PharmaTher Provides Update on Ketamine Program for LID-Parkinson's Disease
PharmaTher (OTCQB: PHRRF) announced progress on a Phase 3 development program to evaluate ketamine for levodopa-induced dyskinesia (LID) in Parkinson's disease via a 505(b)(2) pathway. Key assets include an FDA-reviewed CMC foundation, Phase I/II clinical data showing UDysRS reductions (51% infusion 2; 49% at 3 weeks; 41% at 3 months) and US patent protection to May 2036. The company targets a potential US$0.75–2.2B treated-market and is pursuing a Pre-Phase 3 FDA meeting (Q4 2025–Q1 2026), pivotal protocol finalization (Q1–Q2 2026) and partnering discussions to support a late-stage trial in 1H 2026, subject to FDA alignment and financing.
PharmaTher (OTCQB: PHRRF) ha annunciato progressi in un programma di sviluppo di fase 3 per valutare la ketamina per la diskinesia indotta dal levodopa (LID) nella malattia di Parkinson tramite una via 505(b)(2). Risorse chiave includono una fondazione CMC revisionata dalla FDA, dati clinici di fase I/II che mostrano riduzioni UDysRS (51% infusione 2; 49% a 3 settimane; 41% a 3 mesi) e protezione brevettuale negli Stati Uniti fino a maggio 2036. La società punta a un mercato trattato USA potenziale tra US$0,75 e 2,2 miliardi ed è in cerca di un incontro Pre-Phase 3 con la FDA (Q4 2025–Q1 2026), finalizzazione del protocollo principale (Q1–Q2 2026) e discussioni di partenariato per supportare un trial di fase avanzata nella prima metà del 2026, soggetto al confronto con la FDA e al finanziamento.
PharmaTher (OTCQB: PHRRF) anunció avances en un programa de desarrollo de fase 3 para evaluar la ketamina para la discinesia inducida por levodopa (LID) en la enfermedad de Parkinson mediante una vía 505(b)(2). Los activos clave incluyen una bases de CMC revisada por la FDA, datos clínicos de fase I/II que muestran reducciones UDysRS (51% infusión 2; 49% a las 3 semanas; 41% a los 3 meses) y protección de patentes en EE. UU. hasta mayo de 2036. La empresa apunta a un mercado tratado en EE. UU. potencial de US$0,75–2,2 mil millones y está buscando una reunión Pre-Phase 3 con la FDA (Q4 2025–Q1 2026), la finalización del protocolo pivot (Q1–Q2 2026) y discusiones de partenariado para apoyar un ensayo de última fase en la 1H 2026, sujeto al alineamiento con la FDA y al financiamiento.
PharmaTher (OTCQB: PHRRF)은 파킨슨병에서 레보도파 유래 운동 이상증(LID)을 평가하기 위한 3상 개발 프로그램의 진행을 발표했습니다. 경로는 505(b)(2)입니다. 주요 자산으로는 FDA 심사 CMC 기반, UDysRS 감소를 보여주는 1/2상 임상 데이터(주입 2에서 51%; 3주에서 49%; 3개월에서 41%)와 미국 특허 만료일 2036년 5월까지의 보호가 포함됩니다. 회사는 미국 내 잠재 치료시장 규모를 US$0.75–2.2B로 보고하며, 2025년 4분기~2026년 1분기에 FDA 선행 Phase 3 회의, 2026년 1Q–2Q에 중요한 프로토콜 확정, 2026년 상반기에 2상 이후 시험을 지원하기 위한 파트너십 논의를 추진하고 있으며, 이는 FDA의 조율 및 자금 조달 여부에 달려 있습니다.
PharmaTher (OTCQB: PHRRF) a annoncé des avancées dans un programme de développement de phase 3 pour évaluer la kétamine pour la diskynésie induite par la lévodopa (LID) dans la maladie de Parkinson via une voie 505(b)(2). Les actifs clés incluent une base CMC approuvée par la FDA, des données cliniques de phase I/II montrant des réductions UDysRS (51% infusion 2; 49% à 3 semaines; 41% à 3 mois) et une protection par brevet américain jusqu’en mai 2036. La société vise un marché traité potentiel aux États-Unis de US$0,75–2,2 milliards et poursuit une réunion pré-Phase 3 avec la FDA (Q4 2025–Q1 2026), la finalisation du protocole pivot (Q1–Q2 2026) et des discussions de partenariat pour soutenir un essai de phase tardive au 1er semestre 2026, sous réserve de l’alignement avec la FDA et du financement.
PharmaTher (OTCQB: PHRRF) gab Fortschritte bei einem Phase-3-Entwicklungsprogramm bekannt, um Ketamin zur levodopa-induzierten Dyskinesie (LID) bei Parkinson mittels eines 505(b)(2)-Weges zu bewerten. Zu den wichtigsten Vermögenswerten gehören eine FDA-überprüfte CMC-Grundlage, Phase-I/II-Klinikdaten, die UDysRS-Reduzierungen zeigen (51% Infusion 2; 49% nach 3 Wochen; 41% nach 3 Monaten) und US-Patentschutz bis Mai 2036. Das Unternehmen zielt auf einen potenziellen behandelten Markt in den USA von US$0,75–2,2 Mrd. und verfolgt ein Pre-Phase-3-FDA-Treffen (Q4 2025–Q1 2026), die Finalisierung des pivotalen Protokolls (Q1–Q2 2026) und Partnerschaftsdiskussionen, um eine späte Phase-Studie in der ersten Hälfte 2026 zu unterstützen, vorbehaltlich FDA-Abstimmung und Finanzierung.
PharmaTher (OTCQB: PHRRF) أعلنت عن تقدم في برنامج تطوير من المرحلة الثالثة لتقييم الكيتامين لعَرَض الحركَة الناتج عن اللڤودوپا (LID) في مرض باركنسون عبر مسار 505(b)(2). تشمل الأصول الرئيسية أساس CMC معتمد من FDA، بيانات سريرية من المرحلة I/II تُظهر انخفاضات UDysRS (51% عند الحقنة الثانية؛ 49% عند 3 أسابيع؛ 41% عند 3 أشهر) و حماية براءة أميركية حتى مايو 2036. تستهدف الشركة سوقاً علاجياً محتملاً في الولايات المتحدة يتراوح بين 0.75 إلى 2.2 مليار دولار وتباشر اجتماع قبل المرحلة 3 مع FDA (الربع الرابع 2025–الربع الأول 2026)، وانتهاء بروتوكول حاسم (الربع الأول–الربع الثاني 2026) ومناقشات شراكة لدعم تجربة في مرحلة متقدمة في النصف الأول من 2026، رهناً بتناغم FDA والتمويل.
PharmaTher (OTCQB: PHRRF)宣布在针对帕金森病的左旋多巴引起的运动障碍（LID）治疗的三期开发计划中取得进展，采用 505(b)(2) 路径。关键资产包括经 FDA 审核的 CMC 基础、I/II 期临床数据，显示 UDysRS 的下降（输注 2 次时为 51%；3 周时为 49%；3 月时为 41%）以及 美国专利保护至 2036 年 5 月。公司瞄准在美国的潜在治疗市场为 0.75–2.2 十亿美元，并正在推进与 FDA 的 Pre-Phase 3 会晤（2025 年 Q4–2026 年 Q1）、关键性方案的最终确定（2026 年 Q1–Q2），以及为 2026 年上半年推进晚期试验的伙伴关系谈判，前提是获得 FDA 的对齐与融资。
- Phase I/II dyskinesia reductions: 51% (Infusion 2), 49% (3 weeks), 41% (3 months)
- Patent protection through May 2036 (US Patent No. 11,426,366)
- FDA-reviewed CMC platform reduces manufacturing/regulatory effort
- Implied treated-market valuation between $0.75B and $2.2B
- Pivotal study initiation contingent on FDA alignment and financing/partnering
- Treated patient estimate range is wide: 50,000–110,000 patients implied
- 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):
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
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
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
FAQ
What is PharmaTher (PHRRF) planning for ketamine in LID-Parkinson's disease in 2025–2026?
What clinical evidence does PharmaTher cite for ketamine in LID-PD (PHRRF)?
How large is the market opportunity PharmaTher (PHRRF) estimates for ketamine in LID-PD?
What regulatory route is PharmaTher (PHRRF) using to develop ketamine for LID-PD?
Does PharmaTher (PHRRF) have intellectual property for ketamine in Parkinson's?
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