BERWYN, Pa., Dec. 05, 2023 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS), a clinical-stage drug platform company developing novel therapies for neurodegenerative diseases today announced last patient last visit in the phase III study of its lead candidate buntanetap in patients with early Parkinson’s disease (PD). Topline data results are expected in January 2024.
"We are pleased to share the completion of our Parkinson's study which marks a significant step forward in our ongoing mission to bring new therapies for those affected by this challenging neurodegenerative disease," said Maria Maccecchini, Ph.D., Founder, President, and CEO of Annovis. “The study saw a substantial level of participation, with patients enrolling at a record pace."
"We extend our appreciation to all participants and collaborators whose contributions enabled efficient and timely completion of the study," said Melissa Gaines, Senior Vice President, Clinical Operations. “Our team now shifts its focus to diligently cleaning and analyzing the data to meet our goal of sharing the topline results early next year."
About the Phase III Trial
This study is a phase III, 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. Patients were treated with buntanetap (10 mg or 20 mg) or placebo for 6 months. The study was initiated in August 2022 with a record pace of full enrollment in just nine months and a total of 616 screened, 523 randomized and 471 completed patients across 67 sites (43 in the United States and 24 in the European Union). Screen failure (15%) and drop out (9.9%) rates were below projections.
Buntanetap (formerly known as Posiphen or ANVS401) attacks neurodegeneration by reducing multiple neurotoxic proteins, thereby improving synaptic transmission and axonal transport, which is the information highway of the nerve cell. Dysfunction of synaptic transmission and axonal transport 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.
About Annovis Bio, Inc.
Headquartered in Berwyn, Pennsylvania, Annovis Bio, Inc. is a clinical-stage, drug platform company addressing neurodegeneration, such as Alzheimer’s Disease (AD), Parkinson’s Disease (PD), and other chronic neurodegenerative diseases. It is believed to be the only company developing a drug for both AD and PD designed to inhibit more than one neurotoxic protein to restore axonal and synaptic activity. By improving brain function, the company’s goal is to treat memory loss and dementia associated with AD as well as body and brain dysfunction associated with PD. For more information on Annovis Bio, please visit the Company's website www.annovisbio.com and follow us on LinkedIn and Twitter.
This press release contains "forward-looking" statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The Company advises caution in reliance on forward-looking statements. Forward-looking statements include, without limitation, the Company's plans related to clinical trials. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results to differ materially from those implied by forward-looking statements, including regarding patient enrollment, the effectiveness of Buntanetap and the timing, effectiveness, and anticipated results of the Company's clinical trials evaluating the efficacy, safety and tolerability of buntanetap. See also additional risk factors set forth in the Company's periodic filings with the SEC, including, but not limited to, those risks and uncertainties listed in the section entitled "Risk Factors," in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC. All forward-looking statements in this press release are based on information available to the Company as of the date of this filing. The Company expressly disclaims any obligation to update or alter its forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
Maria Maccecchini, Ph.D.