PharmaTher Advances Phase 3 FDA Package for Ketamine in LID-Parkinson's Disease

Executive Summary

• PharmaTher Holdings announced it is preparing a Pre‑Phase 3 (Type B) FDA briefing package for a ketamine Phase 3 program targeting levodopa‑induced dyskinesia in Parkinson’s disease (LID‑PD).
• The company is actively discussing co‑development and licensing structures with multiple prospective pharmaceutical partners.
• Near‑term milestones include submitting a Pre‑Phase 3 meeting request (Q4 2025–Q1 2026), finalizing the Phase 3 protocol (Q1–Q2 2026), and potentially initiating Phase 3 activities in 1H 2026, contingent on FDA alignment and partnership/financing.

Key Details

• Regulatory Pathway: Pursuing a 505(b)(2) NDA route; preparing a Type B pre‑Phase 3 package covering study design, primary/secondary endpoints, safety monitoring plan, and CMC considerations.
• Clinical Rationale: Prior Phase I/II data showed ketamine reduced dyskinesia severity on the Unified Dyskinesia Rating Scale (UDysRS) – 51% reduction during Infusion 2, 49% at 3 weeks, and 41% at 3 months – with a favorable safety/tolerability profile.
• Intellectual Property: U.S. Patent No. 11,426,366 provides protection through 2036 for the ketamine formulation.
• Market Opportunity Estimate: U.S. treated market sized between US$0.75 billion and US$2.2 billion for an effective LID‑PD therapy, based on prevalence, incidence, penetration, and pricing assumptions.
• Partnering Strategy: Engaging multiple potential pharma partners to explore co‑development, licensing, and commercialization structures; aims to accelerate timelines and broaden commercial reach.
• Planned Milestones:
• Q4 2025 – Q1 2026: Submit Pre‑Phase 3 meeting request & briefing package; hold FDA meeting and receive minutes.
• Q1 – Q2 2026: Finalize Phase 3 protocol (endpoints, inclusion/exclusion criteria, statistical plan) per FDA feedback.
• 1H 2026 onward: Initiate Phase 3 trial activities, subject to FDA alignment and secured partnership/financing.

Notable Quotes

“We're moving from planning to execution—securing FDA alignment for a Phase 3 path while also advancing active discussions with multiple partners who recognize the potential for ketamine in LID‑Parkinson's,” – Fabio Chianelli, CEO.