This study is a randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of ensifentrine inhalation suspension (3 mg) delivered twice daily via standard jet nebulizer over at least 24 weeks, compared to placebo, in subjects with non-cystic fibrosis bronchiectasis (NCFBE).

Start Date11 Sep 2024

Sponsor / Collaborator

Verona Pharma Plc

NCT06460493 / Active, not recruitingPhase 3

A Study Assessing the Effect of Ensifentrine on CAT™ Scores Over 12 Weeks in Subjects with Moderate to Severe COPD

This is an open-label study at one study center that will assess the effect of twice-daily nebulized ensifentrine on COPD Assessment Test (CAT™) scores over 12 weeks in subjects with moderate to severe COPD. Subjects will continue their long-acting dual or triple COPD maintenance treatments during study participation.

Start Date11 Jun 2024

Sponsor / Collaborator

Verona Pharma Plc

[+1]

NCT05743075 / RecruitingPhase 3

A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of Ensifentrine Over 24 Weeks in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

This is a multi-center, randomized, double-blind, placebo-controlled, parallel-group clinical study, which aims to evaluate the efficacy, safety, and PK characteristics of Ensifentrine 3 mg twice daily (BID) for 24 weeks treatment of moderate to severe COPD.

Start Date10 Mar 2023

Sponsor / Collaborator

Nuance Pharma (Shanghai) Co., Ltd.Startup

[+1]

100 Clinical Results associated with Ensifentrine

100 Translational Medicine associated with Ensifentrine

100 Patents (Medical) associated with Ensifentrine

Literatures (Medical) associated with Ensifentrine

01 Jan 2025·RESPIRATORY MEDICINE

Safety and efficacy of ensifentrine in COPD: A systemic review and meta-analysis

Review

Author: Bushi, Ganesh ; Vishwakarma, Teena ; Serhan, Hashem Abu ; Balaraman, Ashok Kumar ; Prasad, G V Siva ; Malik, Praveen ; Yappalparvi, Ambanna ; Mehta, Rachana ; Prasad, G.V.Siva ; Pramanik, Atreyi ; Padmapriya, G. ; Lingamaiah, Doddolla ; Sah, Sanjit ; Zahiruddin, Quazi Syed ; Shabil, Muhammed ; Sharma, Promila ; Lal, Madan ; Punia, Ankit ; Kaur, Irwanjot ; Jagga, Megha ; Gaidhane, Shilpa ; Padmapriya, G ; Abu Serhan, Hashem ; Iqbal, Suhaib

BACKGROUND:

Chronic obstructive pulmonary disease (COPD) significantly impacts global health due to persistent airflow limitation and inflammation. Despite standard therapies, symptoms persist. Ensifentrine, targeting both bronchoconstriction and inflammation as a dual phosphodiesterase 3 and 4 inhibitor, offers a promising therapeutic advancement for COPD management. This meta-analysis evaluates the safety and efficacy of ensifentrine in improving lung function, dyspnea, and quality of life in COPD patients.

METHODS:

We searched PubMed, Embase, and Web of Science through August 2024 for randomized controlled trials evaluating ensifentrine in COPD patients over a minimum of four weeks. Data extraction and screening utilized Knowledge software, and meta-analyses were performed using R v4.4 with a random-effects model.

RESULTS:

From 206 studies identified, four met our inclusion criteria. Ensifentrine improved FEV1 significantly at a dose of 3 mg (LS mean difference: 40.90 mL; 95 % CI: 19.65-62.15). It also improved dyspnea as measured by the Transition Dyspnea Index (TDI) (LS mean difference: 0.91; 95 % CI: 0.61-1.21) and quality of life according to the St. George's Respiratory Questionnaire-C (SGRQ-C) scores (LS mean difference: -1.92; 95 % CI: -3.28 to -0.55). Safety profiles were comparable between the ensifentrine and placebo groups, with no significant increase in treatment-emergent adverse events (TEAEs) (RR: 1.02; 95 % CI: 0.94-1.10).

