Annovis Bio Announces Positive FDA Notice For Buntanetap Phase 3 Clinical Trial In Parkinson’s Disease

Annovis Bio

BERWYN, PA — Annovis Bio, Inc. (NYSE: ANVS) announced that the Company recently received notice from the FDA that the Phase 3 clinical study in early Parkinson’s patients may proceed. The FDA accepted the final protocol and the clinical development plan, approved the use of the Company’s new large-scale batch of good manufacturing practice material, and found the chronic toxicology in rats and dogs safe and adequate to support long-term human studies lasting decades compared to the previous restriction of one month.

Following a successful Type B meeting for the continued development of buntanetap in Parkinson’s disease with the FDA earlier this year, the Company requested consideration from the FDA on amending the accepted development plan, finalizing the protocol for the Phase 3 study, and proceeding with longer duration clinical trials. The Company submitted all the safety data in mice, rats, dogs and over 200 humans, the chemistry, manufacturing, and controls package for the new large-scale batch, and all the data accumulated over the years for the Company’s Alzheimer’s disease program that also pertained to Parkinson’s disease program.

PROTOCOL TITLE

A 6-month prospective, randomized, double-blind, placebo-controlled
clinical trial investigating the efficacy, safety, and tolerability of two
different doses of buntanetap or placebo in patients with early Parkinson’s disease

STUDY DESIGN

Placebo-controlled and double-blind in 100 sites in the US and EU

INVESTIGATIONAL PRODUCT

Buntanetap 10 mg, 20 mg, or placebo capsules, taken orally once a day for 6 months

SUMMARY OF KEY ELIGIBILITY CRITERIA

Diagnosis of idiopathic PD, Age 40 to 85, MMSE 22-30,                            
Hoehn & Yahr = 1,2,3 and OFF-state < 2hrs per day

PRIMARY OUTCOME MEASURES

MDS-UPDRS Part II+III

SECONDARY OUTCOME MEASURES

•  Total MDS-UPDRS score

•  Participant Global Impression of Change (PGIC)

•  Clinical Global Impression of Severity of illness (CGIS)

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“We are pleased that the FDA has approved our clinical trial design in early PD patients and called it a well-designed study. The positive FDA review affirms the Company’s path to securing approval for buntanetap to treat neurodegenerative diseases, including Parkinson’s and Alzheimer’s diseases, with longer treatment regimens,” said Maria L. Maccecchini, Ph.D., Founder, President, and CEO of Annovis Bio. “With this FDA notice in hand, we are thrilled to start recruiting for the US clinical trial soon, expected later this summer.”

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