- Phase 3 program targeting a potential US$2.2B U.S. market opportunity
- 505(b)(2) regulatory path leveraging prior human data to reduce risk, cost, and time
- FDA-reviewed CMC package validated through prior ANDA approval
- Patent coverage to 2036 for ketamine in Parkinson's and related motor disorders
- Active pharmaceutical partnering discussions
- Upcoming catalysts (Q4 2025 - Q2 2026): FDA meeting, pivotal study readiness, pharma partnership
Toronto, Ontario--(Newsfile Corp. - October 8, 2025) - PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) (the "Company" or "PharmaTher"), a specialty pharmaceutical company focused on unlocking the pharmaceutical potential of ketamine, today announced an update regarding its initiative to develop ketamine as a treatment for levodopa-induced dyskinesia (LID-PD) in patients with Parkinson's disease.
PharmaTher's objective is to continue the development of its ketamine program for LID-PD via the 505(b)(2) regulatory pathway, leveraging existing scientific and clinical evidence together with the Company's FDA-reviewed Chemistry, Manufacturing and Controls (CMC) foundation to reduce development risk, cost and timelines. The Company is preparing for a Phase 3, well-controlled clinical study designed to evaluate efficacy and safety in support of a potential New Drug Application (NDA), subject to FDA feedback.
Four-Pillar Strategy
Regulatory alignment. PharmaTher intends to request a Pre-Phase 3 meeting with the FDA to obtain clarity on a Phase 3-enabling path and confirm key components of a registrational plan for LID-PD.
Clinical plan. The Company plans to pursue FDA acceptance for a single, well-controlled Phase 3 study to support NDA submission. The protocol will include safety monitoring aligned with the ketamine class and will assess pain and depression as exploratory secondary outcomes, alongside dyskinesia-focused primary endpoints.
CMC leverage. PharmaTher will utilize the work completed for its FDA-reviewed Ketamine ANDA to streamline analytical methods, specifications and stability programs for intended clinical and commercial presentations under 505(b)(2).
Partnering & capital efficiency. The Company is engaged in active discussions with prospective pharmaceutical partners that could acquire or license the program, supporting a capital-efficient advancement to and through pivotal development.
Ketamine's Value Proposition in LID-PD
Mechanistic rationale. Excessive glutamatergic/NMDA signaling is implicated in dyskinesia. The only FDA-approved LID therapy (amantadine ER) is NMDA-based, validating the target class. Ketamine, a non-competitive NMDA receptor antagonist with additional receptor-level actions, therefore has a strong biological rationale for evaluation in LID-PD.
Clinical evidence. In a previously reported Phase I/II study, ketamine was safe and well-tolerated. All treated subjects experienced reductions in dyskinesias, as measured by the Unified Dyskinesia Rating Scale (UDysRS): 51% from baseline during Infusion 2 (p = 0.003), 49% at 3 weeks (p = 0.006), and 41% at 3 months (p = 0.011). No adverse events were reported post-infusion.
Time & cost advantages. Leveraging PharmaTher's FDA-validated CMC platform from the ANDA program is expected to compress development timelines and costs for the NDA submission by streamlining manufacturing, quality and regulatory activities.
Patent Coverage. PharmaTher has exclusive rights to US Patent No: 11,426,366 (expires May 2036), titled "Compositions and Methods for Treating Motor Disorders," which includes claims intended to cover ketamine in the potential treatment of Parkinson's Disease and motor disorders that cause involuntary or uncontrollable movement or actions of the body.
Market Opportunity
Approximately 1.1 million individuals in the United States are currently living with Parkinson's Disease, with an estimated 90,000 new diagnoses occurring annually. Projections indicate that the prevalence of PD will reach approximately 1.2 million by the year 2030 in the U.S.1 Globally, it is estimated that the number of Parkinson's cases will grow to more than 25 million by 20502. Published literature indicates that approximately 30-40% of patients receiving levodopa treatment develop dyskinesia within 4-6 years. This prevalence tends to increase, reaching approximately 50-60% or higher, with prolonged exposure to the medication3.
