Company announcement – No. 41 / 2022
Zealand Pharma Announces Positive Results from Phase 3
Trial of Glepaglutide in Patients with Short Bowel Syndrome (EASE
1)
- Glepaglutide treatment met the primary endpoint with twice
weekly dosing achieving a statistically significant reduction in
weekly parenteral support volume by 5.13 Liters/week from baseline
at 24 weeks
- 66% of patients in the twice weekly group had a clinically
meaningful response (>20% reduction in parenteral support
volume)
- In total 9 patients treated with glepaglutide were weaned off
parenteral support, while no placebo treated patients were able to
wean off parenteral support
- Glepaglutide treatment was assessed as safe and was
well-tolerated in the trial
- Conference call scheduled today at 8:00 a.m. ET / 2:00 p.m.
CET
Copenhagen, Denmark and Boston MA, U.S. September 30,
2022 – Zealand Pharma A/S (CVR-no. 20045078,) a
biotechnology company focused on the discovery and development of
innovative peptide-based medicines, today announced positive
topline results from the pivotal Phase 3 trial of glepaglutide, a
long-acting GLP-2 analogue designed for once or twice weekly
subcutaneous delivery via auto-injector, in patients with short
bowel syndrome (SBS).
A total of 106 SBS patients with intestinal failure who were
dependent on parenteral support (PS) for at least three days per
week were evenly randomized to receive treatment with 10 mg
glepaglutide administered either once or twice weekly, or placebo.
The primary endpoint in the trial was the absolute change in weekly
parenteral support volume from baseline at 24 weeks.
Glepaglutide given twice weekly significantly reduced the total
weekly volume of parenteral support at 24 weeks as compared to
placebo (p=0.0039). When administered once weekly, glepaglutide
treatment also resulted in a numeric reduction in weekly parenteral
support, however this did not achieve statistical significance. At
24 weeks, the average reduction in parenteral support from baseline
was 5.13 Liters/week for patients treated with glepaglutide twice
weekly and was 3.13 Liters/week for patients treated with
glepaglutide once weekly. Placebo treatment resulted in a reduction
in parenteral support of 2.85 Liters/week.
Clinical response, defined as a patient achieving at least 20%
reduction in weekly parenteral support volume from baseline at both
20 and 24 weeks, was significantly higher with twice weekly
glepaglutide compared to placebo (p=0.0243). Among patients
receiving glepaglutide twice weekly 65.7% achieved a clinical
response. While 45.7% and 38.9% of patients achieved a clinical
response in the once weekly and placebo treatment groups,
respectively.
In the twice weekly dosing group, 14% of patients (n=5) were
completely weaned off parenteral support (enteral autonomy). In
total 9 patients treated with glepaglutide achieved enteral
autonomy, while no placebo treated patients were able to
discontinue parenteral support.
“We are extremely pleased with the results of the Phase 3
EASE 1 trial,” said David Kendall, M.D., Chief Medical Officer of
Zealand Pharma. “In EASE 1, glepaglutide significantly reduced the
volume of parenteral support required compared to placebo when
administered to patients with SBS and intestinal failure. We are
particularly encouraged that a number of patients treated with
glepaglutide were able to significantly reduce the burden of
parenteral support – both reducing the number of days and
completely eliminating the need for parenteral support in a
substantial number of patients. We believe the outcome of this
trial supports the potential of glepaglutide as an effective
treatment for people living with SBS and intestinal failure and can
reduce the burden of both parenteral support and daily dosing of
GLP-2 treatment. We look forward to seeing the results of the
ongoing EASE 2 and 3 long term extension trials and engaging with
the regulatory authorities as we plan for submission of our
NDA.”
Glepaglutide appeared to be safe and was well-tolerated in the
trial. The most frequently reported adverse events were injection
site reactions and gastrointestinal events. In total, 102 of 106
participating patients completed the trial, of which 96 continued
into the ongoing safety and efficacy extension trials, EASE 2 and
EASE 3.
“We are enormously privileged to have such a rich pipeline of
proprietary peptides that in the last six months have reported two
positive Phase 3 trials for two separate programs aimed at changing
the lives of patients living with rare and severe diseases,” said
Adam Steensberg, M.D., Chief Executive Officer of Zealand Pharma.
