Acasti Pharma's IV Hemorrhage Drug Candidate At Par With Oral Nimodipine

  • Acasti Pharma Inc's ACST pharmacokinetic (PK) bridging study with IV GTX-104, its lead drug candidate for Subarachnoid Hemorrhage (SAH), met all its planned study endpoints
  • The study's primary objective was to evaluate the relative bioavailability of IV GTX-104 compared to oral nimodipine in healthy subjects, while the secondary objective was to assess its safety and tolerability. 
  • The company plans to submit these results to the FDA and its proposed study design for the Phase 3 safety study, which is on track to start in 2H of 2022. 
  • Also See: Acasti Pharma's Hemorrhage Candidate Shows Encouraging PK Profile In Healthy Volunteers.
  • All three endpoints indicated that statistically, there was no difference in exposures between IV GTX-104 and oral nimodipine over the defined periods for maximum and total exposure. 
  • Plasma concentrations obtained following IV administration showed significantly less variability between subjects than capsules.
  •  Less than one-tenth of nimodipine is delivered with GTX-104 to achieve the same blood levels as the oral capsules. 
  • No serious adverse events (AEs) and no AEs leading to withdrawal were reported.
  • Acasti also held $43.7 million in cash balance.
  • Price Action: ACST shares are down 4.98% at $0.92 during the market session on the last check Wednesday.

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