CONCLUSION:

Ensifentrine significantly enhances lung function, reduces dyspnea, and improves quality of life in COPD patients, especially at a 3 mg dose. These benefits, coupled with a stable safety profile, support its use as an adjunctive therapy in COPD management.

01 Jan 2025·Respiratory Investigation

Efficacy and safety of ensifentrine, a novel phosphodiesterase 3 and 4 inhibitor, in chronic obstructive pulmonary disease: A systematic review and meta-analysis

Review

Author: Nashwan, Abdulqadir J ; Akram, Umar ; Fatima, Maurish ; Chitwood, Joshua ; Fatima, Eeshal ; Larik, Muhammad Omar ; Ahmad, Arslan ; Esposito, Sarah ; Karamat, Riyan Imtiaz ; Nadeem, Zain Ali ; Rehman, Obaid Ur

BACKGROUND:

We evaluated the efficacy and safety of Ensifentrine in COPD via a systematic review and meta-analysis of randomized controlled trials (RCTs).

METHODS:

We performed a detailed literature search on Medline (via PubMed), Scopus, Google Scholar, and Cochrane on the basis of pre-specified eligibility criteria. We used Review Manager to calculate pooled mean differences (MD) and 95% Confidence Interval (CI) using a random effects model. The Cochrane's Risk of Bias 2 (RoB-2) tool was used to assess the risk of bias in the included RCTs.

RESULTS:

A total of 4 studies, consisting of 2020 patients, were included in the meta-analysis. The mean age ranged from 62.5 years to 65.5 years in the included studies. All the included studies were at low risk of bias. Ensifentrine 3 mg dose significantly improved the mean peak Forced Expiratory Volume-1 (FEV-1), morning trough FEV-1, TDI score, ERS score, and SGRQ-C score as compared to the placebo, yielding a pooled MD of 149.76 (95% CI, 127.9 to 171.6), 43.93 (95% CI, 23.82 to 64.05), 0.92 (95% CI, 0.64 to 1.21, -1.20 (95% CI, -1.99 to -0.40), and -1.92 (95% CI, -3.24 to -0.59), respectively.

CONCLUSION:

Ensifentrine is associated with improvements in outcomes related to COPD symptoms such as peak FEV-1, morning trough FEV-1 and TDI in the patients suffering from this chronic disease. It is also associated with improved quality of life as seen by E-RS score and SGRQ-C score.

01 Dec 2024·PULMONARY PHARMACOLOGY & THERAPEUTICS

Ensifentrine approval: A milestone in the treatment of COPD

Article

Author: Rogliani, Paola ; Calzetta, Luigino

147

News (Medical) associated with Ensifentrine

19 Dec 2024

·www.prnewswire.com

A Success Story: Digital Opinion Leader Analysis for Cystic Fibrosis Treatments | DelveInsight

