The main objective is to determine the feasibility of dasiglucagon in a bi-hormonal reactive closed loop system for automated glucose regulation (artificial pancreas; AP®) in patients with diabetes mellitus type 1. Safety parameters and pharmacodynamics are compared between Dasiglucagon and GlucaGen®.
This study is a single-center, double-blinded, randomized, cross over trial in 12 subjects. The subjects will be randomized to receive either dasiglucagon or GlucaGen® for the first three day study period and switch to the alternate treatment after a wash-out treatment.

Start Date29 Dec 2023

Sponsor / Collaborator

Inreda Diabetic BV

NCT05378672 / RecruitingPhase 3

A Phase 3, Single-administration, Open-label Trial to Assess the Efficacy, Safety, PK, and PD of Dasiglucagon When Administered as a Rescue Therapy for Severe Hypoglycemia in Pediatric Patients Below 6 Years of Age With Type 1 Diabetes

This research study will investigate whether dasiglucagon as a rescue therapy for participants between 1 and 6 years of age works and is safe to use. In addition, the study will investigate how dasiglucagon works in the body (pharmacokinetics and pharmacodynamics).
Participants will receive 1 single dose as an injection under the skin (subcutaneous, s.c.).
Participants will have 3 visits with the study team. For each participant, the study will last up to 84 days.

Start Date09 May 2023

Sponsor / Collaborator

Zealand Pharma US, Inc.

NCT04824872 / WithdrawnPhase 2

A Double-Blind, Placebo-Controlled, Cross-over Trial, Evaluating Efficacy and Safety of Dasiglucagon for Treatment of Post-bariatric Hypoglycemia in Roux-en-Y Gastric Bypass (RYGB) Operated Adults

The objective of the trial is to assess the effect of single subcutaneous doses of dasiglucagon versus placebo on post-prandial plasma glucose nadir following a Mixed Meal Test in Roux-en-Y Gastric Bypass (RYGB) subjects

Start Date01 Feb 2023

Sponsor / Collaborator

Zealand Pharma US, Inc.

100 Clinical Results associated with Dasiglucagon

100 Translational Medicine associated with Dasiglucagon

100 Patents (Medical) associated with Dasiglucagon

Literatures (Medical) associated with Dasiglucagon

01 Dec 2023·Diabetes care

Dasiglucagon Treatment for Postprandial Hypoglycemia After Gastric Bypass: A Randomized, Double-Blind, Placebo-Controlled Trial

Article

Author: Knop, Filip K ; Vilsbøll, Tina ; Houji, Inas J K ; Helsted, Mads M ; Krogh, Liva S L ; Hartmann, Bolette ; Øhrstrøm, Caroline C ; Johansen, Nicklas J ; Nielsen, Casper K ; Holst, Jens J

OBJECTIVE:

Postbariatric hypoglycemia affects >50% of individuals who have undergone Roux-en-Y gastric bypass surgery. Despite the often debilitating nature of this complication, existing treatment options are limited and often inefficient. Dasiglucagon is a stable glucagon analog available in a ready-to-use formulation and was recently shown to mitigate postbariatric hypoglycemia in experimental settings. Here, we aimed to evaluate the hypoglycemic hindering potential of dasiglucagon in an outpatient trial.

RESEARCH DESIGN AND METHODS:

We conducted a randomized, double-blind, placebo-controlled, crossover, proof-of-concept study at the Center for Clinical Metabolic Research at Gentofte Hospital in Denmark. The study included 24 individuals who had undergone Roux-en-Y gastric bypass surgery (n = 23 women) with continuous glucose monitor–verified postbariatric hypoglycemia (≥15 min at <3.9 mmol/L three or more times per week) randomly assigned to two treatment periods of 4 weeks of self-administered subcutaneous dasiglucagon at 120 μg or placebo. The primary and key secondary outcomes were continuous glucose monitor–captured percentage of time in level 1 and 2 hypoglycemia (<3.9 and <3.0 mmol/L), respectively.

