Zealand Pharma's Petrelintide Shines In Phase 1b Trial, Paving The Way For Advanced Diabetes Therapy
Zealand Pharma's petrelintide shows promising weight loss results in Phase 1b trial for obesity treatment.
Breaking News
Jun 21, 2024
Mrudula Kulkarni
Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078), a
biotechnology firm specializing in the creation and advancement of novel
peptide-based medications, has reported encouraging top-line findings from the
second segment of a Phase 1b trial examining multiple ascending doses (MAD).
This trial evaluates the safety, tolerance, and therapeutic impacts of 16 weeks
of petrelintide dosing, a long-acting analog of amylin being developed for
weight management.
David Kendall, MD & Chief Medical Officer of Zealand
Pharma, said in a statement, “The data reported from this 16-week trial are
both exciting and compelling, demonstrating significant and clinically
meaningful reductions in body weight with a very favorable tolerability
profile. These results support our conviction that petrelintide is very well
tolerated and can potentially play an important role as an alternative to
incretin-based therapies for the management of overweight and obesity.
He further added, “These data pave the way for rapid
progression to Phase 2b trials of petrelintide and further support the
potential of this long-acting amylin analog to deliver weight loss comparable
to GLP-1 receptor agonists with a better patient experience. We look forward to
initiation of the Phase 2b clinical trial of petrelintide in people living with
overweight and obesity later in 2024.”
In the second phase of the Phase 1b MAD trial, 48
participants (approximately 80% male) with a median age of 49 years and a
median initial BMI of 29 kg/m² were randomly assigned to receive 16 weekly
doses of either petrelintide or placebo (in a 3:1 ratio) across three dose
groups. Among those who completed treatment with a high dose of petrelintide,
the average body weight decreased by 8.6% from the starting point. In contrast,
participants receiving placebo experienced an average decrease in body weight
of 1.7% from the baseline.
Petrelintide was well tolerated during the trial, with no
serious or severe adverse events reported. Most gastrointestinal side effects
were mild, except for one participant who experienced moderate nausea and
vomiting and discontinued treatment after the third dose. Importantly, no other
participants stopped treatment due to side effects.
Vomiting was not reported by any other participants, and
only two participants experienced mild diarrhoea. Nausea was reported by
between 16.7% and 33.3% of participants in the active treatment groups, and by
16.7% in the placebo group. Injection site reactions were rare and mild, and no
participants developed antibodies against the drug.