The drug is proving to be safe and well-tolerated
Annovis Bio, Inc. (NYSE: ANVS), announces the positive safety review by the Data and Safety Monitoring Board (DSMB) for its phase III trial of buntanetap, a drug for early Parkinson’s Disease (PD) patients. The DSMB recommended that Annovis Bio continue the trial as originally designed.
The feedback from the DSMB was:
- no drug-related SAEs (Serious Adverse Events)
- each AE (Adverse Event): less than 2 percent
- very low dropout rate: 6 percent
- enrolled well ahead of expected timeline: 9 months to enroll 523 patients.
“It’s exciting that our drug is proving to be safe, well-tolerated, is easily administered as a once-a-day pill and has therapeutic potential, all of which have important implications for the transformative treatment of all neurodegenerative diseases,” said Maria Maccecchini, Ph.D., CEO of Annovis.
Annovis initiated the trial of buntanetap in late August 2022. Over 640 patients were screened and 523 were enrolled in just nine months, well ahead of typical enrollment speed. Patients were treated at a total of 67 sites (43 US and 24 EU). The DSMB safety evaluation was set to occur when 150 patients completed two months of treatment. By that time, there were already a total of 414 patients enrolled worldwide, with only a six percent drop-out rate, which is significantly below expectations. No serious drug-related adverse events have been reported to date and no single adverse event occurring in more than two percent of the enrolled study population.
The planned enrollment has been reached and based on this DSMB endorsement, Annovis is excited to announce that topline results are expected by the end of 2023.
In the Parkinson’s Disease phase II trials, buntanetap was shown to improve body and motor function. It is easily administered as a single pill taken once daily and is well-tolerated. These factors contributed to the accelerated enrollment and low drop-out rate.
As of June 9, 2023, the trial has completed enrollment and is expected to conclude in November, with top-line data available by the end of the 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. 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, Pa., 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 information about the company’s clinical trials and patents, visit anovisbio.com, and follow the company on LinkedIn and Twitter.
Forward-Looking Statements
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.
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