RESULTS:

Compared with placebo, treatment with dasiglucagon significantly reduced time in level 1 hypoglycemia by 33% (−1.2 percentage points; 95% CI −2.0 to −0.5; P = 0.002) and time in level 2 hypoglycemia by 54% (−0.4 percentage points; 95% CI −0.6 to −0.2; P < 0.0001). Furthermore, dasiglucagon corrected hypoglycemia within 15 min in 401 of 412 self-administrations, compared with 104 of 357 placebo self-administrations (97.3% vs. 29.1% correction of hypoglycemia rate; P < 0.001). Dasiglucagon was generally well tolerated, with mostly mild to moderate adverse events of nausea.

CONCLUSIONS:

Compared with placebo, 4 weeks of self-administered dasiglucagon effectively reduced clinically relevant hypoglycemia in individuals who had undergone Roux-en-Y gastric bypass surgery.

01 Nov 2023·Diabetes therapy : research, treatment and education of diabetes and related disorders

Systematic Literature Review and Indirect Treatment Comparison of Three Ready-to-Use Glucagon Treatments for Severe Hypoglycemia.

Review

Author: Chenji, Suresh ; Giménez, Marga ; Khunti, Kamlesh ; Yan, Yu ; Matsuhisa, Munehide ; Syring, Kristen

INTRODUCTION:

Ready-to-use glucagon represents a significant advancement in the management of severe hypoglycemia for people with diabetes and their caregivers. This indirect treatment comparison (ITC) evaluated the efficacy and safety differences among the three ready-to-use glucagon treatments, Baqsimi^® (nasal glucagon), Gvoke^® (glucagon injection) and Zegalogue^® (dasiglucagon injection), in adults and children with type 1 diabetes (T1D) or type 2 diabetes (T2D).

METHODS:

A systematic literature review was conducted to identify randomized clinical trials assessing the efficacy and safety of Baqsimi, Gvoke or Zegalogue versus reconstituted, injectable glucagon (IG) in reversing insulin-induced hypoglycemia. Bayesian fixed-effect network meta-analysis was used to perform the ITC. Study endpoints included proportion of participants achieving treatment success, maximum blood glucose achieved, time to achieve treatment success and maximum blood glucose and treatment-emergent adverse events (TEAE).

RESULTS:

Ten clinical trials were included in the ITC (four for Baqsimi, three for Gvoke, and three for Zegalogue). All three treatments achieved high proportions of treatment success (> 98%). In adults, the efficacy results from combined T1D and T2D analysis were consistent with the T1D analysis, except statistically significantly faster in achieving treatment success for Baqsimi vs Gvoke in the combined analysis (13.96 vs 14.66 min). The mean maximum blood glucose values were also statistically significantly lower for Baqsimi (168 mg/dl) vs Gvoke (220 mg/dl) and Zegalogue (190 mg/dl). There was a trend towards a lower number of adults experiencing ≥ 1 TEAE with Baqsimi compared to Gvoke or Zegalogue, but no statistical significance was reached.

CONCLUSION:

Baqsimi, Gvoke and Zegalogue had comparable high proportions of treatment success in reversing insulin-induced hypoglycemia. Baqsimi achieved a lower mean maximum blood glucose value, which may have implications for the re-establishment of euglycemia. These findings may help support patients, caregivers and health care providers in their decision-making process when discussing various ready-to-use glucagon treatment options.

01 Jul 2023·Diabetologia

Pen-administered low-dose dasiglucagon vs usual care for prevention and treatment of non-severe hypoglycaemia in people with type 1 diabetes during free-living conditions: a Phase II, randomised, open-label, two-period crossover trial.

Article

Author: Schmidt, Signe ; Laugesen, Christian ; Ranjan, Ajenthen G ; Nørgaard, Kirsten

AIMS/HYPOTHESIS:

Consumption of excess carbohydrates to manage hypoglycaemia can lead to rebound hyperglycaemia and promote weight gain. The objective of this trial was to evaluate the efficacy, safety and feasibility of pen-administered low-dose dasiglucagon for prevention and treatment of non-severe hypoglycaemia in people with type 1 diabetes during free-living conditions.