A case study on how a pharmaceutical company specializing in cystic fibrosis treatments turned to DelveInsight for comprehensive analysis and insights into the digital cystic fibrosis landscape in the UK. DelveInsight identified key Digital Opinion Leaders (DOLs) and synthesized their opinions, enabling the client to strategically leverage these insights for drug development, marketing, and patient advocacy, ensuring a competitive edge in the cystic fibrosis market. LAS VEGAS, Dec. 19, 2024 /PRNewswire/ -- DelveInsight, a leader in healthcare competitive intelligence and consulting company, published a success study on Digital Opinion Leader (DOL) Analysis in the Cystic Fibrosis Market . A pharmaceutical company specializing in cystic fibrosis treatments approached DelveInsight to conduct an in-depth analysis of DOLs in the UK. The client sought to identify key digital influencers and understand their perspectives on cystic fibrosis treatments, leveraging these insights to inform drug development, marketing strategies, and patient advocacy efforts. Cystic fibrosis is a life-limiting autosomal recessive genetic disorder that primarily affects the lungs and digestive system, caused by mutations in the CFTR gene. According to DelveInsight's latest Cystic Fibrosis Market and Epidem Forecast Report, the estimated total diagnosed prevalent cases of cystic fibrosis in the 7MM in 2023 were ~68K cases. The UK had the highest number of diagnosed cystic fibrosis cases, with nearly 11K, followed by France with 7.5K and Germany with 7K. In the EU4 and the UK, the cystic fibrosis market size was nearly USD 7 billion, accounting for almost 39.4% of the total 7MM market size in 2023. This is expected to increase significantly by 2034. Download the Sample Report to Explore Future Trends in the Cystic Fibrosis Market In the field of cystic fibrosis, DOLs play a significant role in shaping perceptions and influencing the direction of treatment, policy, and patient care. These are influential healthcare professionals or researchers who have an active online presence and contribute to discussions, research, and advocacy. For pharmaceutical companies developing cystic fibrosis treatments, understanding the DOL landscape is crucial for gaining insights into market dynamics and stakeholder perceptions and identifying strategic opportunities for drug development, marketing, and patient advocacy. Several medications have been approved to manage cystic fibrosis, with therapies targeting the CFTR protein to correct its defects. One of the most groundbreaking treatments is TRIKAFTA, a combination of elexacaftor, tezacaftor, and ivacaftor, which has revolutionized cystic fibrosis treatment by improving lung function in patients with specific genetic mutations. Other notable drugs include SYMDEKO (tezacaftor/ivacaftor) and ORKAMBI (lumacaftor/ivacaftor), which also target the CFTR protein. These therapies aim to address the root cause of the disease, improving symptoms and quality of life for patients. However, despite these advancements, the current treatment landscape still faces challenges, such as variability in treatment efficacy and accessibility to newer therapies for certain patient populations. The pipeline for cystic fibrosis treatments continues to evolve, with several promising drugs in the cystic fibrosis pipeline. Ensifentrine (Verona Pharmaceuticals) is a dual inhibitor of the enzymes responsible for inflammation and mucus production in the lungs, showing potential as an add-on therapy for patients with CF. VX-121/TEZ/VX-561 (Vertex Pharmaceuticals) is another exciting treatment, combining triple therapy to enhance CFTR function and improve lung function. LAU-7b (Laurent Pharmaceuticals Inc.) aims to restore CFTR function and reduce inflammation. Lonodelestat (Pari Pharma GmbH) is being investigated for its ability to reduce neutrophil elastase and inflammation in the lungs of CF patients. These drugs, if successful, could significantly improve treatment options and outcomes for CF patients. Several companies are at the forefront of developing treatments for cystic fibrosis. Eloxx Pharmaceuticals, Inc. focuses on treatments that aim to restore protein function in CF patients with specific genetic mutations. Vertex Pharmaceuticals is a leader in the CF market, with therapies like TRIKAFTA and ongoing pipeline developments. Santhera Pharmaceuticals is exploring potential treatments to address pulmonary issues in CF patients. DelveInsight helped the client by curating insights from the digital cystic fibrosis landscape and analyzing the opinions of key digital influencers. By identifying and analyzing these DOLs, DelveInsight provided actionable insights and strategic recommendations for the client. The