Annovis Bio

Parkinson’s disease (PD) lacks neuroprotective/disease-modifying therapies (DMTs) and non-motor symptom treatments, with all marketed products being symptomatic. The PD drug development pipeline in 7MM focuses on addressing these unmet needs, with 66% of investigational agents targeting neuroprotective or DMT properties. Key opinion leaders (KOLs) express divided opinions on anti-alpha-synuclein therapies but agree on the need for DMT research. The pipeline also emphasizes therapies for non-motor symptoms, including PD-dementia and PD-psychosis, reflecting a shift towards slowing PD progression.

Annovis Bio received FDA clearance for Phase 3 trials of buntanetap for Alzheimer’s disease, targeting NDA submission within a year. Trials include a 6-month study for symptomatic effects and an 18-month study for disease-modifying potential, starting Q1 2025. No safety concerns were raised by the FDA.

Annovis Bio received FDA clearance for Phase 3 trials of buntanetap for Alzheimer’s disease, targeting NDA submission within a year based on a 6-month trial. The FDA raised no safety concerns, supporting the drug’s new crystal form. Trials aim to assess symptomatic effects and long-term benefits.

Annovis Bio to present Buntanetap's Alzheimer's research at CTAD 2024 in Madrid, with posters on efficacy in early AD and biomarker data.

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Annovis Bio Inc. announced FDA clearance for phase 3 studies of buntanetap, its therapy for early Alzheimer’s disease, based on phase 2/3 data showing symptomatic improvement. The phase 3 program includes a 6-month trial for symptomatic effects and an 18-month trial for disease-modifying effects. The FDA raised no safety concerns and approved the new crystal form of buntanetap. Annovis aims to initiate trials early next year for expedited NDA submission.

Annovis Bio Inc. announced FDA clearance for Phase 3 studies of buntanetap, based on Phase 2/3 data showing symptomatic improvement in early Alzheimer's patients. The Phase 3 program will include two trials: a 6-month study for symptomatic effects and an 18-month study for disease-modifying effects. The FDA raised no safety concerns, allowing development to proceed with the new crystal form of buntanetap.

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Annovis Bio Inc. announced FDA clearance for pivotal Phase 3 studies of buntanetap, based on Phase 2/3 data showing symptomatic improvement in early Alzheimer’s patients. The Phase 3 program includes a 6-month study for symptomatic effects and an 18-month study for potential disease-modifying effects, aiming for NDA filings.