METHODS:

Twenty-four adults with insulin pump-treated type 1 diabetes (HbA_1c ≤70 mmol/mol [8.5%]) completed a randomised, open-label, two-period crossover study with 2 week periods. During the usual care and dasiglucagon intervention (DASI) periods, participants managed impending and manifested episodes of hypoglycaemia with regular carbohydrate consumption or pen-administered low-dose (80 μg) s.c. dasiglucagon, respectively. Glycaemic control was evaluated using continuous glucose monitoring (Dexcom G6) and event registration of prevention and treatment episodes.

RESULTS:

Compared with usual care, the mean difference (95% CI) in the DASI period for time in (3.9-10.0 mmol/l) and below (<3.9 mmol/l) range was 2.4 %-points (-0.7, 5.5) and -0.5 %-points (-1.2, 0.2), respectively. In the DASI period, recovery rate (time from hypoglycaemia treatment to euglycaemia) was 44% (11, 87) faster while total daily carbohydrate intake was reduced by 11% (-18, -3). Dasiglucagon use was safe and well tolerated with mild nausea being the most frequent adverse effect. Among the participants, 96% (p<0.0001) were likely to include dasiglucagon in their future routine management of hypoglycaemia.

CONCLUSIONS/INTERPRETATION:

Use of low-dose dasiglucagon to prevent and treat non-severe hypoglycaemia during free-living conditions was safe, fast and efficacious while significantly reducing the total daily carbohydrate intake and yielding high treatment satisfaction.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT04764968 FUNDING: The study was an investigator-initiated trial. Zealand Pharma supplied the investigational drug and device and provided financial support for the conduct of the trial.

News (Medical) associated with Dasiglucagon

03 Jun 2024

·www.globenewswire.com

Zealand Pharma announces positive CHMP opinion for dasiglucagon for treatment of severe hypoglycemia in diabetes from European Medicines Agency

Zealand Pharma announces positive CHMP opinion for dasiglucagon for treatment of severe hypoglycemia in diabetes from European Medicines Agency May 31, 2024 – Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending granting marketing authorization for dasiglucagon solution for injection in the treatment of severe hypoglycemia in adults, adolescents, and children aged 6 years and over with diabetes mellitus. "We are very pleased that the European regulatory authorities have recommended approval of dasiglucagon as a rescue treatment for very low blood sugar in people with diabetes," said Adam Steensberg, Chief Executive Officer of Zealand Pharma. "This is an important step in achieving our ambition of bringing this product to many more patients around the world through our partnership with Novo Nordisk, a global leader in diabetes." The positive opinion from the CHMP will be referred to the European Commission (EC) for a final decision whether to grant marketing authorization in the European Union (EU). Zealand expects this decision within approximately three months. Dasiglucagon injection was approved by the U.S. FDA in March 2021 under the brand name Zegalogue®. Dasiglucagon injection was approved under the brand name Zegalogue® by the U.S. FDA on March 22, 2021, for the treatment of severe hypoglycemia in pediatric and adult people with diabetes aged 6 years and above. Zegalogue® is available in the U.S. in both an autoinjector and a prefilled syringe. The U.S. approval was based on results from three pivotal trials in adults and children with diabetes, showing a median time to blood glucose recovery from severe hypoglycemia of 10 minutes following injection of 0.6 mg/0.6 mL of dasiglucagon. In these Phase 3 trials, the most common adverse events reported (≥2%) were nausea, vomiting, headache, diarrhea, and injection site pain in adults; and nausea, vomiting, headache and injection site pain in pediatric patients. In September 2022, Zealand entered into a global license and development agreement with Novo Nordisk A/S to commercialize Zegalogue®. Under the terms of the agreement, Zealand is eligible to receive up to DKK 265 million in development, regulatory, manufacturing and sales-based milestones, as well as tiered royalties ranging from high single-digit to low double-digit percentages on worldwide net sales of Zegalogue® to be marketed by Novo Nordisk. Zealand is responsible for certain planned regulatory, development and manufacturing activities, including the Marketing Authorization Application (MAA) to the EMA, to support further development and approval outside of the U.S. Zealand retains all non-licensed intellectual property rights to the company’s other dasiglucagon development programs. Zealand Pharma A/S (Nasdaq: ZEAL) ("Zealand") is a biotechnology company focused on the discovery and development of peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market and three candidates are in late-stage development. The company has development partnerships with a number of pharma companies as well as commercial partnerships for its marketed products. Zealand was founded in 1998 and is headquartered in Copenhagen, Denmark, with a presence in the U.S. For more information about Zealand’s business and activities, please visit www.zealandpharma.com. The content above comes from the network. if any infringement, please contact us to modify.