company gained a deeper understanding of the market dynamics, stakeholder perceptions, and the evolving digital landscape surrounding cystic fibrosis. These insights were invaluable for informing drug development strategies, understanding the gaps, patient burden,, and patient advocacy initiatives. Armed with comprehensive information on DOLs and their impact, the client was better equipped to make informed decisions, enhance patient engagement, and improve the overall market approach for cystic fibrosis treatments. Our client approached us with multiple objectives: Understand the DOL Landscape in the UK for cystic fibrosis. Identify Key Digital Opinion Leaders influencing discussions about cystic fibrosis. Analyze the Opinions of DOLs on treatment options and emerging therapies. Leverage Insights to refine drug development, marketing strategies, and patient advocacy efforts. Outcome of DelveInsight's Digital Opinion Leader Analysis: We identified and profiled key digital opinion leaders (DOLs) in the UK cystic fibrosis community, focusing on those with strong online presence, high engagement, and CF expertise. Through content analysis, we gained insights into opinions, trends, and key areas like treatment, patient care, advocacy, and research within the CF community. We mapped the CF digital ecosystem, highlighting connections and interactions between DOLs and stakeholders revealing network dynamics and engagement patterns. We assessed the impact of DOLs using metrics like follower count, engagement rate, and content virality, helping clients prioritize engagement strategies and collaborations. DelveInsight specializes in comprehensive Key Opinion Leader (KOL) and Digital Opinion Leader (DOL) opinion analysis, offering deep insights into industry trends, expert perspectives, and influencer dynamics. Our expertise enables clients to identify and understand the nerve of the trends by providing analysis through the most impactful thought leaders and digital influencers. By leveraging our tailored strategies and data-driven approaches, we help businesses strengthen their approach, refine decision-making, and amplify their market impact. Connect with us today to explore how we can support your specific needs and discuss opportunities for strategic engagement. Request a Proposal Now ! Why Choose DelveInsight? DelveInsight offers comprehensive expertise in the respiratory disease domain, providing in-depth market research, consulting services, and pipeline analysis tailored to the evolving needs of the industry. With a sharp focus on respiratory conditions, DelveInsight delivers robust reports covering emerging therapies, market trends, competitive landscapes, and unmet needs. DelveInsight's respiratory-specific solutions empower stakeholders to make data-driven decisions, optimize their R&D efforts, and seize growth opportunities in the dynamic and rapidly advancing respiratory disease market. Market Assessment Services in the Genetic Disorders Segment, DelveInsight, provide a 360-degree view of the market landscape. Our expertise includes epidemiology-based market forecasts up to 2034, offering precise insights into current and future market share uptake of emerging therapies. These forecasts, combined with detailed analyses of emerging trends, competitive dynamics of the pipeline therapies, and unmet needs, enable stakeholders to strategize effectively and identify growth opportunities. Whether it's the pipeline analysis, pricing strategies, or competitive benchmarking, DelveInsight delivers actionable intelligence tailored to your goals. Contact us Today to discuss how our services can drive success in your endeavors within the genetic disorder market. Competitive Intelligence Services Tailored to Genetic Disorder Domain: DelveInsight's competitive intelligence services provide real-time, accurate insights across the different therapeutic domains and genetic disorders being one of our fortes, providing detailed insights into advancements across rare and inherited conditions such as cystic fibrosis, Duchenne muscular dystrophy, and sickle cell anemia etc to name a few. Our services analyze competitors' pipelines, clinical trial progress, gene and cell therapy innovations, and market entry strategies, as well as regulatory updates and patent landscapes specific to genetic disorders. This intelligence enables stakeholders to identify emerging threats, uncover growth opportunities, and develop targeted strategies to remain competitive in this evolving therapeutic area. Connect with us today to explore how we can help you succeed in the genetic disorders market. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform , PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug Approval

19 Nov 2024

·www.globenewswire.com

Verona Pharma Announces December 2024 Investor Conference Participation

LONDON and RALEIGH, N.C., Nov. 19, 2024 (GLOBE NEWSWIRE) -- Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”) announces that senior management will present a company overview at the following conferences in December 2024: Piper Sandler 36th Annual Healthcare ConferenceDate: Tuesday, December 3, 2024Time: 12:00 p.m. ET / 5:00 p.m. GMTLocation: New York, NY 7th Annual Evercore HealthCONx ConferenceDate: Wednesday, December 4, 2024Time: 3:00 p.m. ET / 8:00 p.m. GMTLocation: Miami, FL A webcast of each conference presentation will be available on the Events and Presentations link on the Investors page of the Company’s website, www.veronapharma.com. For further information please contact: Verona Pharma plcTel: +1-844-341-9901Victoria Stewart, Senior Director of Investor Relations and CommunicationsIR@veronapharma.comArgot Partners(US Investor Enquiries)Tel: +1-212-600-1902verona@argotpartners.comTen Bridge CommunicationsInternational / US Media EnquiriesTel: +1-781-316-4424tbcverona@tenbridgecommunications.comWendy Ryan 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. Ohtuvayre™ (ensifentrine) is the Company’s first commercial product and the first inhaled therapy for the maintenance treatment of COPD that combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule. Ensifentrine has potential applications in non-cystic fibrosis bronchiectasis, cystic fibrosis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com.

