Altimmune: Interim Phase 2 Obesity Trial and 12-Week Phase 1b Type 2 Diabetes Safety Trial

At Week 24, subjects receiving pemvidutide achieved mean weight losses of 7.3%, 9.4% and 10.7% at the 1.2 mg, 1.8 mg, and 2.4 mg doses, respectively, with the placebo group experiencing a mean weight loss of 1.0% (p < 0.001 at all three doses vs placebo, efficacy estimand using a mixed model of repeated measures [MMRM] analysis). An impact of baseline body weight was observed, where subjects with baseline body weight less than or equal to 115 kg (75% of the study population) achieved mean weight losses of 8.2%, 10.6%, 11.9% and 0.8% at the 1.2 mg, 1.8 mg, 2.4 mg and placebo groups, respectively (p < 0.001 at all three doses vs placebo). Approximately 50% of subjects achieved 10% or more weight loss and approximately 20% of subjects achieved 15% or more weight loss at Week 24 at the 1.8 mg and 2.4 mg doses. Robust reductions in waist circumference (a measure of visceral fat) and serum lipids were also observed, and clinically meaningful reductions in blood pressure were achieved without meaningful increases in heart rate. Glucose homeostasis was also maintained, with no significant changes in fasting glucose or HbA1c.

Regarding safety, upper GI events of nausea and vomiting comprised the majority of AEs. These events were predominantly mild and moderate in severity, dose-related and similar in frequency to those observed in prior trials of pemvidutide. Rates of lower GI AEs including diarrhea and constipation were notably low. This AE profile was observed in the absence of dose titration at the 1.2 mg and 1.8 mg doses and with a limited 4-week dose titration at the 2.4 mg dose. One subject (2.4%) experienced a serious adverse event of nausea and vomiting requiring rehydration at the 2.4 mg dose. Treatment discontinuation rates were 28.2% in subjects receiving placebo and 24.0% in subjects receiving pemvidutide. The majority of placebo discontinuations were due to withdrawal of consent, while approximately half of the withdrawals across the pemvidutide dose groups were attributed to GI AEs. These discontinuations occurred almost entirely in the first 16 weeks of treatment. The protocol did not allow for dose reduction due to intolerability as employed in other incretin trials.

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