“Today’s robust results for glepaglutide represent a tremendous
milestone for Zealand and patients living with SBS, and we are
well-positioned to continue toward delivering next generation
peptide therapeutics that make a difference to patients’
lives,”
Conference call today at 2 PM CET / 8 AM ET
Zealand’s management will host a conference call and webcast
today at 2:00 pm CET / 8:00 am ET to discuss topline results from
the Phase 3 EASE 1 trial followed by a Q&A session.
Participating in the call will be Chief Executive Officer, Adam
Steensberg, and Chief Medical Officer, David Kendall. The
conference call will be conducted in English.
Telephone dial-in information and a unique personal access PIN
will be provided upon registration at
https://register.vevent.com/register/BI20c985a584b842489c0009561f316e59.
A live listen-only audio webcast of the call, including an
accompanying slide presentation, will be accessible at
https://edge.media-server.com/mmc/p/9n7vxaw3. 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-cal.
About EASE 1
EASE 1 is a randomized, double-blind Phase 3 trial to evaluate
the safety and efficacy of once- and twice-weekly subcutaneous
administration of glepaglutide compared to placebo in up to 108 SBS
patients with intestinal failure who were dependent on perenteral
support (PS) at least three days per week. The trial is designed to
confirm the efficacy of glepaglutide in reducing the parenteral PS
volume and to evaluate the efficacy of glepaglutide on other
efficacy endpoints as well as the safety and tolerability of
glepaglutide in patients with SBS. The primary endpoint in the
trial is the absolute change in weekly PS volume from baseline at
24 weeks. Participants in EASE 1 may subsequently enroll in the
extension trials, EASE 2 and 3, designed to assess long-term safety
and efficacy of glepaglutide. EASE 4 is a Phase 3b trial to assess
long-term effects of glepaglutide on intestinal fluid and energy
uptake. For more information on the EASE trials, please visit
ClinicalTrials.gov (IDs: NCT03690206, NCT03905707, NCT04881825,
NCT04991311).
About Short Bowel Syndrome
Short Bowel Syndrome (SBS) is a complex chronic and severe
condition associated with reduced or complete loss of intestinal
function. Many patients have to be connected to infusion lines and
pumps every day, which pose significant restrictions on their
ability to engage in daily activities. In addition, they are at
risk of experiencing a number of serious and life-threatening
complications such as sepsis, blood clots, liver damage and renal
impairment.
About Glepaglutide
Glepaglutide is a long-acting GLP-2 analog in development as a
potential treatment option for short bowel syndrome (SBS).
Glepaglutide is being developed as a liquid product in an
autoinjector designed for subcutaneous administration, aimed to
reduce, or eliminate, the need for parenteral support in people
living with SBS. The U.S. Food and Drug Administration (FDA) has
granted orphan drug designation for glepaglutide for the treatment
of SBS.
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 and partnerships with a number of blue-chip
pharma companies as well as commercial partnerships for its
marketed products.
Founded in 1998 and headquartered in Copenhagen, Denmark,
Zealand has a team in the U.S. For more information about Zealand’s
business and activities, please visit
http://www.zealandpharma.com.
Forward-Looking Statements
This press release contains “forward-looking statements”, as
that term is defined in the Private Securities Litigation Reform
Act of 1995, as amended, that provide Zealand Pharma’s expectations
or forecasts of future events regarding the research, development
and commercialization of pharmaceutical products. 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, the occurrence of adverse safety events; risks
of unexpected costs or delays; unexpected concerns that may arise
from additional data, analysis or results obtained during clinical
trials; 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 fail
to approve or may delay approval of our drug candidates or
expansion of product labelling; failure to obtain regulatory
approvals in other jurisdictions; product liability claims; and the
direct and indirect impacts of the ongoing COVID-19 pandemic on our
business, results of operations and financial condition. 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 and are based on information available to
Zealand Pharma as of the date of this release. 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:
Anna Krassowska, PhDVice President, Investor Relations &
Corporate CommunicationsZealand PharmaEmail:
ank@zealandpharma.com
David Rosen (U.S. Media)Argot PartnersEmail:
media@zealandpharma.com
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