Drug ApprovalLicense out/in

31 May 2024

·firstwordpharma.com

CHMP nods for haemophilia B gene therapy, chikungunya vaccine lead decisions from May meeting

At its May meeting, the European Medicines Agency's drug advisory body recommended 14 new medicines for approval, including one biosimilar and five generics, while it also backed extended labelling for seven treatments. In addition, the Committee for Medicinal Products for Human Use (CHMP) confirmed a negative opinion following a re-examination, and there were two marketing application withdrawals. All of the decisions can be found detailed below.Positive recommendations on new medicines: Takeda’s enzyme replacement therapy Adzynma (rADAMTS13) for the treatment of children and adult patients with congenital thrombotic thrombocytopenic purpura. SIFI’s Akantior (polyhexanide) for the treatment of acanthamoeba keratitis. CStone Pharmaceuticals’ anti-PD-L1 monoclonal antibody Cejemly (sugemalimab) for the treatment of adults with metastatic non-small-cell lung cancer (NSCLC). Pfizer’s gene therapy Durveqtix (fidanacogene elaparvovec) for the treatment of haemophilia B. AstraZeneca’s Fluenz (influenza vaccine [live attenuated, nasal]) for the prophylaxis of influenza in children and adolescents from 24 months to <18 years of age. Eckert & Ziegler’s GalliaPharm (germanium [68Ge] chloride / gallium [68Ga] chloride) for radiolabelling of various kits used for positron emission tomography (PET) imaging. Valneva’s Ixchiq (chikungunya vaccine [live]) to protect adults against disease caused by Chikungunya virus transmitted to humans by infected mosquitoes. Novo Nordisk’s Zegalogue (dasiglucagon) for the treatment of severe hypoglycaemia in adults, adolescents and children aged six years and over with diabetes mellitus. Bio-Thera Solutions’ biosimilar version of Avastin (bevacizumab), named Avzivi, for the treatment of carcinoma of the colon or rectum, breast cancer, NSCLC, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix. Five generic medicines also received a positive opinion: Apexelsin (paclitaxel) for the treatment of metastatic breast cancer; Dasatinib Accord Healthcare (dasatinib) for the treatment of chronic myelogenous leukaemia; and generic versions of pomalidomide from Accord Healthcare, Krka and Zentiva for treatment of multiple myeloma.Positive recommendations on extensions of therapeutic indication: Sanofi/Regeneron’s Dupixent (dupilumab) as an add-on maintenance treatment in adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood eosinophils. Bristol Myers Squibb/Pfizer’s Eliquis (apixaban) to include the treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from 28 days to <18 years of age. Calliditas Therapeutics/Stada’s Kinpeygo (budesonide) for the treatment of adults with primary immunoglobulin A nephropathy (IgAN). Mirum Pharmaceuticals’ Livmarli (maralixibat) to include progressive familial intrahepatic cholestasis in patients 3 months of age and older. AbbVie’s Skyrizi (risankizumab) for the treatment of adults with moderately to severely active UC who have had an inadequate response, lost response, or were intolerant to either conventional or biologic therapy. AstraZeneca’s Tagrisso (osimertinib) in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of adults with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. BeiGene’s Tevimbra (tislelizumab) alone for the treatment of adults with locally advanced or metastatic NSCLC after prior platinum-based therapy; in combination with pemetrexed and platinum‑containing chemotherapy for the first-line treatment of certain adults with non-squamous NSCLC whose tumours have PD-L1 expression on ≥50% of tumour cells with no EGFR or ALK positive mutations; and in combination with carboplatin and either paclitaxel or nab-paclitaxel for the first-line treatment of certain adults with squamous NSCLC.Negative opinions on new medicines: The CHMP confirmed its initial recommendation to refuse the granting of a marketing authorisation for Neuraxpharm and Minoryx Therapeutics’ Nezglyal (leriglitazone) for the treatment of cerebral adrenoleukodystrophy.Withdrawal of applications: Cytokinetics pulled a filing seeking approval of Kinharto (omecamtiv mecarbil) for the treatment of adults with symptomatic chronic heart failure and reduced ejection fraction. The decision was based on feedback from the EMA that supporting results were not sufficient to conclude that the benefits of the cardiac myosin activator outweigh the risks. Cytokinetics recently outlined plans to conduct another study of Kinharto. Clinuvel withdrew an application to expand use of Scenesse (afamelanotide) into adolescents with erythropoietic protoporphyria. The drug has been approved in this indication in the EU since 2014 for adults. However, the company determined that it was not possible to provide the comprehensive safety and efficacy data expected by the EMA in the expanded population.

