PharmaTher Advances Phase 3 FDA Package for Ketamine in LID-Parkinson's Disease
PharmaTher (OTCQB: PHRRF) is preparing a Pre-Phase 3 (Type B) FDA briefing package to align on a single, well-controlled Phase 3 study for ketamine in levodopa-induced dyskinesia in Parkinson's disease under a 505(b)(2) pathway.
Key clinical inputs: prior Phase I/II showed UDysRS reductions of 51% during Infusion 2, 49% at 3 weeks and 41% at 3 months; ketamine was described as generally safe and well tolerated. Company cites an estimated U.S. treated market of $0.75–$2.2 billion. PharmaTher holds U.S. patent coverage through 2036 (U.S. Patent No. 11,426,366).
Near-term milestones: submit Pre-Phase 3 package in Q4 2025–Q1 2026, finalize Phase 3 protocol in Q1–Q2 2026, and initiate Phase 3 from 1H 2026 onward contingent on FDA alignment and partnering/financing.
PharmaTher (OTCQB: PHRRF) sta preparando un pacchetto di briefing FDA Pre-Phase 3 (Tipo B) per allinearsi su uno studio di Fase 3 ben controllato per la ketamina nella discinesia indotta da levodopa nella malattia di Parkinson, nell’ambito di una via 505(b)(2).
Input clinici principali: i precedenti studi di fase I/II hanno mostrato riduzioni UDysRS del 51% durante l’Infusione 2, 49% a 3 settimane e 41% a 3 mesi; la ketamina è stata descritta come generalmente sicura e ben tollerata. L’azienda cita un mercato statunitense trattato stimato di $0,75–$2,2 miliardi. PharmaTher detiene copertura di brevetti statunitensi fino al 2036 (Brevetto USA n. 11,426,366).
Milestones a breve termine: presentare il pacchetto Pre-Phase 3 nel Q4 2025–Q1 2026, finalizzare il protocollo di Fase 3 nel Q1–Q2 2026, e avviare la Fase 3 a partire dal 1H 2026 in avanti, subordinatamente all’allineamento con la FDA e al partenariato/finanziamento.
PharmaTher (OTCQB: PHRRF) está preparando un paquete de briefing de la FDA Pre-Fase 3 (Tipo B) para alinear un único estudio de Fase 3 bien controlado de ketamina en la discinesia inducida por levodopa en la enfermedad de Parkinson bajo una vía 505(b)(2).
Entradas clínicas clave: estudios previos de Fase I/II mostraron reducciones de UDysRS del 51% durante la Infusión 2, 49% a las 3 semanas y 41% a los 3 meses; la ketamina se describió como generalmente segura y bien tolerada.La compañía estima un mercado tratado en EE. UU. de $0,75–$2,2 mil millones. PharmaTher tiene cobertura de patentes en EE. UU. hasta el 2036 (Patente de EE. UU. No. 11,426,366).
Hitos a corto plazo: presentar el paquete Pre-Fase 3 en Q4 2025–Q1 2026, finalizar el protocolo de Fase 3 en Q1–Q2 2026, e iniciar la Fase 3 a partir de 1H 2026 en adelante, sujeto al alineamiento de la FDA y a la asociación/financiación.
PharmaTher (OTCQB: PHRRF)은 레보도파 유발 운동 이상증(Parkinson 질환의)에서 케타민의 단일하고 잘 제어된 3상 연구를 맞추기 위해 병행하는 Pre-Phase 3 FDA 브리핑 패키지를 준비 중이며, 505(b)(2) 경로를 따릅니다.
주요 임상 입력: 이전의 1상/2상에서 UDysRS 감소가 Infusion 2에서 51%, 3주 시점에서 49%, 3개월에서 41%로 나타났고, 케타민은 일반적으로 안전하고 내약성이 우수한 것으로 기술되었습니다. 회사는 미국 내 치료 가능 시장을 $0.75–$2.2십억으로 추정합니다. PharmaTher는 미국 특허 커버리지를 2036년까지 보유하고 있으며(미 특허 No. 11,426,366).
단기 이정표: 2025년 4분기–2026년 1분기에 Pre-Phase 3 패키지를 제출하고, 2026년 1–2분기에 3상 프로토콜을 확정하며, 2026년 상반기 이후 FDA 정렬 및 파트너십/자금 조달에 따라 1단계 3상을 시작합니다.
PharmaTher (OTCQB: PHRRF) prépare un package de briefing FDA Pre-Phase 3 (Type B) afin de s’aligner sur une étude Phase 3 unique et bien contrôlée sur la kétamine dans la disqueacinie induite par la lévodopa dans la maladie de Parkinson, dans le cadre d’une voie 505(b)(2).
Entrées cliniques clés : les données des phases I/II précédentes ont montré des réductions UDysRS de 51% lors de l’infusion 2, 49% à 3 semaines et 41% à 3 mois ; la kétamine a été décrite comme généralement sûre et bien tolérée. La société estime un marché américain traité de $0,75–$2,2 milliards. PharmaTher détient une couverture de brevets américains jusqu’en 2036 (Brevet américain n° 11,426,366).
Jalons à court terme : soumettre le paquet Pre-Phase 3 au Q4 2025–Q1 2026, finaliser le protocole de Phase 3 au Q1–Q2 2026, et lancer la Phase 3 à partir du 1H 2026 sous réserve de l’alignement avec la FDA et du partenariat/financement.
