Update on Annovis Buntanetap

[Imaparky]

Update from Annovis

We are excited to announce two significant advances in our progress in developing a novel therapy for Parksinon’s, Alzheimer’s, and other neurodegenerative diseases.

Annovis Files a Groundbreaking Composition of Matter Patent

Annovis Bio has developed a new crystalline form of buntanetap (ANVS402) and we have submitted a provisional new composition of matter patent to the U.S. Patent and Trademark Office. ANVS402 offers significant advantages over the previous, less structured form, including better stability, higher purity, and longer half-life, improving buntanetap’s effectiveness. The composition of matter patent is crucial for any pharmaceutical company creating a new drug, providing protection for the compound and its uses for a 20-year term if approved. (Note: ANVS402 is expected to replace buntanetap in future Parkinson’s and Alzheimer’s disease clinical trials after completion of a bridging study in early 2024.)

DSMB Gives Annovis Positive Recommendation to Continue Phase III Trial of Buntanetap

Annovis Bio's phase III trial for buntanetap received a positive safety recommendation review from the Data and Safety Monitoring Board (DSMB) and recommended that we continue the trial as originally designed. The DSMB noted this favorable feedback:

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.

Now that the planned enrollment has been reached, based on the DSMB endorsement, we can expect topline results by the end of 2023. We are enthusiastic that our drug is proving to be safe, well-tolerated, 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.

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