KetAImine™​

KetAImine™ is an AI-driven ketamine repurposing & discovery for high-value significant unmet medical needs. Turning decades of ketamine science and real-world evidence into regulator-aligned programs ready for focused, capital-efficient clinical development.
KetAImine™ underscores PharmaTher’s leadership in the ketamine space, fostering high-value partnerships that could drive revenue growth and expand market opportunities.

Why KetAImine™?
  • De-risked by design: Prioritizes indications and combinations that align with 505(b)(2) pathways and existing CMC know-how.
  • Speed to decision: Converts literature, real-world evidence (RWE), and safety data into ranked, testable programs.
  • Capital-efficient: Focuses on small, decision-enabling studies to move the right assets forward, faster.
  • Partner-ready: Outputs are structured for co-development, option/licensing, or regional partnerships.

What KetAImine™ Does?
KetAImine™ is PharmaTher’s AI platform that identifies, ranks, and designs ketamine-based programs—spanning new indications, formulations, combinations, and delivery technologies—with the objective of creating a scalable, regulator-aligned pipeline.

Core capabilities
  • Indication mining & triage: Maps mechanistic plausibility, unmet need, standard-of-care gaps, and trial feasibility.
  • Dose/formulation strategy: Recommends routes (e.g., SQ pump, LAI, intranasal, patch), regimens, and bridging logic.
  • Combination hypotheses: Screens for synergistic agents and sequence/maintenance strategies.
  • Evidence synthesis: Structures published trials, case series, and RWE for regulatory-grade rationale.
  • Risk & value scoring: Balances probability of technical/regulatory success with commercial potential.
  • Program design outputs: Generates draft Target Product Profiles (TPPs), study concepts, and partner data packs.

How It Works?
  1. Ingest: Peer-reviewed literature, clinical registries, post-marketing safety, protocol repositories, and internal datasets (including KetaVault™).
  2. Model: ML/NLP pipelines for mechanistic mapping, responder enrichment, dose-response inference, and safety signal stratification.
  3. Rank: Multi-factor scoring across efficacy rationale, regulatory feasibility (505(b)(2)), IP headroom, and market access.
  4. Design: Outputs trial-ready concepts (bridging/PK, Phase 2 signal, Phase 3 outline) and CMC leverage plans.
  5. Validate: Expert review panels and iterative evidence checks to finalize partner-ready packages.

Why PharmaTher?
  • Ketamine specialists: Deep domain expertise across neurological and pain disorders.
  • Regulatory alignment: Strategy anchored to 505(b)(2) pathways and existing chemistry-manufacturing-controls knowledge.
  • Data advantage: KetaVault™ provides a structured repository of ketamine-related evidence to inform KetAImine models.
  • Execution focus: Platform feeds directly into PharmaTher’s Clinical Development group for fast concept-to-clinic transitions.

Initial Program Focus
  • Neurological movement disorders (e.g., LID-Parkinson’s)
  • Neuropathic and centralized pain syndromes (e.g., CRPS)
  • Neurodegeneration and motor control (exploratory)
  • Adjunct/maintenance paradigms in psychiatric and pain care
Note: Areas of focus reflect platform-generated priorities and ongoing assessments; specific programs may evolve as new data emerge.

What Partners Get?
  • Program Blueprints: TPPs, indication rationale, patient population sizing, and competitive landscapes.
  • Regulatory Playbooks: Draft meeting questions, bridging strategies, and evidence maps supporting 505(b)(2).
  • Study Concepts: Protocol synopses for Phase 1b/2 signal detection and Phase 3 pathways.
  • CMC Leverage Plans: How to capitalize on existing know-how where applicable to reduce time and cost.
  • Deal-Ready Materials: Option/licensing structures, milestones frameworks, and regionalization paths.

KetAImine™ is a discovery and program-design platform. Any referenced candidates are investigational and have not been approved by the U.S. FDA or other regulators for the described indications. Forward-looking statements are subject to risks and uncertainties.

    Interested in partnering?

Connect With Us

PharmaTher Holdings Ltd.
82 Richmond Street East
Toronto, Ontario  Canada
M5C 1P1