BERWYN, Penn., Nov. 8, 2022 /PRNewswire/ — Annovis Bio, Inc. (NYSE:ANVS) (“Annovis” or the “Company”), a clinical-stage drug platform company addressing neurodegenerative diseases, today announced third quarter financial results for the quarter ended September 30, 2022and reviewed recent accomplishments.
Maria L. Maccecchini, Ph.D., Founder, President, and CEO of Annovis, commented: “This quarter, we have made significant advances in the clinical development of buntanetap as we began to dose patients in our Phase 3 trial for early Parkinson’s Disease and received FDA authorization to proceed with a Phase 2/3 trial in moderate Alzheimer’s Disease. Additionally, we have seen that buntanetap works in numerous acute and chronic neurodegenerative conditions through its ability to inhibit multiple neurotoxic proteins, improve axonal transport and preserve nerve cell function in various neurodegenerative conditions. As a result, we have pursued and made significant strides this quarter in expanding our intellectual property portfolio as it relates to buntanetap and additional neurodegenerative conditions.”
Third Quarter Highlights and New Developments
- Receipt of Positive US Food and Drug Administration (FDA) Notice for Buntanetap Phase 3 Clinical Trial in Parkinson’s Disease (PD): The Company received notice from the FDA that the Phase 3 clinical study in early PD patients may proceed. The FDA accepted the final protocol and the clinical development plan, approved the use of the Company’s new large-scale batch of good manufacturing practice material, and found the chronic toxicology in rats and dogs safe and adequate to support long-term human studies. The Phase 3 trial is a randomized, double-blind, controlled trial investigating the efficacy, safety, and tolerability of buntanetap. The trial will enroll a total of 450 early PD patients to be treated with 10mg buntanetap, 20mg buntanetap or a placebo, on top of their standard of care, for six months. 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 bi omarkers…