Drug ApprovalVaccineClinical Result

16 May 2024

·www.globenewswire.com

Zealand Pharma Announces Financial Results for the First Quarter of 2024

Company announcement - No. 26 / 2024 Zealand Pharma Announces Financial Results for the First Quarter of 2024 Strong performance in the first quarter of 2024 paving the way for important data read-outs across differentiated obesity assets in the second quarter. Strong topline results announced in Boehringer Ingelheim Phase 2 clinical trial for survodutide in MASHPDUFA date for glepaglutide in SBS set by US FDA for December 22, 2024 PDUFA date for dasiglucagon in CHI for up to three weeks of dosing (Part 1 of NDA) set by US FDA for October 8, 2024Cash runway extended into 2027 through private placement of shares to institutional investors in January 2024 for gross proceeds of DKK 1.45 billion Copenhagen, Denmark, May 16, 2024 – Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced the interim report for the three months ended March 31, 2024, and provided a corporate update. Strong start to eventful 2024 Adam Steensberg, President and Chief Executive Officer at Zealand Pharma said: “I am very pleased with the continued advancement of our business in the first months of 2024. Our partner Boehringer Ingelheim reported impressive topline data from the Phase 2 trial with survodutide in MASH and recruitment into the Phase 3 trials in obesity is progressing very well. With our pipeline of wholly owned and differentiated obesity candidates, I am truly excited about the upcoming data read-outs for petrelintide and dapiglutide. In rare diseases, we have potential approvals in the US later in the year for both glepaglutide in short bowel syndrome and dasiglucagon in congenital hyperinsulinism. Backed by a solid financial position, we will continue to invest in our R&D programs, including preparations for comprehensive Phase 2b trials with our differentiated obesity candidates.” Key financial results for Q1 2024 DKK millionQ1 2024Q1 2023Revenue15.113.6Net operating expenses1-266.3-182.3Net operating result-255.8-168.7Net financial items25.8-26.7 DKK millionMar-31, 2024Mar-31, 2023Cash position23,234.81,633.1Funding available incl. undrawn committed RCF33,584.81,983.1 Notes: 1. Net operating expenses consist of R&D, S&M, G&A and other operating items. 2. Cash position includes cash, cash equivalents and marketable securities, as well as Tranche A of EIB loan disbursed in Q1 2024. 3. RCF = Revolving Credit Facility provided by Danske Bank. Highlights in the first quarter 2024 Obesity and MASH Survodutide, a glucagon/GLP-1 receptor dual agonist: Boehringer Ingelheim announced positive results from Phase 2 trial in MASH. The topline results showed that up to 83.0% of adults treated with survodutide achieved a biopsy-proven improvement in metabolic dysfunction-associated steatohepatitis (MASH) after 48 weeks without worsening of fibrosis stages F1, F2 and F3 (mild to moderate or advanced scarring), versus 18.2% with placebo. Survodutide also met all secondary endpoints, including a statistically significant improvement in liver fibrosis. These results will be presented at the European Association for the Study of the Liver (EASL) congress in Milan, Italy on June 7, 2024. Rare diseases Glepaglutide, GLP-2 analog: US FDA has granted a Prescription Drug User Fee Act (PDUFA) date of December 22, 2024. Zealand’s new drug application (NDA) is for glepaglutide administered twice weekly for the treatment of short bowel syndrome (SBS) with intestinal failure. Financial Solid financial position. Directed share issue of 3,761,740 new shares to two reputable institutional investors through a private placement for gross proceeds of DKK 1.45 billion, extending the cash runway into 2027. Tranche A of the EUR 90 million loan facility with the European Investment Bank (EIB), representing EUR 50 million, was disbursed and made available to Zealand in March 2024. Events after the reporting