Zealand Pharma A/S (ZEAL.CO) announced that its partner Boehringer Ingelheim has reported a positive trial readout of two global Phase III trials of its investigational drug Survodutide (BI 456906) in SYNCHRONIZE-1 for adults living with obesity or overweight, without type 2 diabetes and SYNCHRONIZE-MASLD for adults with overweight or obesity with metabolic dysfunction-associated steatotic liver disease (MASLD) with evidence of inflammation and/or fibrosis.
Overweight and obesity are complex chronic conditions involving abnormal or excessive fat accumulation that present a risk to a person's overall health.
Metabolic dysfunction-associated Steatotic liver disease, or MASLD, is a condition where excess fat builds up in the liver.
Survodutide
Survodutide is an investigational glucagon/GLP-1 receptor dual agonist that activates both receptors, which play a role in regulating metabolic functions. Survodutide is part of the Boehringer Ingelheim and Zealand Pharma collaboration
Zealand Pharma is eligible for high single- to low double-digit royalties on global sales of Survodutide, with up to 315 million Euros in potential outstanding milestone payments.
Trial Details
The SYNCHRONIZE-1 trial is a Phase III, double-blind, placebo-controlled, 76-week efficacy and safety trial of Survodutide in 725 adults living with obesity or overweight without type 2 diabetes.
SYNCHRONIZE-MASLD trial is a Phase III, double-blind, placebo-controlled 48-week efficacy and safety trial of Survodutide among 218 adults living with obesity and overweight and with MASLD with evidence of inflammation and or fibrosis versus placebo.
Key FindingsSYNCHRONIZE-1 Trial
-In the topline data announced in April, the 76-week Phase III SYNCHRONIZE-1 trial met its primary endpoints using both the treatment regimen (real-life environment) and efficacy estimands (controlled environment).
-Sustained weight loss of up to an average of 16.6% was observed using the efficacy estimand, a statistically significant decrease compared with 3.2% in the placebo arm.
-In addition, in the trial sub-study, a relative reduction of up to 34.0% in visceral fat loss was observed in patients who provided MRI measurements at baseline and at the end of the study.
-Lean mass accounted for no more than 10.8% of the change in total tissue mass at the highest dose, indicating weight loss driven by reductions in fat mass.
Also, a prespecified analysis showed adults treated with Survodutide had liver fat reduction of up to 63.1%, reflecting a metabolic health-supporting metric.
SYNCHRONIZE-MASLD Trial
-SYNCHRONIZE-MASLD trial investigated Survodutide for 48 weeks, and the study met its co-primary endpoints, with results showing that up to 84.2% of participants treated with Survodutide experienced at least a 30% relative liver fat reduction using the efficacy estimand, a statistically significant improvement over 24.3% in the placebo arm.
-The trial met its other co-primary endpoint with a relative reduction in body weight of up to 12.2% compared to 1.0% in the placebo arm.
-In addition, a secondary endpoint showed that up to 6 out of 10 patients (61.0%) achieved liver fat normalisation (liver fat content <5%) at Week 48 using the efficacy estimand, versus 5.7% in the placebo arm.
-Meanwhile, with respect to the adverse events, the following observations were made,In SYNCHRONIZE-1, the most commonly reported adverse events for Survodutide were gastrointestinal (GI) events, which were mostly mild to moderate in severity according to the firm.
-Notably, the treatment discontinuation rates due to GI adverse events were 19% in the Survodutide arm compared with 2.9% in the placebo arm.
Survodutide is also being studied in two global Phase III clinical trials LIVERAGE and LIVERAGE-Cirrhosis, investigating the efficacy and safety of Survodutide in adults with MASH and fibrosis stages 2 or 3 and in those with compensated MASH cirrhosis.
ZEAL.CO has traded between 233.50 Danish Kroner and 556.00 Danish Kroner over the last year. The stock closed Friday's trade at 326.30 Kroner.
ZEAL.CO is currently down 21.67% at 256.60 Danish Kroner.
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