Pharmather preparing phase 3 FDA package for ketamine

Mr. Fabio Chianelli reports PHARMATHER ADVANCES PHASE 3 FDA PACKAGE FOR KETAMINE IN LID-PARKINSON'S DISEASE Pharmather Holdings Ltd. has begun preparing its U.S. Food and Drug Administration briefing materials to discuss a phase 3 program for ketamine in levodopa-induced dyskinesia in Parkinson's disease, and prospective pharma partners are currently evaluating potential collaboration structures for the registrational program and commercialization. Key updates Pharmather is preparing a prephase 3 (Type B) FDA package to confirm the registrational study design -- including primary and key secondary end points -- along with the safety monitoring plan and other requirements for a 505(b)(2) new drug application in LID-PD, consistent with prior agency feedback that a single, well-controlled trial may be sufficient in appropriate settings. The planned phase 3 is designed to be derisked 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 1/2 work showed reductions in dyskinesias on the unified dyskinesia rating scale at multiple time points (51 per cent during infusion 2; 49 per cent at three weeks; and 41 per cent at three 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. Market opportunity As previously communicated, Pharmather estimates a U.S. treated market opportunity of approximately $750-million (U.S.) to $2.2-billion (U.S.) for an effective LID-PD therapy, informed by PD prevalence, LID incidence among levodopa-treated patients, and plausible treatment penetration and pricing assumptions. Planned near-term milestones: Fourth quarter 2025 and first quarter 2026: submit prephase 3 meeting request and briefing package; hold FDA meeting and receive minutes; First quarter and second quarter 2026: finalize phase 3 protocol (primary and key secondary end points, inclusion/exclusion, and statistical plan) per FDA feedback; First half 2026 onward: initiate phase 3 activities, contingent on FDA alignment and partnering/financing. "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," said Fabio Chianelli, chief executive officer of Pharmather. "Our strategy builds on the 505(b)(2) pathway, strong clinical signals and an FDA-reviewed CMC foundation. We believe a well-structured partnership can accelerate timelines, optimize commercial reach and unlock meaningful value for shareholders." About the phase 3 strategy 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, with an appropriate safety monitoring plan and treatment duration suited to a chronic condition. The planned efficacy approach will centre on dyskinesia severity and impact -- such as the Unified Dyskinesia Rating Scale -- while pain and mood will be assessed as exploratory domains given their relevance in Parkinson's disease and ketamine's potential influence. On the CMC front, the company intends to leverage validated analytical methods, specifications and stability programs derived from its FDA-reviewed manufacturing foundation to streamline phase 3 drug supply and reduce time and risk on the path to NDA submission. About Pharmather Holdings Ltd. Pharmather is a specialty life science company focused on unlocking the pharmaceutical potential of ketamine. We seek Safe Harbor.