Annovis Bio, Inc. ANVS has initiated patient dosing in the Phase 3 clinical trial evaluating buntanetap in early Parkinson's Disease (PD).
The Phase 3 trial is designed to evaluate the efficacy, safety, and tolerability of buntanetap, will enroll upto 450 early PD patients.
The enrolled patients will be treated with 10mg buntanetap, 20mg buntanetap or a placebo, on top of their standard of care for six months.
The primary endpoint of the study will be Part II and III from the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), while total MDS-UPDRS and Participant Global Impression of Change will be secondary endpoints.
Further, Wechsler Adult Intelligence Scale, plasma biomarkers and Mini-Mental State Examination will be evaluated as exploratory endpoints.
Maria L. Maccecchini, Founder, President, and CEO, stated, "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 Parkinson's Disease."
In the Phase 2a study investigating buntanetap in PD patients, were treated with 5mg, 10mg, 20mg, 40mg or 80mg daily, with no clinically significant adverse events. The study met both primary and secondary endpoints.
Price Action : Annovis shares are trading around 12 percent higher at $11.97 on Wednesday during pre-market session.
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