The first patient has been dosed in a clinical trial testing Annovis Bio’s buntanetap as an oral therapy for early-stage Parkinson’s disease, the company announced.
The Phase 3 clinical trial (NCT05357989) got started shortly after the U.S. Food and Drug Administration (FDA) gave the company the green light to start recruiting up to 450 patients with idiopathic (of unknown cause) Parkinson’s disease. Recruitment is ongoing at three locations in the U.S.
The trial’s launch was grounded on positive findings from a placebo-controlled Phase 2a clinical trial (NCT04524351) that included patients with Parkinson’s and with Alzheimer’s, another neurodegenerative disease for which the therapy is being tested.
There, buntanetap was found to be safe when given once daily for 25 days at different doses. It also was better than the placebo at improving cognitive and motor skills, including speed of movement and coordination.