- Clinical-stage biotech Annovis Bio ( NYSE: ANVS ) added ~10% in the pre-market Thursday after the company announced that the FDA gave the go-ahead to a Phase 3 trial for oral experimental therapy buntanetap for the treatment of Parkinson's disease.
- Following a Type B meeting earlier this year, the regulator has accepted the final protocol and the clinical development plan for buntanetap, Annovis ( ANVS ) said.
- In addition, the FDA has greenlighted the use of the company’s new batch of good manufacturing practice material.
- The agency has noted that toxicology data for buntanetap based on animal studies would support long-term human studies compared to the previous restriction of one month.
- Its Chief Executive Maria L. Maccecchini announced that the company will start recruiting patients for the study later this summer. "With this FDA notice in hand, we are thrilled to start recruiting for the US clinical trial soon, expected later this summer," Maccecchini noted.
For further details see:
Annovis Bio wins FDA nod to begin late-stage study for Parkinson's candidate