Annovis Bio Receives Excellent Safety Rating and Positive Recommendation to Continue Phase III Trial of Buntanetap for Parkinson’s Disease Patients from the Independent Data and Safety Monitoring Board (DSMB)
June 20 2023 - 12:05PM
Business Wire
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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Investor Contact: Laura Feragen Jacobson Strategic Health
267-262-4309 laura@jacobsonstrategic.com
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