Phase 3 Trial for Buntanetap for Parkinson Disease Initiated

A phase 3 trial (NCT05357989) of buntanetap (Annovis Bio, Berwyn, PA) for Parkinson disease (PD) has been okayed by the Food and Drug Administration (FDA). People with early PD (Hoehn & Yahr [HY] scores 1-3) without PD-related psychosis or suicidal ideation will be eligible to enroll.

In a phase 2 trial (NCT04524351), individuals with PD (n=54) who were treated with buntanetap vs placebo, at day 25, had a dose-dependent mean 2.43-point (13.4%) improvement on the Unified Parkinson Disease Rating Scale (UPDRS) compared with baseline (P<.01). Statistically significant improvements on the Wechsler Assessment of Intelligence Scale (WAIS)-coding subtest with buntanetap vs placebo were also seen. 

"We are pleased that the FDA has approved our clinical trial design in early PD and called it a well-designed study. The positive FDA review affirms the company's path to securing approval for buntanetap to treat neurodegenerative diseases, including PD and AD, with longer treatment regimens," said Maria L. Maccecchini, PhD, founder, president, and chief executive officer of Annovis Bio. "With this FDA notice in hand, we are thrilled to start recruiting for the US clinical trial soon, expected later this summer."

Buntanetap, formerly called posiphen, is an orally administered small molecule that inhibits production of neurotoxic proteins that aggregate in neurodegenerative diseases.