Full Press Release Details
Annovis Bio Announces New Data from
Phase III Parkinson's Study Highlighting Improvements in Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and Cognition after
Treatment with Buntanetap
dose-dependent and statistically significant improvements in cognition in the overall enrolled PD population. Parkinson's patients
with substantial cognitive decline exhibited a very pronounced improvement.
statistical improvement in the MDS-UPDRS Part II, Part III, Part II+III and Total scores in Parkinson's patients
with a >3-year diagnosis.
the same statistical improvement in MDS-UPDRS Part II, Part III, Part II+III and Total scores in Parkinson's patients
with Postural Instability and Gait Difficulties (PIGD).
activity resulted in statistically significant improvements in all primary and secondary endpoints in the specified populations as
well as in cognition.
MALVERN, Pa., July 2, 2024 (GLOBE
NEWSWIRE) -- via IBN - Annovis Bio Inc. (NYSE: ANVS) ("Annovis" or the "Company"), a late-stage
clinical drug platform company pioneering transformative therapies for neurodegenerative disorders such as Alzheimer's Disease
(AD) and Parkinson's Disease (PD), today announced new data from its Phase III PD study demonstrating that buntanetap is safe and
effective in improving motor and non-motor activities and improving cognitive functions in patients with early Parkinson's disease.
These findings will be discussed in
more detail on today's webcast at 4:30 PM ET. Register here.
"We are very pleased to see improvements
in many of our patients over such a short course of treatment. These compelling data reinforce our commitment to advancing buntanetap
into a longer study, which will allow us not only to verify observed symptomatic improvements but also to explore buntanetap's
disease-modifying properties," said Maria Maccecchini, Ph.D., Founder, President and CEO of Annovis Bio.
Key Findings from the Study:
Buntanetap stops cognitive
decline in all enrolled patients (MMSE 20-30) and improves cognition in patients with mild dementia (MMSE 20-26).
in MMSE after treatment with 10mg or 20mg buntanetap compared to baseline and placebo.
Buntanetap improves motor
and non-motor PD-related functions in patients with a diagnosis of over 3 years.
in MDS-UPDRS after treatment with 10mg or 20mg buntanetap in patients with a PD diagnosis over 3 years compared to baseline and placebo.
Buntanetap improves motor
and non-motor PD-related functions in patients with Postural Instability and Gait Difficulty (PIGD).
in MDS-UPDRS after treatment with 10mg or 20mg buntanetap in patients with PIGD.
Safety Profile: Buntanetap maintained
a consistent safety profile across all participants, with no significant differences between early and advanced PD patients confirming
our previous AD data.
FDA and Endpoint Clarification:
Recent questions regarding the primary and secondary endpoints in MDS-UPDRS scores warrants additional explanation. Initially, Annovis
chose MDS-UPDRS Part II+III as the primary endpoint. However, based on FDA feedback, MDS-UPDRS Part II alone was deemed more
appropriate for reflecting clinically relevant changes (Goetz et al., 2023). Consequently, we adjusted our primary endpoint to
MDS-UPDRS Part II, with MDS-UPDRS Part III as a key secondary endpoint. Our results met both primary and secondary endpoints
in the specified subgroups.
Annovis Bio will host an investor webcast today at 4:30 PM ET to discuss these findings in detail. Investors and interested parties are
encouraged to register for the webcast in advance.
To register, please visit Webcast
Registration and complete the registration form.
Buntanetap (formerly known as Posiphen or ANVS401) targets neurodegeneration by inhibiting the formation of multiple neurotoxic proteins,
including amyloid beta, tau, alpha-synuclein, and TDP43. By improving synaptic transmission, axonal transport, and reducing neuroinflammation,
Buntanetap aims to reverse neurodegeneration in AD, PD, and other neurodegenerative diseases, thereby aiming to restore brain function
and improve the quality of life for patients.
in Malvern, Pennsylvania, Annovis Bio Inc. is dedicated to addressing neurodegeneration in diseases such as AD and PD. The company's
innovative approach targets multiple neurotoxic proteins, aiming to restore brain function and improve the quality of life for patients.
Interested investors and
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. These statements include, but are not limited to, the
Company's plans related to clinical trials. Forward-looking statements are based on current expectations and assumptions and are subject
to risks and uncertainties that could cause actual results to differ materially from those projected. Such risks and uncertainties include,
but are not limited to, those related to 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. Additional risk factors are
detailed in the Company's periodic filings with the SEC, including those listed in the "Risk Factors" section of the Company's
Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. All forward-looking statements in this press release are based
on information available to the Company as of the date of this release. The Company expressly disclaims any obligation to update or revise
its forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.
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