Press release – No. 6 / 2022
Zealand Pharma Announces Oral Presentation of Phase 2 Data for BI 456906 at the 58th Annual Meeting of the
- 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
“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
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:
Session: Short Oral Discussions Event D – SO 46 Incretins everywhere
Date and Time: Wednesday,
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:
Session: Short Oral Discussions Event E – SO 41 Incretins: basic science
Date and Time: Thursday,
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 456906
BI 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
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