October 16, 2025.
Toronto, Ontario — October 16, 2025 — Leads & Copy — PharmaTher Holdings Ltd. has begun preparing its U.S. Food and Drug Administration (FDA) briefing materials to discuss a Phase 3 program for ketamine in levodopa-induced dyskinesia in Parkinson’s disease (LID-PD). The company also announced that prospective pharma partners are currently evaluating potential collaboration structures for the registrational program and commercialization.
PharmaTher is preparing a Pre-Phase 3 (Type B) FDA package to confirm the registrational study design, including primary and key secondary endpoints, along with the safety monitoring plan and other requirements for a 505(b)(2) NDA in LID-PD. The planned Phase 3 is designed to be de-risked by leveraging the 505(b)(2) pathway and existing clinical evidence, PharmaTher’s FDA-reviewed CMC foundation, and intellectual-property coverage through 2036 (U.S. Patent No. 11,426,366).
Prior Phase I/II work showed reductions in dyskinesias on the UDysRS at multiple time points (51% during Infusion 2; 49% at 3 weeks; 41% at 3 months), with ketamine generally safe and well tolerated. These data will inform the Phase 3 design. In parallel, the Company is in discussions with potential partners covering potential co-development and licensing.
PharmaTher estimates a U.S. treated market opportunity of approximately US$0.75-$2.2 billion for an effective LID-PD therapy.
Planned near-term milestones include submitting a Pre-Phase 3 meeting request and briefing package in Q4 2025 – Q1 2026, finalizing the Phase 3 protocol in Q1 – Q2 2026, and initiating Phase 3 activities in 1H 2026 onward, contingent on FDA alignment and partnering/financing.
Fabio Chianelli, Chief Executive Officer of PharmaTher, stated that the company is moving from planning to execution, securing FDA alignment for a Phase 3 path while also advancing active discussions with multiple partners. He added that a well-structured partnership can accelerate timelines, optimize commercial reach, and unlock meaningful value for shareholders.
PharmaTher’s Phase 3 strategy seeks FDA agreement that a single, well-controlled Phase 3 study conducted under the 505(b)(2) pathway could support an NDA. The planned efficacy approach will center on dyskinesia severity and impact, while pain and mood will be assessed as exploratory domains.
Contact:
Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.com
Source: PharmaTher
