Press release – No. 7 / 2022
Zealand Pharma
Announces
Presentations at
The Obesity Society Annual Meeting
- Results from the phase 2 clinical trial of GCGR/GLP-1R dual
agonist BI 456906 showing bodyweight reductions of up to 9% after
16 weeks in people with type 2 diabetes to be presented
- Four preclinical presentations highlighting effects of Zealand
Pharma’s three wholly owned peptide therapeutic candidates
(dapiglutide, ZP8396, ZP6590) on body weight, food intake,
tolerability and co-formulation
Copenhagen,
Denmark and Boston MA,
U.S. November 1,
2022 – Zealand Pharma A/S (Nasdaq: ZEAL) (“Zealand”)
(CVR-no. 20045078) a biotechnology company focused on the discovery
and development of innovative peptide-based medicines, today
announced presentations at the Obesity Society Annual Meeting
(Obesity Week) being held in San Diego, California from November
1-4, 2022. Presentations include preclinical data on Zealand’s
amylin analogue (ZP8396), its first-in-class GLP-1R/GLP-2R dual
agonist (dapiglutide) and from the company’s GIP analogue (ZP6590).
Clinical data from a Phase 2 trial of the GCGR/GLP-1R dual agonist
BI 456906, being developed by Boehringer Ingelheim and co-invented
with Zealand, will also be presented at Obesity Week.
“The science and data that we will present at this year’s
Obesity Week highlight our pipeline of therapeutic peptide
candidates under study for the potential treatment of obesity. We
have designed these novel peptides with complementary modes of
action to maximize the effect on weight management and to address
various clinical conditions associated with obesity, while
maintaining tolerability, by potentiating or adding to incretin
effects through either dual receptor targeting or by engineering
single receptor agonists that can be co-formulated with other
peptides. The preclinical data to be presented deepen our
understanding of the effects on body weight and food intake as well
as tolerability and the combination or co-formulation of
dapiglutide, our GLP-1R/GLP-2R dual agonist, and our amylin
analogue which are both in early phase clinical trials, as well as
our GIP analogue in late preclinical development,” said David
Kendall, MD, Chief Medical Officer of Zealand Pharma. “Clinical
results from the dual glucagon/GLP-1 receptor agonist BI 456906
from Boehringer Ingelheim’s Phase 2 trial in people with type 2
diabetes will be presented at Obesity Week. In the trial,
bodyweight reductions of up to 9% were observed after treatment
with BI 456906 for 16 weeks compared to 5.4% observed following
open-label treatment with the GLP-1 receptor agonist semaglutide.
We are extremely encouraged by the clinical data and the potential
of this molecule in patients with overweight or obesity.”
The presentation abstracts are available at
https://obesityweek.org/abstracts/ and are summarized as
follows:
Title: Amylin Analog ZP8396 Co-formulated With
Semaglutide Provides Additive Anti-obesity Effect in DIO
RatAuthors: P. Eriksson, J. Lundqvist, J. Griffin,
C. Wenander, J. Skarbaliene, and D. Kendall
Abstract: Poster-532Date and
Time: Friday November 4, 2022, 11:45am - 1:15pm PT
Presentation Highlights: Amylin analogue ZP8396
has been designed to allow co-formulation with other peptides.
Using an in vivo model of diet induced obesity, treatment with
ZP8396 co-formulated with GLP-1 analogue semaglutide achieved a
sustained and greater cumulative reduction in food intake and
resulted in sustained and greater body weight loss when compared to
monotherapy with either agent alone. The body weight reduction was
similar with ZP8396 and semaglutide administered as separate
injections (loose combinations) compared with co-formulation (-17.7
±1.0 with co-formulation, -16.1% ±0.7 with loose combinations,
-4.7% ±0.8 with ZP8396 alone, -8.0% ±0.8 with semaglutide alone,
+7.0% ±1.1 with vehicle). These preclinical data confirm the
feasibility of administering ZP8396 co-formulated with semaglutide
for the management of overweight and obesity and achieving greater
body weight loss when compared to monotherapy with either
agent.
Title: Anti-obesity Effect of Dapiglutide Alone
and in Combination With the Amylin Analog ZP8396 in DIO
RatAuthors: P. Eriksson, J.
Griffin, A. Nansen, J. Skarbaliene, and D.
KendallAbstract: Oral-019 Date and
Time: Wednesday November 2, 2022, 01:30pm - 1:45pm PT
Presentation Highlights: GLP-1R/GLP-2R dual
agonist dapiglutide and amylin analogue ZP8396 are currently both
being evaluated as monotherapy in clinical trials. In the current
study using an in vivo model of diet induced obesity, combination
therapy with dapiglutide and ZP8396, achieved a significant,
sustained and greater cumulative reduction in food intake and
resulted in significant, sustained and greater body weight
reduction compared to when either treatment was given as
monotherapy (-18.9% ±1.8 with combination therapy, -12.4% ±0.9 with
dapiglutide, -5.9% ±0.4 with ZP8396).
