PharmaTher Announces KetAImine(TM) - AI Discovery Platform to Expand the Ketamine Portfolio, Enable Earlier Partnering, and Fast-Track 505(b)(2) NDA Filings

Executive Summary

• PharmaTher announced the launch of KetAImine™, a proprietary AI‑driven ketamine repurposing and discovery platform within its new Digital Health AI division.
• The platform integrates real‑world data, literature mining, and the company’s FDA‑approved ketamine ANDA CMC to generate de‑risked indication candidates and combination therapy hypotheses for 505(b)(2) NDA pathways.
• Near‑term milestones include delivering a shortlist of 6–8 priority programs by Q4 2025, selecting two lead programs for protocol finalization in Q1 2026, and securing at least three data‑access or co‑development collaborations during H1 2026.

Key Details

• KetAImine™ Platform – Uses domain‑tuned natural language processing and foundation models to structure clinical text into a ketamine‑specific ontology, estimate real‑world effects, identify responder subpopulations, and propose synergistic co‑therapies.
• Digital Health AI Division Components – Comprises KetAImine™ and KetaVault™, the latter housing disease‑area datasets (Parkinson’s LID‑PD, ALS, CRPS), formulation/readout files (microneedle patch, subcutaneous wearable pump), and the FDA‑approved ketamine ANDA CMC backbone.
• Therapeutic Areas Targeted – Psychiatry, CNS disorders, peri‑operative care, inflammatory conditions, addiction, supportive oncology, rare diseases, and other indications where ketamine mechanisms may be beneficial.
• Milestones (6–12 months)
• Q4 2025: Complete a shortlist of 6–8 priority programs with technical and regulatory success probability assessments and draft study concepts.
• Q1 2026: Down‑select two lead indication or combination programs for protocol finalization aimed at 505(b)(2) bridging or Phase 2/3 studies; initiate FDA interactions.
• H1 2026: Announce ≥ 3 data‑access and/or co‑development collaborations.
• 2026 (throughout): File new IP covering dosing paradigms, delivery/formulation strategies, and combination methods of use.
• Strategic Significance – Leverages the validated ketamine ANDA CMC to underpin multiple future NDAs via the 505(b)(2) pathway, creating a capital‑efficient development model that generates “shots on goal” across monotherapy and combination programs while expanding partnering opportunities.

Notable Quotes

“Our Digital Health AI division will be a force‑multiplier,” said Fabio Chianelli, Founder and CEO of PharmaTher. “With KetAImine™, we aim to unite real‑world data, published evidence, our proprietary ketamine‑based clinical findings…to compress timelines, reduce risk, and generate protectable IP.”