The shares of Altimmune Inc. (NASDAQ: ALT) were down by -43.03% to $11.61 at the start of the trading on Wednesday despite the company reporting encouraging clinical study results. ALT closed Tuesday’s session at $20.38, down -0.39%.
ALT has announced what?
As a result of its 12-week Phase 1b study evaluating pemvidutide1, Altimmune (ALT) today released positive top-line results.
- Dr. Stephen A. Harrison, Medical Director at Pinnacle Research, served as the principal investigator for this randomized, double-blind, placebo-controlled trial.
- The subjects were randomly assigned 1:1:1:1 to receive 1.2 mg, 1.8 mg, or 2.4 mg pemvidutide or a placebo once a week for 12 weeks. With the 1.2 mg and 1.8 mg doses, no dose titration was used, while the 2.4 mg dose was titrated for four weeks.
- An evaluation of efficacy was conducted after 12 weeks of treatment with the primary endpoint being the percent reduction in liver fat from baseline, and the second endpoint is the weight loss from baseline after 12 weeks.
- In contrast to standard obesity trials, this trial did not incorporate any adjunctive diet or exercise interventions.
- An analysis of 94 subjects was conducted at 13 sites across the US with the mean BMI at baseline being 36 kg/m2, and the mean liver fat content is approximately 22%, as determined by MRI-PDFF.
- About 75% of the study subjects were Hispanic, and 27 (29%) had type 2 diabetes at baseline.
- There was no difference in the primary endpoint among the treatment groups taking pemvidutide.
Findings of the trial
- It was found that pemvidutide (with and without diabetes) reduced liver fat by 68.5% at 1.8 mg, with 94.4% of subjects achieving a 30% reduction in liver fat, 72.2% achieving a 50% reduction in liver fat, and 55.6% achieving a normalization of liver fat, defined as a liver fat fraction of less than 5%.
- Further, all subjects with baseline serum alanine aminotransferase levels exceeding 30 IU/L saw a decline of more than 17 IU/L at all dose levels, and 27.0 IU/L in the 2.4 mg group.
- The trial also met its key secondary endpoint in all pemvidutide treatment groups. As determined by an efficacy estimand, subjects without diabetes lost 4.9% of their body weight (placebo-adjusted 4.7%), compared to subjects with diabetes who lost 4.4% (placebo-adjusted 3.9%).
How does ALT see the results?
Altimmune (ALT) observed good tolerability and weight loss within the target range without dosage titration in the study. Furthermore, there was no clinically significant elevation in ALT levels. The positive results from the 24-week NAFLD trial have also encouraged ALT’s optimism regarding reporting results from the MOMENTUM obesity trial’s 24-week interim data.