Altimmune's ALT-801 Achieves 5.4% Weight Loss Surpassing Pre-Established Target Of 2%

  • Altimmune Inc ALT announced results from a prespecified 6-week interim analysis of its Phase 1 trial of ALT-801 in healthy, overweight, and obese volunteers.
  • The study is currently being conducted in Australia.
  • The data showed a mean weight loss of 5.4% was achieved by Week 6 with a once-weekly ALT-801 dose of 1.8 mg compared to a weight gain of 0.9% in the placebo group, surpassing the pre-established treatment target of 2% weight loss.
  • All but one subject who received the 1.8 mg dose achieved at least 3% weight loss.
  • A lower dose cohort that received a weekly 1.2 mg dose achieved a mean weight loss of 1.8%.
  • ALT-801 was well-tolerated without dose titration, with transient nausea rates of 14.3% at the 1.2 mg dose and 22.2% at the 1.8 mg dose, and no reports of vomiting, diarrhea, or constipation at either dose.
  • All nausea events at the 1.8 mg dose were mild in severity.
  • Results of 12 weeks of dosing are expected to be announced in Q3 2021. 
  • Altimmune will file an additional IND and initiate an obesity program in 2021.
  • The Company plans to conduct a separate 12-week Phase 1b study in non-alcoholic fatty liver disease (NAFLD) in the U.S., starting in Q3 of 2021.
  • It will also commence a 52-week biopsy-driven NASH trial in Q1 2022.
  • The Company will conduct a conference call today at 8:30 am E.T.
  • Price Action: ALT shares are up 4.74% at $14.8 during the premarket session on the last check Wednesday.
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