Company announcement - No. 30 / 2024
Zealand Pharma announces that Boehringer Ingelheim's survodutide demonstrates breakthrough improvement in liver fibrosis with no worsening of MASH in 64.5% of patients with F2 and F3 fibrosis
- News builds on previously announced primary endpoint, which showed up to 83.0% of adults achieved statistically significant improvement in metabolic dysfunction-associated steatohepatitis (MASH) versus placebo (18.2%).
- New data on the secondary endpoint shows up to 52.3% of adults with fibrosis stages F1, F2 and F3 had improvement in fibrosis due to MASH.
- Additional sub-analysis shows up to 64.5% of adults with fibrosis stages F2 and F3 (moderate to advanced scarring) achieved an improvement in fibrosis without worsening of MASH.
- Survodutide to advance into Phase 3 MASH study; results reinforce its potential as a best-in-class MASH treatment and, with ongoing trials in obesity, could lead to clinically meaningful benefits across the cardiovascular, renal, and metabolic spectrum.
Copenhagen, Denmark, June 7, 2024 - Zealand Pharma A/S (Nasdaq: ZEAL) today announced that Boehringer Ingelheim has reported breakthrough results from a survodutide Phase 2 trial sub-analysis that demonstrate up to 64.5% of adults with fibrosis stages F2 and F3 (moderate to advanced scarring) achieved an improvement in fibrosis without worsening of metabolic dysfunction-associated steatohepatitis (MASH), versus 25.9% with placebo after 48 weeks of treatment [response difference: 38.6% (95% CI 18.1% - 59.1%), p=0.0005]. F2 and F3 patient populations are at increased risk of developing liver-related complications.
The full data results were presented today at the European Association for the Study of the Liver Congress (EASL) 2024 and published simultaneously in The New England Journal of Medicine. The secondary endpoint shows that up to 52.3% of adults treated with survodutide (BI 456906) achieved a significant improvement in liver scarring (fibrosis) stages F1, F2 and F3 (mild to moderate or advanced scarring), versus 25.8% with placebo after 48 weeks of treatment [response difference: 26.5% (95% CI 8.37% - 44.66%), p<0.01].
Today's news follows data announced earlier this year when the trial met its primary endpoint. These results demonstrated that up to 83.0% of adults achieved a statistically significant improvement of MASH versus placebo (18.2%), reinforcing the potential of survodutide as a best-in-class treatment [response difference: 64.8% (95% CI 51.1% - 78.6%), p<0.0001].
"We are very excited by the impressive Phase 2 trial results announced today by Boehringer Ingelheim for survodutide in MASH", said David Kendall, MD, Chief Medical Officer of Zealand Pharma. "These Phase 2 data provide evidence of clear differentiation that positions survodutide as a potential incretin-based treatment for both obesity and MASH. We are delighted that survodutide will advance into Phase 3 for the potential treatment of MASH."
In this trial, survodutide demonstrated safety data consistent with GLP-1 based molecules, with no new safety data concerns.
For additional information, please refer to Boehringer Ingelheim's press release from today available at Breakthrough Phase 2 survodutide data liver fibrosis MASH | Boehringer Ingelheim (boehringer-ingelheim.com).
About Survodutide (BI 456906)
Survodutide is a glucagon/GLP-1 receptor dual agonist that activates both the glucagon and GLP-1 receptors, which are critical to controlling metabolic functions.
Survodutide is licensed to Boehringer Ingelheim from Zealand Pharma, with Boehringer solely responsible for development and commercialization globally. Zealand has a co-promotion right in the Nordic countries. Survodutide was granted U.S. FDA Fast Track Designation in May 2021 for the treatment of MASH and fibrosis, and it was accepted to the EMA PRIME scheme in November 2023. Survodutide is also being evaluated in five Phase 3 trials for people living with overweight and obesity, both of which are associated with MASH. Further information is available on clinicaltrials.gov.
*Boehringer Ingelheim's Phase 2 trial is registered on clinicaltrials.gov as 'A Study to Test Safety and Efficacy of BI456906 in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3)' prior to a 2023 nomenclature recommendation made by a number of multinational liver societies including EASL, AASLD and ALEH to update non-alcoholic fatty liver disease (NAFLD) to metabolic dysfunction-associated steatotic liver disease (MASLD), and to update non-alcoholic steatohepatitis (NASH) with metabolic dysfunction-associated steatohepatitis (MASH).
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 Statement
This company announcement 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. 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, patient recruitment 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 at third party manufacturers; dependency on third parties, for instance contract research or development organizations; 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 the ongoing military conflict in Ukraine and the uncertainty surrounding upcoming elections in the US. 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 company announcement and are based on information available to Zealand Pharma as of the date of this 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.
Contact:
Adam Lange
Investor Relations Officer
Zealand Pharma
Email: akl@zealandpharma.com
Anna Krassowska, PhD
Vice President, Investor Relations & Corporate Communications
Zealand Pharma
Email: ank@zealandpharma.com
