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BIO RECEIVES POSITIVE RECOMMENDATION TO CONTINUE PHASE 2/3 TRIAL OF BUNTANETAP FOR alzheimer'S DISEASE PATIENTS FROM THE INDEPENDENT
DATA AND SAFETY MONITORING BOARD (DSMB)
PENNSYLVANIA -- October 30, 2023 (BUSINESS
WIRE)-- Annovis Bio, Inc. (NYSE: ANVS) ("Annovis"), announces the positive safety review by the Data
and Safety Monitoring Board (DSMB) for its phase 2/3 trial of buntanetap, a drug candidate for moderate to mild Alzheimer's Disease
(AD) patients. The DSMB recommended that Annovis continue the trial as originally designed.
The feedback from the DSMB was:
"The findings from the DSMB are
yet another positive affirmation for the direction we are taking in our research", said Maria Maccecchini, Ph.D., CEO of Annovis.
"We believe they are an important step along the way to potentially treating Alzheimer's Disease."
Annovis initiated the trial of buntanetap
in late March 2023. The DSMB safety evaluation was set to occur when 90 patients completed 6 weeks of dosing. When the DSMB was
convened on October 18, 2023, the data from a total of 107 patients was evaluated.
To date we have recruited a total of
281 patients out of the planned 320 patients; 76 patients have finished the study.
In our Alzheimer's Disease phase
2 trials, buntanetap was observed to improve cognition and speed of thinking. It was easily administered as a single pill taken once
daily and was generally well-tolerated.
About the Phase II/III Trial
This study is a phase 2/3, randomized,
double-blind, placebo-controlled trial investigating the efficacy, safety, and tolerability of buntanetap for mild to moderate AD 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 AD 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.
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.
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 safety or 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.