (“R&D”) expenses were $6.8 million for the first quarter ended March 31, 2024 (Q1 2023: $12.6 million). This decrease of $5.8 million was primarily due to expense of $7.2 million in the three months ended March 31, 2023 for finalizing all matters related to the Phase 3 ENHANCE program. As the program completed in 2023, no similar costs were incurred in 2024. This decrease was partially offset by $1.5 million of pre-approval active pharmaceutical ingredient manufacturing-related costs as well as an increase of $0.7 million in people related costs including share-based compensation. SG&A Expenses: Selling general and administrative expenses (“SG&A”) were $20.4 million for the first quarter ended March 31, 2024 (Q1 2023: $9.6 million). The increase of $10.8 million was primarily due to an increase of $4.6 million related to marketing, commercial preparation and other pre-commercial activities, $1.1 million related to professional fees, consulting costs and other administrative expenses, which support our continued growth and evolution of our business, and $0.7 million related to the continued build-out of our information technology infrastructure. Additionally, people related costs increased by $4.1 million including share-based compensation as we increased our headcount in our commercial and support functions in preparation for the planned commercial launch. Net loss: Net loss was $25.8 million for the first quarter ended March 31, 2024 (Q1 2023: net loss $16.7 million). Conference Call and Webcast Information Verona Pharma will host an investment community webcast and conference call at 9:00 a.m. EDT / 2:00 p.m. BST on Thursday, May 9, 2024, to discuss the first quarter 2024 financial results and the corporate update. To participate, please dial one of the following numbers and ask to join the Verona Pharma call: +1-833-816-1396 for callers in the United States +1-412-317-0489 for international callers A live webcast will be available on the Events and Presentations link on the Investors page of the Company's website, and the audio replay will be available for 90 days. An electronic copy of the first quarter 2024 results press release will also be made available today on the Company’s website. For further information please contact: Verona Pharma plc US Tel: +1-833-417-0262 UK Tel: +44 (0)203 283 4200 Victoria Stewart, Senior Director of Investor Relations and Communications IR@veronapharma.com Argot Partners US Investor Enquiries Tel: +1-212-600-1902 verona@argotpartners.com Ten Bridge Communications International / US Media Enquiries Tel: +1-312-523-5016 tbcverona@tenbridgecommunications.com Leslie Humbel About Verona Pharma Verona Pharma is a biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of chronic respiratory diseases with significant unmet medical needs. In the third quarter of 2023, the US Food and Drug Administration accepted for review the Company’s NDA for ensifentrine for the maintenance treatment of patients with COPD and assigned a PDUFA target action date of June 26, 2024. If approved, ensifentrine has the potential to become the first inhaled non-steroidal therapy for the treatment of respiratory diseases that combines bronchodilator and anti-inflammatory activities in one molecule. The Company has evaluated nebulized ensifentrine in its Phase 3 clinical program ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) for COPD maintenance treatment. Ensifentrine met the primary endpoint in both ENHANCE-1 and ENHANCE-2 trials demonstrating statistically significant and clinically meaningful improvements in lung function. In addition, ensifentrine substantially reduced the rate and risk of COPD exacerbations in pooled analysis from ENHANCE-1 and ENHANCE-2. Two additional formulations of ensifentrine have been evaluated in Phase 2 trials for the treatment of COPD: dry powder inhaler (“DPI”) and pressurized metered-dose inhaler (“pMDI”) and a fixed-dose combination formulation with ensifentrine and glycopyrrolate, a LAMA, is currently under development, also for the treatment of COPD. Ensifentrine also has potential applications in cystic fibrosis, non-cystic fibrosis bronchiectasis, asthma and other respiratory diseases. For more information, please visit Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding our operational review, financial review, program updates and key milestones, the timing of the approval of the NDA for ensifentrine for the maintenance treatment of COPD, the development of ensifentrine in other formulations and for other indications and planned regulatory submissions and timing thereof, including the timing of submission of an IND for a fixed-dose combination formulation with ensifentrine and glycopyrrolate, a LAMA, for the maintenance treatment of patients with COPD and the timing of clinical studies to assess ensifentrine in patients with NCFBE, the planned US commercial launch of ensifentrine