BERWYN, PA — Annovis Bio, Inc. (NYSE: ANVS) announced that the first patient in a trial to test the effectiveness of buntanetap on early Parkinson’s Disease was recently dosed.
The Phase 3 trial is a study of how well buntanetap works, compared to a placebo, when given to 450 people with early PD for six months. The people will take 10mg or 20mg of buntanetap each day, along with their regular medication.
Movement Disorder Society-Sponsored Revision of the Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part II and III will be used as primary endpoints, while total MDS-UPDRS and Participant Global Impression of Change will be secondary endpoints. In addition, Wechsler Adult Intelligence Scale, plasma biomarkers and Mini-Mental State Examination will be evaluated as exploratory endpoints.
The Company previously reported results from its Phase 2a study of buntanetap in PD patients, which were treated with 5mg, 10mg, 20mg, 40mg or 80mg daily with no clinically significant adverse events. Additionally, treatment with buntanetap resulted in statistically significant improvement in motor function and its pharmacokinetics were found to be in line with levels measured earlier in humans, meeting both the primary and secondary endpoints.
Maria L. Maccecchini, Ph.D., Founder, President, and CEO 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 Parkinson’s Disease.”
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