Anavex Provides Corporate Update, Announces Completion of Clinical Conduct of ADME and DDI Clinical Studies
Anavex completed clinical conduct of its DDI (65 participants) and ADME (8 participants) pharmacology studies of blarcamesine, both dosed at 30 mg with no serious adverse events observed in preliminary observations. The FDA cleared the company's IND for blarcamesine in Fragile X syndrome, and Anavex meets with the FDA in November to discuss adding pediatric participants to the Phase 3 Rett syndrome study. Full pharmacokinetic and safety analyses are ongoing; both blarcamesine indications carry Orphan Drug Designation.
Key figures
- Drug Name
- blarcamesine (ANAVEX 2-73)
- Phase Of Trial
- Phase 3 (Rett syndrome, ANAVEX2-73-RS-005)
- Dose
- 30 mg
- Ddi study participants
- 65
- Serious adverse events
- 0
- Adme study participants
- 8
AI analysis
Red flags3 · Pro
The rest of the AI analysis, red flags and sentiment are part of Signal8 Pro.
AI-generated analysis of a public disclosure. Not investment advice; verify against the original document.