Biotech Values

[DewDiligence]

ALT—(+30%/AH)—reports (final) phase-2 weight-loss data:

https://www.globenewswire.com/news-release/2023/11/30/2788970/0/en/Altimmune-Announces-Positive-Topline-Results-from-MOMENTUM-48-Week-Phase-2-Obesity-Trial-of-Pemvidutide.html

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.

The dropout rate (26%) is still pretty high, but the 48-week data from this trial are clearly better than the 24-week (interim) data reported in Mar 2023 (#msg-171498058) that caused a steep selloff. Even after today’s AH bump, the stock is down more than 60% from its level prior to releasing the 24-week data.

CC tomorrow (Thursday) at 8:30am ET.