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Replies to post #246025 on Biotech Values
ALT’s weight-loss efficacy data are no better than what patients are already achieving with approved GLP-1 drugs such as NVO’s Wegovy and LLY’s Mounjaro, and its safety/tolerability data may be worse. Hence, the Pemvidutide program looks like it won’t be competitive unless the phase-3 data are considerably better than the (interim) phase-2 data, which is pretty unlikely.
06/24/23 2:44 PM
Data presented late yesterday appears to suggest once again that the only thing glucagon agonism adds to GLP-1 agonism is toxicity. The side effects of survodutide, the GLP-1/glucagon co-agonist being developed by Boehringer Ingelheim and Zealand Pharma, prompted high levels of discontinuation in a mid-stage obesity trial.
…It is the adverse event rates, and particularly AE-related discontinuations, that stand out. Nearly a quarter of patients on the highest dose of survodutide backed out of the trial citing side effects. This has strong echoes of the dropouts seen with Altimmune’s pemvidutide in its obesity study (#msg-171498058)…
…Boehringer and Zealand had hoped survodutide would escape this level of toxicity since it has eightfold greater affinity for the GLP-1 receptor than the glucagon receptor. [ALT’s ] pemvidutide is equimolar.
The results seen in obesity with survodutide and pemvidutide suggest that GLP-1/glucagon agonists are only roughly as effective as Wegovy...but much less safe.
11/30/23 6:12 PM
The trial enrolled 391 subjects with obesity or overweight with at least one co-morbidity and without diabetes. Subjects were randomized 1:1:1:1 to 1.2 mg, 1.8 mg, 2.4 mg pemvidutide or placebo administered weekly for 48 weeks in conjunction with diet and exercise. The 1.2 mg and 1.8 mg doses were administered without dose titration, while a short 4-week titration period was employed for the 2.4 mg dose. At baseline, subjects had a mean age of approximately 50 years, mean body mass index (BMI) of approximately 37 kg/m2 and mean body weight of approximately 104 kg [230 lbs]. Approximately 75% of subjects were female.
At Week 48, subjects…achieved mean weight losses of 10.3%, 11.2%, 15.6% and 2.2% at the 1.2 mg, 1.8 mg, and 2.4 mg doses and placebo, respectively, with a near-linear trajectory of continued weight loss observed on the 2.4 mg dose at the end of treatment. Over 50% of subjects achieved at least 15% weight loss and over 30% of subjects achieved at least 20% weight loss on the 2.4 mg dose.
As in prior clinical trials, pemvidutide resulted in robust reductions in serum lipids and improvements in blood pressure without imbalances in cardiac events, arrhythmias or clinically meaningful increases in heart rate. Glucose homeostasis was maintained, with no significant changes in fasting glucose or HbA1c.
…74.1% of pemvidutide subjects [completed] the trial compared to 61.9% of placebo subjects. Nausea and vomiting comprised the majority of adverse events (AEs) and were predominantly mild to moderate in severity.
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