Altimmune, FDA agree on efficacy measures for phase 3 trial of pemvidutide

seekingalpha
2024-11-08

Carolina Rudah/iStock via Getty Images

  • Altimmune (NASDAQ:ALT) and the U.S. FDA have reached agreement on the efficacy and safety measures to be evaluated in the company's phase 3 trials of obesity asset pemvidutide following an end-of-phase 2 meeting.
  • The phase 3 program will encompass four randomized, double-blind, placebo-controlled trials lasting 60 weeks and enroll a total of 5,000 participants. Three dosage strength will be tested -- 1.2 mg, 1.8 mg, and 2.4 mg -- and the company said it is aiming for approval of all strengths.
  • Each trial will enroll subjects with different comorbidities. For example, one will enroll individuals who are obese or overweight without diabetes, another in those with high LDL cholesterol, a third in those with elevated liver fat, and a fourth in an elderly population.
  • Pemvidutide is considered a novel peptide-based GLP-1/glucagon dual receptor agonist.

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