date Rare diseases Dasiglucagon (CHI): US FDA has granted a PDUFA date of October 8, 2024 for dasiglucagon in CHI for up to three weeks of dosing (Part 1 of NDA). The regulatory review is being conducted in two parts under the same NDA. Part 1 relates to dosing of up to three weeks, whereas Part 2 relates to use beyond three weeks. Supporting the review of Part 2, the US FDA has requested additional analyses from existing continuous glucose monitoring (CGM) datasets that were included as a secondary outcome measure in the Phase 3 program. Submission of Part 2 of the NDA is moved into the second half of 2024. Chronic Inflammation ZP10068, Complement C3 Inhibitor: Alexion has discontinued development of ZP10068 citing business reasons and plans to return the pre-clinical asset to Zealand. Upcoming events in 2024 Obesity Petrelintide, amylin analog. In the second quarter of 2024, Zealand expects to report topline results from Part 2 of the multiple ascending dose (MAD) trial that is evaluating petrelintide in participants with overweight or obesity (eligible BMI 27.0–39.9), including higher doses compared with Part 1 and over a longer 16-week treatment period. Dapiglutide, a GLP-1/GLP-2 receptor dual agonist. In the second quarter of 2024, Zealand anticipates topline results from the investigator-led DREAM trial that aims to evaluate the potential for weight loss following 12 weeks of treatment and gain key mechanistic insights into the effects of dapiglutide on inflammatory markers. In the second half of 2024, Zealand expects topline results from the 13-week dose titration trial, evaluating higher doses of dapiglutide compared to the prior 4-week MAD trial and the investigator-led DREAM trial.Survodutide in MASH. Boehringer Ingelheim will present results from the Phase 2 trial with survodutide in MASH at the EASL congress in Milan, Italy on June 7, 2024. Rare diseases Glepaglutide in SBS. In parallel with the regulatory review process, Zealand is engaging in partnership discussions for future commercialization. Dasiglucagon in CHI. Zealand is engaging in partnership discussions for future commercialization of the product. In parallel, Zealand intends to make the product available to patients in the US, contingent on an approval by the FDA in October 2024 for up to three weeks of dosing (Part 1 of NDA). Chronic Inflammation ZP9830, Kv1.3 Ion Channel Blocker. Zealand expects to initiate the first-in-human clinical trial of ZP9830 in the second half of 2024. Financial guidance for 2024 Guidance unchanged from February 27, 2024 DKK million2024 guidance2023 ActualRevenue anticipated from existing and new license and partnership agreementsNo guidance due to uncertain size and timing343Net operating expenses41,100-1,200896 Notes: 4. Financial guidance based on foreign exchange rates as of May 16, 2024. Conference call today at 2 PM CET / 8 AM ET Zealand’s management will host a conference call today at 2:00 PM CET / 8:00 AM ET to present results through the first three months of 2024 followed by a Q&A session. Participating in the call will be Chief Executive Officer, Adam Steensberg; Chief Financial Officer, Henriette Wennicke; and Chief Medical Officer, David Kendall. The conference call will be conducted in English. To receive telephone dial-in information and a unique personal access PIN, please register at https://register.vevent.com/register/BI3bf842a335dd49a79930cafce733506c. The live listen-only audio webcast of the call and accompanying slide presentation will be accessible at https://edge.media-server.com/mmc/p/ee4aippx. Participants are advised to register for the call or webcast approximately 10 minutes before the start. A recording of the event will be available following the call on the Investor section of Zealand’s website at https://www.zealandpharma.com/events/. Financial Calendar for 2024 Q2 2024 August 15, 2024Q3 2024 November 7, 2024 About Zealand Pharma A/S Zealand Pharma A/S (Nasdaq: ZEAL) (“Zealand”) is a biotechnology company focused on the discovery and development of peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market and three candidates are in late-stage development. The company has development partnerships with a number of pharma companies as well as commercial partnerships for its marketed products. Zealand was founded in 1998 and is headquartered in Copenhagen, Denmark, with a presence in the U.S. For more information about Zealand’s business and activities, please visit www.zealandpharma.com. Forward-looking Statements This company announcement and interim report contains “forward-looking statements”, as that term is defined in the Private Securities Litigation Reform Act of 1995 in the United States, as amended, even though no longer listed in the United States this is used as a definition to provide Zealand Pharma’s expectations or forecasts of future events regarding the research, development and commercialization of pharmaceutical products, the timing of the company’s pre-clinical and clinical trials and the reporting of data therefrom and the company’s Upcoming Events and Financial Guidance for 2023. These forward-looking statements may be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would” and other words and terms of similar meaning. You should not place undue reliance on these statements, or the scientific data presented. The reader is cautioned not to rely on these forward-looking statements. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions, which may cause actual results to differ materially from expectations set forth herein and may cause any or all of such forward-looking statements to be incorrect, and which include, but are not limited to, unexpected costs or delays in clinical trials and other development activities due to adverse safety events or otherwise; unexpected concerns that may arise from additional data, analysis or results obtained during clinical trials; our ability to successfully market both new and existing products; changes in reimbursement rules and governmental laws and related interpretation thereof; government-mandated or market-driven price decreases for our products; introduction of competing products; production problems; unexpected growth in costs and expenses; our ability to effect the strategic reorganization of our businesses in the manner planned; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; regulatory authorities may require additional information or further studies, or may reject, fail to approve or may delay approval of our drug candidates or expansion of product labeling; failure to obtain regulatory approvals in other jurisdictions; exposure to product liability and other claims; interest rate and currency exchange rate fluctuations; unexpected contract breaches or terminations; inflationary pressures on the global economy; and political uncertainty, including due to the ongoing military conflict in Ukraine. If any or all of such forward-looking statements prove to be incorrect, our actual results could differ materially and adversely from those anticipated or implied by such statements. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. All such forward-looking statements speak only as of the date of this press release/company announcement and are based on information available to Zealand Pharma as of the date of this release/announcement. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Information concerning pharmaceuticals (including compounds under development) contained within this material is not intended as advertising or medical advice. Zealand Pharma® is a registered trademark of Zealand Pharma A/S. Contacts: Adam LangeInvestor Relations OfficerZealand PharmaEmail: ALange@zealandpharma.com Anna Krassowska, PhDVice President, Investor Relations & Corporate CommunicationsZealand PharmaEmail: AKrassowska@zealandpharma.com Attachment Zealand Pharma - Q1 2024 Interim Report - 20240516