14 Nov 2024

·www.globenewswire.com

Actimed Therapeutics Announces Professor David Ebsworth to Become Executive Chairman

Professor David Ebsworth to work closely alongside CEO Robin BhattacherjeeWill focus on fund raising efforts to support the planned IMPACT Phase 2b/3 trial for S-pindolol benzoate in cancer cachexiaProfessor Stefan Anker, Co-Founder of Actimed and Chair of the Scientific Advisory Board, also joins the Board of Directors London, UK – 14th November 2024. Actimed Therapeutics Ltd (“Actimed”), a UK based clinical stage specialty pharmaceutical company focused on bringing innovation to the treatment of cancer cachexia and other muscle wasting disorders, announces that Professor David Ebsworth will assume the role of Executive Chairman of Actimed. At the same time, Professor Stefan Anker, Founder and Chair of the Actimed Scientific Advisory Board, will join the Board of the Company as a Non-Executive Director. David has been Non-Executive Chairman of Actimed Therapeutics since April 2018. He has over 40 years of experience in the healthcare industry and is a past CEO of Galenica AG, Vifor Pharma AG and past global head of the Pharmaceutical Division of Bayer AG. David has chaired numerous private and public pharmaceutical companies and served on many Boards as either Chairman of the audit, remuneration or nominations and governance committees. David is Chair of the Supervisory Board at Synlab AG and Board member at Sartorius AG. David also currently serves as Chairman of Nasdaq listed Verona Pharma PLC, which he moved from AIM to Nasdaq in 2020. Verona recently gained approval for and has successfully launched Ohtuvayre (ensifentrine). David will work closely in partnership with CEO Robin Bhattacherjee to support the Company’s fund-raising activities to finance the planned Phase 2b/3 IMPACT clinical trial programme for Actimed’s lead asset, S-pindolol benzoate, in cancer cachexia. Actimed received FDA approval of its Investigational New Drug (IND) application for the IMPACT programme in August 2023. The Company plans to dose patients in 2025. Professor Stefan Anker, MD, PhD, co-founded Actimed Therapeutics in 2017, having previously founded Myotec (later renamed PsiOxus Therapeutics). Stefan has 30 years of academic research experience in cachexia and clinical trials development. He is founding Editor-in-Chief of the Journal of Cachexia, Sarcopenia and Muscle as well as the founding president of the International Society on Sarcopenia, Cachexia and Wasting Disorders. Stefan has been and is a member of more than 50 international clinical trial steering committees and is a named author on over 1,300 research papers. As Actimed advances the clinical development of S-pindolol benzoate, Stefan’s expertise and knowledge will provide important support to the Board and the Company. Robin Bhattacherjee, Chief Executive Officer of Actimed Therapeutics commented “I greatly look forward to David taking on the role of Executive Chairman and dedicating more time to advancing our efforts to bring S-pindolol benzoate to patients. David’s industry track record, contact network and Board expertise speak for themselves and will further strengthen our ability to finance and complete our planned clinical programme for this highly promising asset.” David Ebsworth, Executive Chair of Actimed added “I look forward to working more closely with Robin to achieve our objectives. I am deeply committed to ensuring success for Actimed in our mission to transform care for the many patients suffering from cancer cachexia and other muscle wasting disorders. Cancer cachexia remains a poorly treated condition with few recent advances in therapy. At Actimed, I believe we have an exciting opportunity to advance the standard of care when we successfully finance and complete the clinical development of S-pindolol benzoate and I am pleased to provide my full support to Robin and the Leadership Team in pursuit of this.” *** About Actimed Therapeutics Actimed Therapeutics is a clinical stage specialty pharmaceutical company focused on bringing innovation to the treatment of cachexia and other muscle wasting disorders, to transform the care of an underserved and vulnerable patient population. Cachexia is a wasting disease that is associated with cancer and other serious chronic illnesses and with significant morbidity and mortality. A significant number of cancer patients suffer from cachexia, and it is estimated that cachexia is responsible for up to 20% of all cancer deaths. Despite its prevalence and devastating clinical effects, there is no globally approved drug for the treatment or prevention of cancer-related cachexia. Actimed’s lead product, S-pindolol benzoate (ACM-001.1), targets multiple pathways that drive cachexia and has generated promising proof of concept Phase 2a clinical data in cachexia patients. Actimed is currently preparing for further clinical studies in cancer cachexia having received an Investigational New Drug (IND) approval from FDA for this programme in August 2023. Actimed also owns the global rights to its second asset, S-oxprenolol, which is being developed by the Company for the muscle wasting seen in amyotrophic lateral sclerosis (ALS) where loss of body mass and muscle wasting may impact survival. Actimed has licensed the global rights to develop and commercialise S-oxprenolol for cancer cachexia and any other indications outside of ALS to US company Faraday Pharmaceuticals. FOR MORE INFORMATIONActimed Therapeuticswww.actimedtherapeutics.com MEDiSTRAVA Frazer Hall, Erica HollingsworthTel: +44 (0)203 928 6900Email: actimed@medistrava.com ___________________________

