Zealand Pharma announces that Boehringer receives U.S. FDA
Breakthrough Therapy designation and initiates two Phase III trials
in MASH for survodutide
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
Zealand Pharma AS (TG:22Z)
Historical Stock Chart
From Oct 2024 to Nov 2024
Zealand Pharma AS (TG:22Z)
Historical Stock Chart
From Nov 2023 to Nov 2024