First Participant Dosed with Buntanetap in Phase 3 Trial for Early Parkinson Disease

In a phase 3 clinical trial for early Parkinson disease (PD) treatment, the first participant was dosed with buntanetap (ANVS401; Annovis, Berwyn, PA). Planned enrollment is 450 participants with early PD who will be randomly assigned to receive 10 or 20 mg buntanetap or placebo, on top of their standard of care treatment for 6 months.

Clinical improvement will be measured with the Movement Disorder Society-Sponsored Revision of the Unified PD Rating Scale (MDS-UPDRS) part 2 and 3, Participant Global Impression of Change (PGIC), Wechsler Adult Intelligence Scale (WAIS), plasma biomarkers, and the Mini-Mental State Examination (MMSE).

There were no clinically significant adverse events in a phase 2a trial when participants were treated with 5  to  80 mg buntanetap daily. There were statistically significant improvements in motor function, and pharmacokinetics were found to be in line with levels measured.

Maria L. Maccecchini, PhD, founder, president, and chief executive officer of Annovis Bio said: "Buntanetap has shown promising preliminary safety data in all clinical work to date. Just as encouraging is the significant improvement in speed of movement, motor function and cognitive function observed in early to moderate PD patients treated with buntanetap in the phase 2a trial. Now, as we officially advance buntanetap into a phase 3 trial, with a longer treatment duration and a dose range shown to be efficacious in early studies, we are one step closer to delivering a solution that can transform the lives of patients with PD."