There could be a significant market opportunity for a ketamine-based treatment in LID-Parkinson's Disease, with an implied treated market estimated between US$0.75 billion and US$2.2 billion. This is based on approximately 1.1 million Parkinson's Disease patients, 30-40% of whom develop clinically meaningful LID (330,000-440,000), 15-25% of these patients are treated (50,000-110,000), at a net price of $15,000-$20,000 per treated patient annually.
Strategic Significance
PharmaTher's LID-PD program represents a high-value clinical and commercial opportunity in a validated treatment category with proven reimbursement viability. With proprietary clinical data, patent protection to 2036, and an FDA-reviewed CMC foundation, the Company is positioned to advance a capital-efficient, late-stage program with potential for strategic licensing or acquisition.
PharmaTher believes that its progress in LID-PD, together with its broader ketamine franchise, offers multiple near-term catalysts to unlock shareholder value - including FDA feedback on the Phase 3 pathway, potential partnership developments, and expansion opportunities in other neurological and motor disorders.
"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," said Fabio Chianelli, Chief Executive Officer of PharmaTher. "Each milestone we reach with ketamine for LID brings us closer to unlocking broader value in our ketamine platform across multiple indications."
Anticipated Near-Term Milestones
Q4 2025 - Q1 2026: Submit Pre-Phase 3 FDA meeting request and briefing package; hold meeting and receive minutes (timing subject to Agency scheduling).
Q1 - Q2 2026: Finalize pivotal protocol (endpoints, inclusion/exclusion, statistical plan) based on FDA feedback.
1H 2026 and onward: Initiate late-stage study, contingent on FDA alignment and financing/partnering; provide periodic updates on enrollment, safety and business development activities.
Fabio Chianelli, Chief Executive Officer of PharmaTher, concluded:
"The Phase 3-ready ketamine program for LID-Parkinson's positions PharmaTher at an inflection point. With a de-risked regulatory path, a validated manufacturing foundation, and a multi-billion-dollar addressable market, this program represents one of the most promising late-stage ketamine opportunities in neurology today. Our goal is to create meaningful value for both patients and shareholders as we advance toward FDA alignment, pivotal initiation, and strategic partnership in 2026."
About PharmaTher
PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is focused on unlocking the pharmaceutical potential of ketamine for mental health, pain, and neurological disorders. For more information, visit PharmaTher.com.
For more information about PharmaTher, please contact:
Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com
Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.
Cautionary and Forward-Looking Statements
Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. There can be no assurance that the Company will proceed with the clinical development towards a Phase 3 clinical study and that the FDA will support any potential request for an expedited path to approval. These risks include, among others, the commercial performance of the ANDA product, FDA acceptance of the regulatory plan, Phase 3 ready study, clinical development, CMC package, regulatory approvals, market acceptance and opportunities, competition, market size, the Company program being acquired or licensed, and the Company's estimates of potential sales in PD-LID. Readers are cautioned not to place undue reliance on forward-looking statements. PharmaTher disclaims any obligation to update or revise forward-looking statements except as required by law. In addition, this press release contains cautionary and forward-looking statements and information within the meaning of applicable Canadian securities legislation. These relate to future events or future performance. The use of any of the words "aim", "anticipate", "before", "believe", "closer", "confident", "could", "eligible", "enable", "ensure", "estimated", "expect", "intend", "lead", "leverage", "makes", "may", "mitigate", "plan", "position", "potential", "prior", "promise", "projected", "proposed", "provide", "ready", "significant", "strong", "toward", "will", "would", and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the "Company") current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption "Risk Factors" in the Company's management's discussion and analysis for the year ended May 31, 2025, dated September 26, 2025, which is available on the Company's profile at www.sedarplus.ca.
This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.
References:
- https://www.parkinson.org/understanding-parkinsons/statistics
- https://www.bmj.com/content/388/bmj-2024-080952
- https://pmc.ncbi.nlm.nih.gov/articles/PMC5586110/
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/269587
SOURCE: PharmaTher Holdings Ltd.
