Press release – No. 6 / 2022
Zealand Pharma Announces Oral Presentation of Phase 2
Data for BI 456906 at the 58th Annual Meeting of the European
Association for the Study of Diabetes (EASD)
- BI 456906 effectively lowered HbA1c up to -1.88% at week 16 in
patients with type 2 diabetes in the Phase 2 clinical trial
- Preclinical pharmacology of BI 456906 supports ongoing Phase 2
studies in obesity or non-alcoholic steatohepatitis
Copenhagen, Denmark and Boston MA, U.S. September 21,
2022 – Zealand Pharma A/S (CVR-no. 20045078) a
biotechnology company focused on the discovery and development of
innovative peptide-based medicines, today announced the
presentation of data from the Boehringer Ingelheim-sponsored Phase
2 clinical trial of BI 456906, a glucagon receptor/glucagon-like
peptide-1 receptor (GCGR/GLP-1R) dual agonist, in patients with
type 2 diabetes at the 58th Annual Meeting of the European
Association for the Study of Diabetes (EASD) being held in
Stockholm September 19 – 23, 2022. Preclinical data on BI 456906
will also be presented at the EASD annual meeting. BI 456906 is
being developed by Boehringer Ingelheim and was co-invented with
Zealand Pharma.
“We are delighted with the data presented at EASD from
Boehringer Ingelheim’s Phase 2 trial of the dual glucagon/GLP-1
receptor agonist BI 456906 that showed effective lowering of HbA1c
of up to -1.88% in people with type 2 diabetes at 16 weeks compared
to -1.47% observed following open-label treatment with the GLP-1
receptor agonist semaglutide,” said David Kendall, MD, Chief
Medical Officer of Zealand Pharma. “We look forward to the results
from this Phase 2 trial’s secondary endpoints related to the
changes in bodyweight following treatment with BI 456906 to be
reported at Obesity Week 2022 later this year.”
The abstracts of the oral presentations are available at
https://www.easd.org/programme-2022.html and the data are
summarized as follows:
Title: Multiple dose-ranging study of the novel
glucagon/GLP-1 receptor dual agonist BI 456906 vs placebo and
open-label weekly semaglutide reference control in type 2 diabetes
(Abstract number: 613)Authors: J. Rosenstock, M.
Blüher, B. Schmid, J. Hoefler, A. HennigeSession:
Short Oral Discussions Event D – SO 46 Incretins
everywhereDate and Time: Wednesday, 21 September
2022, 1:15 - 2:15 PM CET
Presentation Highlights: Treatment with BI
456906 resulted in dose-dependent HbA1c reductions, up to a maximum
of -1.88% at Week 16 in people with type 2 diabetes (T2D) and
showed greater HbA1c lowering than with open-label semaglutide
1.0mg in the Phase 2 trial. The safety and tolerability profile
that included gastrointestinal (GI) disorders, such as nausea and
vomiting, as the most frequently reported adverse events, was as is
expected with higher increasing doses of GLP-1 receptor agonists.
Most adverse events were reported during the dose-escalation phase
of the trial, and therefore slower escalation schemes may mitigate
the frequency.
- The Phase 2 placebo-controlled, double-blind trial enrolled
people with T2D on stable metformin background therapy.
Participants were randomized to receive multiple rising doses of BI
456906 in one of six dose groups, placebo or open-label weekly
semaglutide 1.0mg for 16 weeks. More information about the design
of the Phase 2 trial is at ClinicalTrials.gov (NCT04153929).
- Different doses of BI 456906 were escalated every 1–2 weeks to
ensure that 10 weeks were spent on a maintenance dose.
- The primary endpoint was the change from baseline in HbA1c
after 16 weeks of treatment. Secondary endpoints related to the
changes in bodyweight from baseline are expected to be reported
later this year.
- Treatment with BI 456906 led to dose-dependent decreases in
HbA1c, with mean reductions of -0.93% to -1.88% at 16 weeks across
the six dose groups, compared with -0.25% seen with placebo.
Treatment with open-label weekly semaglutide at 1.0mg led to a
decrease in HbA1c of -1.47%.
- Adverse events were reported in 78% of all participants
receiving BI 456906. Drug-related adverse events were reported for
59% of BI 456906-treated participants and 38% of participants
treated with open-label semaglutide. These were most frequently GI
disorders such as nausea and vomiting.
- Drug-related serious adverse events were reported for four
participants treated with BI 456906 across dose groups, all of
which resolved once treatment was stopped, and for no participants
receiving placebo.
- Adverse events led to treatment discontinuation in 16% of
patients receiving BI 456906, 5% receiving placebo and 4% receiving
open-label semaglutide.
- Slower dose escalations over a longer duration are expected to
mitigate GI adverse events.
Title: BI 456906, structural properties and
pharmacology of the novel glucagon and glucagon-like peptide-1
receptor (GCGR/GLP1R) dual agonist (Abstract number
570)Authors: R. Augustin, T. Zimmermann, L.
Thomas, T. Baader-Pagler, P. Haebel, E. Simon, H. Klein, R.
Santhanam, W. Reindl, B. Bajrami, W. Rist, I. Uphues, D. Hamprecht,
H. NeubauerSession: Short Oral Discussions Event E
– SO 41 Incretins: basic scienceDate and Time:
Thursday, 22 September 2022, 12:00 - 1:00 PM CET
Presentation Highlights: BI 456906, by
simultaneous activation of the GCGR and GLP-1R, achieved a body
weight lowering efficacy that is superior to GLP-1R agonist
semaglutide and is attributed to an increase in energy expenditure.
Transcriptional profiling provided insights into the mechanism of
action for BI 456906 in the liver with potential human relevance
for patients with NASH. Taken together, the pharmacology of BI
456906 suggests clinical benefits for patients with obesity and
patients with NASH which is in support of the current clinical
programs.
About BI 456906BI 456906 is a dual agonist,
acting on glucagon (GCG) receptors and glucagon-like peptide-1
(GLP-1) receptors to regulate energy and glucose homeostasis, and
which is expected to improve the metabolic profile of treated
individuals. BI 456906 has been shown to reduce bodyweight in
preclinical and clinical studies.
BI 456906 was co-invented by Boehringer Ingelheim through a
collaboration agreement with Zealand Pharma. Boehringer Ingelheim
is currently investigating the GCGR/GLP-1R dual agonist in two
phase 2 trials for people with obesity or who are overweight
(NCT04667377) and for people with non-alcoholic steatohepatitis
(NASH; NCT04771273). Under the terms of the agreement, Boehringer
Ingelheim funds all research, development and commercialization
activities related to BI 456906. Zealand Pharma is eligible to
receive up to EUR 345 million in outstanding milestone payments,
and high-single to low-double digit royalties on global sales.
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 Pharma A/Sank@zealandpharma.com
David Rosen (U.S. Media) Argot Partners
media@zealandpharma.com
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