Title: Anti-obesity Effects of GIP Analogue
ZP6590 in Combination with Semaglutide in DIO
MiceAuthors: J. Skarbaliene, A. Nansen, and H.
RosenqvistAbstract: Poster-163Date and
Time: Wednesday November 2, 2022, 11:40am - 1:15pm PT
Presentation Highlights: GIP exhibits potent
incretin activity and may impact weight regulation. In this study
using an in vivo model of diet induced obesity, GIP analogue ZP6590
potentiated the body weight loss effects of GLP-1 monotherapy with
semaglutide despite negligible effects of ZP6590 alone (-24.1% ±1.3
with combination of ZP6590 and semaglutide, -13.7% ±2.3 for
semaglutide alone, 0.8% ±0.9 for ZP6590 alone). The potentiation of
body weight loss resulting from combination therapy in this model
was also observed if ZP6590 was added after maximal effect of GLP-1
monotherapy had been achieved. These preclinical results suggest a
synergistic potential of this combination in treating obesity.
Title: Potent Antiemetic Effect of GIP Analogue
ZP6590 in Ferrets, a Gold Standard Model for Emesis
TestingAuthors: J. Skarbaliene, C. Wenander, and
J. GriffinAbstract: Poster-164Date and
Time: Wednesday November 2, 2022, 11:40am - 1:15pm PT
Presentation Highlights: Some medications,
including GLP-1 analogues, are known to induce nausea and vomiting
in patients. GIP analogue ZP6590 exerted antiemetic effects in an
in vivo model challenged with the emesis-inducing agents morphine
or peptide YY3–36. These results suggest the potential therapeutic
advantages of combination therapies targeting GIP with other
drivers of malaise in the field of weight management, diabetes or
in the management of opioid-induced emesis.
Title: Glucagon/GLP-1 Receptor Dual Agonist BI
456906 Reduces Bodyweight in Patients With Type 2
DiabetesAuthors: J. Rosenstock,
M. Bluher, C. Schoelch, J. Hoefler, and A.
HennigeAbstract: Oral-063Date and
Time: Thursday November 3, 2022, 10:15am - 10:30am PT
Presentation Highlights: Treatment with the
GCGR/GLP-1R dual agonist BI 456906 resulted in dose-dependent
bodyweight reductions, up to a maximum of -9.0% in people with type
2 diabetes (T2D) and showed greater bodyweight loss than with
open-label semaglutide 1.0 mg 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 1.0 mg 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.
- Baseline mean age was 57 years, bodyweight 97 kg and BMI 25-50
kg/m2.
- Treatment with BI 456906 has dose-dependently reduced HbA1c in
patients with T2D on stable metformin therapy.
- Treatment with BI 456906 led to dose-dependent decreases in
bodyweight, with mean reductions of -1.9% to -9.0% at 16 weeks
across the six dose groups, compared with -1.2% seen with placebo.
Treatment with open-label weekly semaglutide at 1.0 mg led to a
decrease in bodyweight of -5.4%.
- Adverse events were reported in 77.8% of all participants
receiving BI 456906. These were most frequently GI disorders such
as nausea and vomiting. Adverse events led to treatment
discontinuation in 15.9% of patients receiving BI 456906.
- Slower dose escalations over a longer duration are expected to
mitigate GI adverse events.
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. Boehringer Ingelheim is
currently investigating the GCGR/GLP-1R dual agonist in two phase 2
trials for people with obesity or 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 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 Dapiglutide
Dapiglutide is a long-acting GLP-1R/GLP-2R dual agonist for the
potential treatment of obesity. In the Phase 1b multiple-ascending
dose clinical trial in healthy volunteers, dapiglutide showed dose
dependent weight loss over four weeks of treatment and was
well-tolerated. Results showed a plasma half-life allowing for once
weekly dosing and effects on several biomarkers suggest clinically
relevant exposures of dapiglutide were achieved.
About ZP8396ZP8396
is an investigational, potent long-acting amylin analogue designed
to improve solubility, minimize fibrillation and allow for
co-formulation with other peptides, including GLP-1 analogues.
Amylin analogues hold potential as both mono and combination
therapies for obesity. In preclinical studies ZP8936 has shown
potent anti-obesity effects. ZP8936 is currently being evaluated in
a Phase 1 clinical trial.
About ZP6590
ZP6590 is a long-acting glucose-dependent insulinotropic
polypeptide (GIP) analogue with a predicted half-life supporting
once-weekly dosing in humans. GIP exhibits potent incretin activity
and may impact weight regulation. Recent findings show that GIP
exerts antiemetic effects in models of GLP-1-induced emesis and
suggests a potential therapeutic advantage of combining GIP with
treatments known to induce emesis in patients.
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
Partnersmedia@zealandpharma.com
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