Phase 2Executive ChangeDrug Approval

100 Deals associated with Ensifentrine

External Link

KEGG	Wiki	ATC	Drug Bank
D11743	Ensifentrine	-	DB16157

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Pulmonary Disease, Chronic Obstructive	US	Verona Pharma Plc	26 Jun 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Non-cystic fibrosis bronchiectasis	Phase 2	US	Verona Pharma Plc	11 Sep 2024
COVID-19	Phase 2	US	Verona Pharma, Inc.	04 Sep 2020
Cystic Fibrosis	Phase 2	GB	Verona Pharma Plc	08 Feb 2017
Moderate chronic obstructive pulmonary disease	Phase 2	-	Verona Pharma Plc	01 Jan 2017
Asthma chronic	Phase 2	SE	Verona Pharma Plc	01 Apr 2015
Asthma chronic	Phase 2	GB	Verona Pharma Plc	01 Apr 2015
Asthma	Phase 2	NL	Verona Pharma Plc	-
Asthma	Phase 2	-	Ligand UK Ltd.	-
Rhinitis, Allergic	Phase 2	NL	Verona Pharma Plc	-
Inflammation	Phase 1	GB	Verona Pharma Plc	01 Dec 2014

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04535986 \| NCT04542057 (ENHANCE-2, FDA_CDER) Manual	Phase 3	Pulmonary Disease, Chronic Obstructive	1,553	OHTUVAYRE (ENHANCE-1)	unhkhbgyfh(yaocyzgein) = lzyyihocpa ehuiyvldjd (jxsdeelggi, 25 - 97) View more	Positive	26 Jun 2024
				Placebo (ENHANCE-1)	unhkhbgyfh(yaocyzgein) = zsasxrypvg ehuiyvldjd (jxsdeelggi, -64 to 13) View more
ATS2024	Not Applicable	Pulmonary Disease, Chronic Obstructive	-	Nebulized ensifentrine 3 mg	israucnstd(amoglmthuv) = zsyqniannn aulqtettdk (icmupvgxyt, -8.5 to -3.3) View more	-	19 May 2024
				Placebo	israucnstd(amoglmthuv) = vhafxuzxll aulqtettdk (icmupvgxyt, -7.3 to -1.7) View more
ATS2024	Not Applicable	Pulmonary Disease, Chronic Obstructive	-	Ensifentrine 3 mg	cdkkmlkdsg(octrclujcv) = showed larger reductions with ensifentrine+LABA/ICS vs placebo+LABA/ICS at Weeks 6 and 12 misvcslqks (igjacgzity )	-	19 May 2024
				Placebo
ATS2024	Not Applicable	Pulmonary Disease, Chronic Obstructive	-	Nebulized ensifentrine 3 mg	aiarvbgudi(pdkogbimnp) = btxjkpxrkp drfjmevgur (ijydygyyca )	-	19 May 2024
ATS2024	Not Applicable	Pulmonary Disease, Chronic Obstructive	-	Ensifentrine 3 mg + LAMA	ayztrozdgs(lfibhrtiim) = xwkswepfxj tnlnzgyfth (hawwsfajet ) View more	-	19 May 2024
ATS2024	Not Applicable	Pulmonary Disease, Chronic Obstructive	-	Nebulized Ensifentrine 3 mg	ktyncdfnhp(xhstumcmvx) = srwduovpfj bapmytygew (jkruhflbws ) View more	-	19 May 2024
				Placebo	ktyncdfnhp(xhstumcmvx) = fdeqpwvfsi bapmytygew (jkruhflbws ) View more
ATS2024	Not Applicable	Pulmonary Disease, Chronic Obstructive	-	Nebulized ensifentrine 3 mg	gzbnyrzesu(hmpewnvzeb) = ssdddaciwp gajbuapqmm (vcojohosyr ) View more	-	19 May 2024
Phase 3 (ATS2024)	Phase 3	-	-	Ensifentrine 3 mg	ikyurxsdhy(bmgkpuedyx) = kdyyqrosqc sgplcchkwe (jyupsvjrhz )	Positive	19 May 2024
ENHANCE-1 (ERS2023) Manual	Phase 3	Pulmonary Disease, Chronic Obstructive	760	ENHANCE-1 was a 24-week (+48-wk subset), multi-center, randomized, double-blind, placebo-controlled trial to evaluate nebulized ensifentrine-3mg twice-daily (randomized 5:3) in subjects 40-80 years with symptomatic moderate-to-severe COPD (post-bronchodilator FEV1 30–70% predicted, FEV1/FVC ratio <0.7, >2mMRC), and smoking history >10 pack-years. Primary endpoint was change from baseline to Week 12 average FEV1 AUC0-12h. Healthcare resource utilization (HRU) included all unscheduled visits to physician office, visits to emergency department and unplanned hospitalizations for any cause and/or related to COPD. Exacerbation rate and time to first event were assessed. 760 subjects were randomized and treated. Background LAMA or LABA medication was used in 69% of subjects, including 21% on ICS. Results: The primary endpoint was met. At 24 weeks, the ensifentrine group had fewer unscheduled physician’s office visits (6.5% vs 10.6%) and emergency room attendance resulting in hospital admission (3.6% vs 4.9%) vs placebo. Ensifentrine reduced moderate/severe exacerbation rate (36%, p=0.050) and instant risk, as assessed by time to first exacerbation (38%, p=0.038) vs placebo. Ensifentrine reduced moderate exacerbation rate (RR=0.59 [95% CI 0.36, 0.97], p=0.036) and instant risk (HR=0.57 [0.35, 0.93], p=0.025) vs placebo. Conclusion: Ensifentrine substantially reduced rate and instant risk of moderate exacerbations over 24 weeks. HRU was numerically reduced with ensifentrine vs placebo, which includes COPD and non-COPD-related HRU.	rutilhhfia(lhqsfwvqaq) = vsvppezrip eghylcwgpb (nvoikshsge ) View more	Positive	11 Sep 2023
				Placebo	rutilhhfia(lhqsfwvqaq) = ianzmffylo eghylcwgpb (nvoikshsge ) View more
NCT04535986 \| NCT04542057 (ENHANCE Trials, Pubmed)	Phase 3	Pulmonary Disease, Chronic Obstructive	-	Ensifentrine	uxfpyqmssv(xcsbvcktbs) = hnyfvixblt qbstinnztq (wexszpetes, [55 - 119])	-	26 Jun 2023
				Placebo	-

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