Zealand Pharma announces that Boehringer receives U.S. FDA Breakthrough Therapy designation and initiates two Phase III trials in MASH for survodutide

Zealand Pharma A-S

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Company announcement – No. 47 / 2024

Zealand Pharma announces that Boehringer receives U.S. FDA Breakthrough Therapy designation and initiates two Phase III trials in MASH for survodutide

• The U.S. FDA Breakthrough Therapy designation is for the treatment of adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) and moderate or advanced fibrosis, based on survodutide’s groundbreaking results from Phase II study 
• Boehringer launches two Phase III studies of survodutide, LIVERAGE in adults with MASH and moderate or advanced fibrosis (stages 2 or 3), and LIVERAGE-Cirrhosis in those with MASH and cirrhosis (stage 4)

Copenhagen, Denmark, October 8, 2024 – Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, reports that Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for survodutide (BI 456906), a dual glucagon/GLP-1 receptor agonist for the treatment of adults living with non-cirrhotic MASH and moderate or advanced fibrosis (stages 2 or 3). The Breakthrough Therapy designation expedites the development and review of medicines for serious or life-threatening diseases that have shown preliminary clinical evidence indicating substantial improvement over available treatments.

In addition, Boehringer announced the initiation of two Phase III clinical trials for survodutide for the treatment of adults living with metabolic dysfunction-associated steatohepatitis (MASH) and fibrosis (scarring).

LIVERAGE will examine whether survodutide can improve MASH and/or fibrosis after 52 weeks of treatment and reduce the risk of end-stage liver disease outcomes after approximately seven years of treatment in approximately 1,800 adults living with MASH and moderate or advanced liver fibrosis (stages 2 or 3). LIVERAGE-Cirrhosis will examine whether survodutide can reduce the risk of end-stage liver disease outcomes after approximately four and a half years of treatment in approximately 1,590 adults living with MASH and compensated cirrhosis (fibrosis stage 4), a condition where the liver presents severe scarring.

"Representing one of the most serious and fastest-growing obesity-related co-morbidities with limited treatment options available today, we are both pleased and excited to see Boehringer Ingelheim advance survodutide into two Phase III trials in MASH in both F2/F3 patients (moderate to advanced fibrosis) as well as F4 patients (cirrhosis),” said David Kendall, M.D., Chief Medical Officer of Zealand Pharma. "The U.S. FDA Breakthrough Therapy Designation follows the impressive and groundbreaking Phase II data with survodutide in MASH and fibrosis presented earlier this year which provided evidence of clear differentiation that position survodutide as a potentially leading incretin-based therapy for obesity and MASH in the future.”

For additional information, please refer to Boehringer Ingelheim’s press release from today available at Survodutide US FDA Breakthrough Therapy phase 3 trials MASH | Boehringer Ingelheim (boehringer-ingelheim.com).

About LIVERAGE and LIVERAGE-Cirrhosis
LIVERAGE and LIVERAGE-Cirrhosis are global Phase III clinical trials investigating the efficacy and safety of survodutide in adults with MASH and fibrosis stages 2 or 3 and in those with compensated MASH cirrhosis (stage 4), respectively. LIVERAGE will enroll approximately 1,800 adults, and LIVERAGE-Cirrhosis will enroll approximately 1,590 adults. In each trial, participants will be randomized to receive weekly injections of either survodutide, reaching a maximum dose of 6 mg, or placebo.

LIVERAGE consists of two parts. The two primary endpoints of part one are proportion of patients achieving MASH resolution without worsening of fibrosis, and at least a 1-point improvement in fibrosis without worsening of MASH, after 52 weeks of treatment. The primary endpoint of part two, which will continue for approximately seven years, is time to first occurrence of liver-related events or all-cause mortality.

The primary endpoint of LIVERAGE-Cirrhosis, which will continue for approximately four and a half years, is the time to first occurrence of all-cause mortality or liver-related events.

About survodutide (BI 456906)
Survodutide is a glucagon/GLP-1 receptor dual agonist that activates both the glucagon and GLP-1 receptors, which play a role in controlling metabolic functions. Survodutide is being evaluated in a robust Phase III clinical development program, including the LIVERAGE studies for people living with MASH and fibrosis and the SYNCHRONIZE studies for people living with overweight or obesity.

Survodutide’s potential to treat adults with non-cirrhotic MASH and moderate or advanced fibrosis (stages 2 or 3) has been recognized by the U.S. FDA, which granted it:

• Fast Track designation in May 2021 and;
• Breakthrough Therapy designation in September 2024.

Survodutide’s potential to treat adults with MASH and fibrosis has also been recognized by:

• the European Medicines Agency (EMA), through acceptance to its PRIME scheme in November 2023 and;
• the Center for Drug Evaluation of China’s National Medical Products Administration (NMPA), which granted it Breakthrough Therapy designation in June 2024.

Survodutide is licensed to Boehringer Ingelheim from Zealand Pharma, with Boehringer solely responsible for development and commercialization globally (subject to Zealand's co-promotion right in the Nordic countries).

About metabolic dysfunction-associated steatohepatitis (MASH)
MASH is a chronic and progressive liver disease caused by a build-up of fat in the liver and is a more severe form of metabolic dysfunction-associated steatotic liver disease (MASLD). In the US, cases of MASH are predicted to increase by 63% between 2015 and 2030, from 16.5 million to 27.0 million cases. MASH is a disease closely associated with connected cardiovascular, renal, and metabolic diseases, and it is estimated that 34% of people living with obesity also have MASH.

MASH severity is assessed using a scale that ranges from F0 to F4, which measures the level of fibrosis (scarring):

• F0-F1: indicates no or mild fibrosis
• F2-F3: indicates moderate or advanced fibrosis
• F4: indicates cirrhosis

About Zealand Pharma
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 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.

Contacts
Adam Lange (Investors)
Investor Relations Officer
Zealand Pharma
Email: alange@zealandpharma.com

Anna Krassowska, PhD (Investor and Media)
Vice President, Investor Relations & Corporate Communications
Zealand Pharma
Email: akrassowska@zealandpharma.com