Clinical ResultPhase 2Financial StatementPhase 3NDA

100 Deals associated with Dasiglucagon

External Link

KEGG	Wiki	ATC	Drug Bank
D11359	-	A10BX	DB15226

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Hypoglycemia	US	Zealand Pharma US, Inc.	22 Mar 2021

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Congenital Hyperinsulinism	NDA/BLA	US	Zealand Pharma A/S	30 Jun 2023
Diabetes Mellitus, Type 1	Phase 3	US	Zealand Pharma US, Inc.	28 Jun 2017
Diabetes Mellitus, Type 1	Phase 3	AT	Zealand Pharma US, Inc.	28 Jun 2017
Diabetes Mellitus, Type 1	Phase 3	CA	Zealand Pharma US, Inc.	28 Jun 2017
Diabetes Mellitus, Type 1	Phase 3	DE	Zealand Pharma US, Inc.	28 Jun 2017
Hyperventilation	Phase 1	DE	Zealand Pharma US, Inc.	01 Dec 2014

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EASD2023	Not Applicable	Hypoglycemia	24	Dasiglucagon 120 µg	slhoqxezmf(wzpzxwseqk): P-Value = 0.002 View more	Positive	04 Oct 2023
				Placebo
NCT03777176 \| NCT04172441 (Biospace) Manual	Phase 3	Congenital Hyperinsulinism	44	Dasiglucagon (NCT04172441)	pqxqsabmdt(nzrmbtcqyx) = Skin reactions and gastrointestinal disturbances kemvnujqol (ocscplymsj ) View more	Positive	30 Aug 2023
				Dasiglucagon (NCT03777176)
NCT04764968 (Pubmed)	Phase 2	Hypoglycemia \| Diabetes Mellitus, Type 1	24	Dasiglucagon intervention (DASI)	nwitwqyecg(hpkxuvbpwm) = Dasiglucagon use was safe and well tolerated with mild nausea being the most frequent adverse effect tuxwpqrras (dqywqdejoo )	-	11 Apr 2023
NCT04172441 (ESPE2022) Manual	Phase 2/3	Congenital Hyperinsulinism	12	Dasiglucagon	qagfnmdpzc(jxsydeypay) = axonaklfjj dexkkyvcwx (lpqcgtfxtr, 4.9)	Positive	15 Sep 2022
				Placebo	qagfnmdpzc(jxsydeypay) = xzmvxulayh dexkkyvcwx (lpqcgtfxtr, 5.6)
NCT04172441 (ESPE2022) Manual	Phase 2/3	Congenital Hyperinsulinism	12	Dasiglucagon	mogzgfnwkx(imemubqdcx) = odpzvnwwaj rpydwjiwyz (ostqtjduni )	Positive	15 Sep 2022
				Placebo	-
ADA2022	Not Applicable	Hypoglycemia \| Diabetes Mellitus, Type 1	-	Dasiglucagon (Usual Care)	pngkpjnbyt(ypjoasasli) = Dasiglucagon use was safe and well tolerated with nausea being the most frequent adverse effect (no. of participants: UC: 4, DASI: 8) iymuztnutx (ipgctlynjv )	-	01 Jun 2022
				Dasiglucagon
NCT04172441 (GlobeNewswire) Manual	Phase 3	Congenital Hyperinsulinism	12	Dasiglucagon	zblrarykae(fxcbvctxqb) = aynopcopzd hprdegcmhm (ezorgcwetc )	Positive	19 May 2022
				Placebo	zblrarykae(fxcbvctxqb) = ciokjbuyvg hprdegcmhm (ezorgcwetc )
NCT04449692 (Pubmed)	Phase 2	Diabetes Mellitus, Type 1	20	Oral glucose (CHO)	cwgsbmwius(pepnhfhkmv) = Episodes of nausea were numerically, but not significantly, higher after dasiglucagon administration. xxlsdaxszd (avegsuhwll ) View more	Positive	27 Apr 2022
				Dasiglucagon 80 µg (D80)
NCT03688711 (Pubmed) Manual	Phase 3	Hypoglycemia	45	Dasiglucagon	qmramwfwza(vuihymncyl) = gznmjoyums ocnainkwtz (jozcqcleok, 8.0 ~ 12.0) View more	Positive	01 Oct 2021
				Placebo	qmramwfwza(vuihymncyl) = sxcknrrvbp ocnainkwtz (jozcqcleok, 20.0 ~ NR) View more
NCT03688711 \| NCT02660008 \| NCT03378635 \| NCT03216226 (EASD2021)	Phase 2/3	Hypoglycemia	220	Dasiglucagon 0.6 mg	ydgerxqlfg(hekbkluvvs) = zxvsdcbwhq xavlqvfqei (rtjppbotgx )	Positive	30 Sep 2021

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis