Annovis Bio Announces Completion of Phase III Parkinson's Disease Treatment Enrollment at Record Pace
BERWYN, Pa., June 8, 2023 /PRNewswire/ -- Annovis Bio, Inc. (NYSE: ANVS), a clinical-stage drug platform company addressing neurodegenerative diseases such as Alzheimer's (AD) and Parkinson's disease (PD) and developing novel and transformative therapies, announced that its PD phase III study of its lead compound buntanetap has reached full enrollment in a record nine months after it began.
Since the first patient was dosed in late August 2022, over 640 patients were screened and a total of 520 patients enrolled in record time with 67 sites (43 in the United States and 24 in the European Union).
The phase III trial is a randomized, double-blind, placebo-controlled trial investigating the efficacy, safety, and tolerability of buntanetap for early PD patients on top of their standard of care. Buntanetap (formerly known as Posiphen or ANVS401) attacks neurodegeneration by reducing multiple neurotoxic proteins, therefore improving synaptic transmission and axonal transport, the information highway of the nerve cell, which has been shown to be the cause of nerve cell degeneration and ultimately death. Unlike other PD drugs in development which attempt to remove only one toxic protein, buntanetap inhibits several toxic proteins before they can form, thereby preventing the formation of all the major neurotoxic proteins responsible for PD and AD.
By lowering levels of neurotoxic proteins, buntanetap improves axonal transport, lowers inflammation, fosters the health of nerve cells, and improves motor and cognitive dysfunction.
The record enrollment and low drop-out rate are believed to be due to several factors: In phase I/II the drug showed improvements in body and motor function, it requires taking only one pill a day, and it is safe and well tolerated. The study is expected to conclude in November with top-line assessment data available by the end of the year.
"The Parkinson's community is extremely well-informed and connected," said Annovis' founder, president and CEO, Maria Maccecchini, Ph.D. ("Dr. Maria"). "When they learned of our innovative and patient-focused approach showing early therapeutic potential they wanted to be involved in making an impact." The ramifications of such drug therapy could be transformative for all neurodegenerative diseases, according to Dr. Maria.
About Annovis Bio, Inc.
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SOURCE Annovis Bio
Company Codes: NYSE:ANVS