PharmaTher Provides Update on Ketamine Program for LID-Parkinson's Disease

Executive Summary

• PharmaTher announced a Phase 3‑ready development plan for ketamine to treat levodopa‑induced dyskinesia (LID‑PD), leveraging its FDA‑reviewed 505(b)(2) CMC platform and existing patent protection through 2036.
• The company will seek a pre‑Phase 3 meeting with the FDA in Q4 2025–Q1 2026 to confirm the regulatory path, then finalize the pivotal protocol and aim to initiate the late‑stage study in early‑mid 2026, contingent on FDA alignment and financing/partnering.
• Market opportunity for a ketamine‑based LID‑PD therapy is estimated at US$0.75 billion–US$2.2 billion, based on prevalence data and projected pricing of $15k–$20k per treated patient annually.

Key Details

• Regulatory Strategy: 505(b)(2) pathway using existing ANDA‑approved ketamine CMC data to reduce risk, cost, and timelines; pre‑Phase 3 FDA meeting request slated for Q4 2025/Q1 2026.
• Clinical Plan: Single, well‑controlled Phase 3 trial targeting primary dyskinesia endpoints; secondary exploratory outcomes include pain and depression measures.
• CMC Leverage: Utilization of FDA‑reviewed ANDA analytical methods, specifications, and stability programs for the pivotal study and eventual commercial product.
• Patent Coverage: Exclusive rights to U.S. Patent No. 11,426,366 (expires May 2036) covering ketamine for motor disorder treatments, including Parkinson’s disease.
• Previous Clinical Evidence: Phase I/II data showed 51% reduction in Unified Dyskinesia Rating Scale scores during Infusion 2 (p = 0.003), with sustained reductions at 3 weeks (49%, p = 0.006) and 3 months (41%, p = 0.011); no post‑infusion adverse events reported.
• Market Size Estimate:
• U.S. Parkinson’s prevalence ≈ 1.1 million (projected 1.2 million by 2030).
• 30–40% develop LID → ~330k–440k patients.
• 15–25% of those treated → 50k–110k patients.
• Net price $15k–$20k per patient annually → $0.75 B–$2.2 B addressable market.
• Partnering & Capital Efficiency: Active discussions with potential pharmaceutical partners for acquisition or licensing; capital‑efficient advancement to pivotal stage emphasized.
• Upcoming Milestones:
• Q4 2025–Q1 2026: Submit and hold pre‑Phase 3 FDA meeting, receive minutes.
• Q1–Q2 2026: Finalize pivotal protocol based on FDA feedback.
• H1 2026 onward: Initiate late‑stage study (subject to FDA alignment and financing/partnering).

Notable Quotes

“This program not only addresses a major unmet need in Parkinson's disease but also highlights the scalability of our 505(b)(2) regulatory strategy,” – Fabio Chianelli, CEO
“The Phase 3‑ready ketamine program for LID‑Parkinson’s positions PharmaTher at an inflection point… one of the most promising late‑stage ketamine opportunities in neurology today.” – Fabio Chianelli, CEO

Materiality Assessment

Non-Material – Positive – The release provides forward‑looking strategic and market information without new financial results or definitive regulatory outcomes.