PharmaTher (OTCQB: PHRRF) bereitet ein FDA-Briefing-Paket Pre-Phase-3 (Typ B) vor, um sich auf eine einheitliche, gut kontrollierte Phase-3-Studie zur Ketamin in der levodopaindizierten Dyskinesie bei Parkinson vorzubereiten, im Rahmen eines 505(b)(2)-Weges.
Wichtige klinische Eingaben: Frühere Phase-I/II zeigten UDysRS-Reduktionen von 51% während Infusion 2, 49% nach 3 Wochen und 41% nach 3 Monaten; Ketamin wurde allgemein als sicher und gut verträglich beschrieben. Das Unternehmen schätzt einen behandelbaren US-amerikanischen Markt von $0,75–$2,2 Milliarden. PharmaTher hält US-Patentschutz bis 2036 (US-Patent Nr. 11,426,366).
Kurzfristige Meilensteine: Einreichung des Pre-Phase-3-Pakets in Q4 2025–Q1 2026, Finalisierung des Phase-3-Protokolls in Q1–Q2 2026 und Initiierung von Phase 3 ab 1H 2026 vorbehaltlich FDA-Ausrichtung und Partnerschaft/Finanzierung.
PharmaTher (OTCQB: PHRRF) يستعد حزمة إحاطة FDA قبل المرحلة 3 (النوع B) للتماشي مع دراسة المرحلة 3 الواحدة والمضبوطة جيداً من Ketamine في خلل الحركة الناتج عن ليفودوبا في مرض باركنسون بموجب مسار 505(b)(2).
مدخلات سريرية رئيسية: أظهرت نتائج مراحل I/II السابقة خفض UDysRS بنسبة 51% أثناء الحقنة 2، و49% عند 3 أسابيع و41% عند 3 أشهر؛ ووصفت Ketamine بأنها آمنة بشكل عام ومتحملة جيداً. وتُشير الشركة إلى سوق أمريكي مُعالج مُقدر بـ $0.75–$2.2 مليار. تمتلك PharmaTher حماية براءات الاختراع الأمريكية حتى 2036 (براءة الولايات المتحدة No. 11,426,366).
المعالم القريبة: تقديم حزمة Pre-Phase 3 في الربع الرابع 2025–الربع الأول 2026، وإكمال بروتوكول المرحلة 3 في الربع الأول–الثاني 2026، وبدء المرحلة 3 من النصف الأول 2026 فصاعداً رهناً بتوافق FDA والشراكة/التمويل.
PharmaTher (OTCQB: PHRRF) 正在准备一个 Pre-Phase 3（B 型）FDA 简报包，以就一项单一、受控良好的 第三阶段 研究达成一致，该研究针对帕金森病的多巴胺能药物半乳糖酶诱发的运动障碍中的氯胺酚（ketamine），遵循 505(b)(2) 路径。
关键临床输入：先前的 I/II 期显示 UDysRS 在 Infusion 2 期间下降 51%，在 3 周时下降 49%，在 3 个月时下降 41%；氯胺酚通常被描述为安全且耐受性良好。公司引用美国治疗市场估算为 $0.75–$2.2B。PharmaTher 对美国专利覆盖至 2036 年（美国专利 No. 11,426,366）。
近期里程碑：在 2025 年第 4 季至 2026 年第 1 季 提交 Pre-Phase 3 包，2026 年第 1–2 季 确定第三阶段方案，并在 2026 年上半年及以后 在获得 FDA 对齐及合作/融资的前提下启动 Phase 3。
- UDysRS reductions of 51% during Infusion 2
- UDysRS reductions of 49% at 3 weeks
- U.S. patent protection through 2036
- Estimated U.S. treated market of $0.75–$2.2B
- Phase 3 start is contingent on FDA alignment and securing partnering/financing
- Planned registrational path depends on single-trial acceptance under 505(b)(2)
Company preparing FDA meeting package to align on a single, well-controlled Phase 3 study under 505(b)(2); Pharma partner discussions ongoing
Toronto, Ontario--(Newsfile Corp. - October 16, 2025) - PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) (the "Company" or "PharmaTher"), a specialty life sciences company focused on unlocking the pharmaceutical potential of ketamine, today announced that it 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") and that prospective pharma partners are currently evaluating potential collaboration structures for the registrational program and commercialization.
Key Updates
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, 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 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 (
Market Opportunity
As previously communicated, PharmaTher estimates a U.S. treated market opportunity of approximately US
Planned Near-Term Milestones
- Q4 2025 — Q1 2026: Submit Pre-Phase 3 meeting request and briefing package; hold FDA meeting and receive minutes.
- Q1 — Q2 2026: Finalize Phase 3 protocol (primary and key secondary endpoints, inclusion/exclusion, statistical plan) per FDA feedback.
- 1H 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 center on dyskinesia severity and impact—such as the Unified Dyskinesia Rating Scale (UDysRS)—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
PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a specialty life sciences company focused on unlocking the pharmaceutical potential of ketamine. 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 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, clinical development, CMC package, regulatory approvals, market acceptance and opportunities, competition, market size, the Company programs being partnered. 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", "purpose", "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.
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FAQ
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