in 2024, the potential for ensifentrine to be the first therapy for the treatment of respiratory diseases to combine bronchodilator and non-steroidal anti-inflammatory benefits in one compound, the potential of ensifentrine to change the treatment paradigm for COPD patients, the potential of ensifentrine in the treatment of cystic fibrosis, NCFBE, asthma and other respiratory diseases, as well as the potential of the DPI and pMDI formulations of ensifentrine, the funding we expect to become available under our $650 million strategic financing facility, and the sufficiency of cash and cash equivalents, and the cash runway period provided by the sources of financing to fund planned operating expenses and capital expenditure requirements beyond 2026 including the commercial launch of ensifentrine in the US, if approved. These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from our expectations expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history; our ability to operate our business due to restrictions from our $400 million debt financing facility and any other existing or future indebtedness; our need for additional funding to complete development and commercialization of any future product candidates or development and commercialization of other formulations or target indications of ensifentrine, which may not be available and which may force us to delay, reduce or eliminate our product development programs or commercialization efforts; the reliance of our business on the success of ensifentrine, our only product candidate under development; economic, political, regulatory and other risks involved with international operations; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; serious adverse, undesirable or unacceptable side effects associated with ensifentrine, which could adversely affect our ability to develop or commercialize ensifentrine; we may not be successful in developing ensifentrine in other formulations or for multiple indications; our ability to obtain approval for and commercialize ensifentrine in multiple major pharmaceutical markets; misconduct or other improper activities by our employees, consultants, principal investigators, third-party service providers and licensees; our inability to realize the anticipated benefits under licenses granted by us to third parties to develop and commercialize ensifentrine, our future growth and ability to compete depends on retaining our key personnel and recruiting additional qualified personnel; material differences between our “top-line” data and final data; our reliance on third parties, including clinical research organizations, clinical investigators, manufacturers and suppliers, and the risks related to these parties’ ability to successfully develop and commercialize ensifentrine; lawsuits related to patents covering ensifentrine and the potential for our patents to be found invalid or unenforceable; lawsuits related to our licensing of patents and know-how with third parties for the development and commercialization of ensifentrine; changes in our tax rates, unavailability of certain tax credits or reliefs or exposure to additional tax liabilities or assessments could affect our profitability, and audits by tax authorities could result in additional tax payments for prior periods; and our vulnerability to natural disasters, global economic factors, geo-political actions and unexpected events, including health epidemics or pandemics, and conflicts such as the Russia-Ukraine conflict, which has and may continue to adversely impact our business. These and other important factors under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023, as updated in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Although management believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity, performance or achievements. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except as required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Verona Pharma plc Consolidated Financial Summary (unaudited) (in thousands, except share and per share amounts) Three months ended March 31, 2024 2023 Operating expenses Research and development 6,764 12,610 Selling, general and administrative 20,434 9,589 Total operating expenses 27,198 22,199 Operating loss (27,198 ) (22,199 ) Other income/(expense) Research and development tax credit 585 2,313 Interest income 3,378 2,677 Interest expense (1,586 ) (293 ) Foreign exchange (loss)/gain (219 ) 932 Total other income, net 2,158 5,629 Loss before income taxes (25,040 ) (16,570 ) Income tax expense (754 ) (173 ) Net loss $ (25,794 ) $ (16,743 ) Weighted-average shares outstanding – basic and diluted 645,701,197 621,450,900 Loss per ordinary share – basic and diluted $ (0.04 ) $ (0.03 ) Mar-31 Mar-31 2024 2023 Cash and cash equivalents $ 254,882 $ 291,415 Total assets $ 289,912 $ 323,146 Shareholders’ equity $ 224,988 $ 276,749

Phase 3Phase 2Financial StatementNDA

100 Deals associated with Glycopyrrolate

External Link

KEGG	Wiki	ATC	Drug Bank
D00540	Glycopyrrolate	A03AB02 R03BB06	DB00986

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Arrhythmias, Cardiac	US	Exela Pharma Sciences LLC	11 Jul 2018
Airway Obstruction	US	Novartis Pharmaceuticals Corp.	29 Oct 2015
Bronchitis, Chronic	US	Novartis Pharmaceuticals Corp.	29 Oct 2015
Pulmonary Emphysema	US	Novartis Pharmaceuticals Corp.	29 Oct 2015
Pulmonary Disease, Chronic Obstructive	EU	Novartis Europharm Ltd.	28 Sep 2012
Pulmonary Disease, Chronic Obstructive	JP	Novartis Pharma KK	28 Sep 2012
Pulmonary Disease, Chronic Obstructive	IS	Novartis Europharm Ltd.	28 Sep 2012
Pulmonary Disease, Chronic Obstructive	LI	Novartis Europharm Ltd.	28 Sep 2012
Pulmonary Disease, Chronic Obstructive	NO	Novartis Europharm Ltd.	28 Sep 2012
Sialorrhea	US	Merz Pharmaceuticals LLC	28 Jul 2010
Duodenal Ulcer	CN	Hunan Dongting Pharmaceutical Co., Ltd.	01 Jan 1982
Gastritis	CN	Hunan Dongting Pharmaceutical Co., Ltd.	01 Jan 1982
Stomach Ulcer	CN	Hunan Dongting Pharmaceutical Co., Ltd.	01 Jan 1982
Anesthesia	US	Hikma Pharmaceuticals USA, Inc.	06 Feb 1975
Peptic Ulcer	US	Casper Pharma LLC	11 Aug 1961

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Asthma	Phase 3	-	Novartis Pharmaceuticals Corp.	01 Mar 2015
Cerebral Palsy	Phase 3	US	Shionogi & Co., Ltd.	01 Mar 2007
Intellectual Disability	Phase 3	US	Shionogi, Inc.	01 Mar 2007
Headache	Phase 2	US	Mayo Clinic	19 Nov 2021
Post-Dural Puncture Headache	Phase 2	US	Mayo Clinic	19 Nov 2021
Reversal of Neuromuscular Blockade	Phase 1	CN	Jiangsu Huatai Chenguang Pharmaceutical Co., Ltd.	17 Sep 2020
Bradycardia	Phase 1	CN	GUANGDONG JIABO PHARMACEUTICAL CO LTD	20 Nov 2018
Kidney Diseases	Phase 1	RU	Novartis Pharma AG	01 Jun 2010
Kidney Failure, Chronic	Phase 1	RU	Novartis Pharmaceuticals Corp.	01 Jun 2010

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03939923 (CTgov)	Phase 4	Coronary Artery Disease	84	Glycopyrrolate+Neostigmine+Rocuronium (Neostigmine/Glycopyrrolate)	gnkvzlnbek(eyudjcuxld) = esvsjgktjw nicuxkcukl (qwnnpurzsw, ddvjouzvtc - ojkwsgghai) View more	-	22 Dec 2023
				sugammadex+Rocuronium (Sugammadex)	gnkvzlnbek(eyudjcuxld) = ldovfmshsz nicuxkcukl (qwnnpurzsw, nzchvkqjqa - kvimrsfhso) View more
NCT03742141 (CTgov)	Not Applicable	Vocal Cord Dysfunction	125	Intraoperative Video Laryngoscopy+Glycopyrrolate	rdtrtmprwy(yvimazkueb) = odsoodzigu yibniogrtd (nyabufkkhx, poyrmspxtf - sgluyioptk) View more	-	02 Oct 2023
NCT04401345 (Pubmed)	Phase 4	Anesthesia	258	Glycopyrrolate	aelemhkjcf(hfqjnudtuc) = zvzfybyevh dvyrfojgmv (cnottspvzu ) View more	Negative	25 Oct 2022
				Placebo	aelemhkjcf(hfqjnudtuc) = bbjzhpoivw dvyrfojgmv (cnottspvzu ) View more
EADV2022	Phase 3	Primary Axilary Hyperhidrosis	518	1% glycopyrronium bromide (GPB) cream	dqqezxoizr(vtvqrlxmtf) = hjdbpflsnp axuisetvnp (jcougkfmvf, 221.29)	-	07 Sep 2022
NCT04155047 (Pubmed)	Phase 4	Pulmonary Disease, Chronic Obstructive	22	Nebulized LAMA [glycopyrrolate (GLY) 25 µg]	mznovuqbqx(wkdhuwvita): P-Value = 0.0987	-	07 Jul 2021
				Placebo
NCT03084796 (CTgov)	Phase 2	Pulmonary Disease, Chronic Obstructive	733	CHF 5259 (Treatment A)	smyyrtswgv(tnzfarahzk) = aspfoyfdbf kwfajkddzh (jwsbunjtpo, ygrihlajff - kbjspsmxes) View more	-	15 Jun 2021
				CHF 5259 (Treatment B)	smyyrtswgv(tnzfarahzk) = qbugnxyfxu kwfajkddzh (jwsbunjtpo, scdrpgtwln - trajnnahcj) View more
NCT03880266 (CTgov)	Phase 2	Hyperhidrosis	72	Glycopyrronium cloth, 2.4% (Group 1 Active)	xumkursslo(oirxyxltsj) = wvlujktusj yhiabjmchl (lefluipdcy, tplhmyandf - qbyazqzozq) View more	-	15 Mar 2021
				Vehicle (Group 1 Vehicle)	xumkursslo(oirxyxltsj) = ptibyvdgjb yhiabjmchl (lefluipdcy, eierkwiqdg - imppjjbclg) View more
NCT03357393 (CTgov)	Not Applicable	Sedation	150	Midazolam+morphine+scopolamine (Midazolam and Morphine-scopolamine)	aqjwakrvcp(wguxxodvdx) = aoeztnlexv nlnuazliqh (usxnzlukce, bcvgeadavo - erkbzqroci) View more	-	05 Jan 2021
				Propofol-Lipuro+morphine+scopolamine (PCS (Propofol) With Morphine-scopolamine)	aqjwakrvcp(wguxxodvdx) = sulbgifaci nlnuazliqh (usxnzlukce, cvheocbznr - rxqodzwzdb) View more
NCT03358147 (CTgov)	Phase 2/3	Persistent asthma	1,077	GP MDI 28.8 μg (GP MDI 28.8 μg)	sbgemvgrdw(zydqqomjya) = oppzdfjgqw tgkplongnz (cvmjfxuugp, qchvygwwax - zjqsyodehl) View more	-	12 Aug 2020
				GP MDI 14.4 μg (GP MDI 14.4 μg)	sbgemvgrdw(zydqqomjya) = ddwohntgsu tgkplongnz (cvmjfxuugp, hxfzgqgias - dmkhkptdba) View more
NCT02872935 (CTgov)	Phase 4	Multiple Hamartoma Syndrome \| Nausea \| Vomiting	22	Normal saline (Placebo: Normal Saline)	rfvnnqpnio(jivxscmecm) = strlheicwo wpwnokspfy (jboibeoxbq, secyztzpec - hhqxdqyium) View more	-	09 Jun 2020
				Glycopyrrolate (Glycopyrrolate Group)	rfvnnqpnio(jivxscmecm) = psxsglnzkq wpwnokspfy (jboibeoxbq, ccnjsxdsxh - lynhbzsods) View more

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