Tharimmune Receives Positive Regulatory Feedback From EMA for TH104 Clinical Program for Chronic Pruritus in Primary Biliary Cholangitis
Tharimmune (NASDAQ:THAR) received positive feedback from the European Medicines Agency (EMA) regarding its TH104 clinical program for treating chronic pruritus in primary biliary cholangitis (PBC). The EMA endorsed the company's strategy, indicating no need for additional animal studies and accepting the Article 10(3) hybrid application approach. The Agency found the proposed Phase 2 study design acceptable and provided guidance for future Phase 3 studies. Tharimmune plans to initiate a Phase 2 multiple-ascending dose trial in the coming months, with topline data expected in 2025.
Tharimmune (NASDAQ:THAR) ha ricevuto un feedback positivo dalla Agenzia Europea per i Medicinali (EMA) riguardo al suo programma clinico TH104 per il trattamento del prurito cronico nella colangite biliare primaria (PBC). L'EMA ha approvato la strategia dell'azienda, indicando che non è necessario effettuare ulteriori studi sugli animali e accettando l'approccio dell'applicazione ibrida ai sensi dell'Articolo 10(3). L'Agenzia ha trovato accettabile il design dello studio di Fase 2 proposto e ha fornito indicazioni per i futuri studi di Fase 3. Tharimmune prevede di avviare un trial di Fase 2 con dosi multiple in aumento nei prossimi mesi, con dati preliminari attesi nel 2025.
Tharimmune (NASDAQ:THAR) recibió comentarios positivos de la Agencia Europea de Medicamentos (EMA) sobre su programa clínico TH104 para el tratamiento del prurito crónico en la colangitis biliar primaria (PBC). La EMA respaldó la estrategia de la empresa, indicando que no hay necesidad de estudios adicionales en animales y aceptando el enfoque de solicitud híbrida bajo el Artículo 10(3). La Agencia consideró aceptable el diseño del estudio de Fase 2 propuesto y proporcionó orientación para futuros estudios de Fase 3. Tharimmune planea iniciar un ensayo de Fase 2 de dosis múltiples en los próximos meses, con datos preliminares esperados en 2025.
Tharimmune (NASDAQ:THAR)는 유럽 의약품청 (EMA)로부터 TH104 임상 프로그램에 대한 긍정적인 피드백을 받았습니다. 이 프로그램은 원발성 담관염(PBC)에서 만성 가려움증을 치료하기 위한 것입니다. EMA는 회사의 전략을 지지하며 추가 동물실험이 필요 없음을 알리고, 제10조(3) 하이브리드 신청 접근 방식을 수용했습니다. EMA는 제안된 2상 연구 설계를 수용 가능하다고 판단하고 향후 3상 연구에 대한 지침을 제공했습니다. Tharimmune은 향후 몇 달 안에 여러 단계의 증량 시험을 시작할 예정이며, 2025년에는 주요 데이터를 기대하고 있습니다.
Tharimmune (NASDAQ:THAR) a reçu des retours positifs de l'
Tharimmune (NASDAQ:THAR) erhielt positives Feedback von der Europäischen Arzneimittel-Agentur (EMA) zu seinem TH104 klinischen Programm zur Behandlung von chronischem Pruritus bei primär biliärer Cholangitis (PBC). Die EMA unterstützte die Strategie des Unternehmens und gab an, dass keine zusätzlichen Tierversuche erforderlich sind, und akzeptierte den hybriden Antragsansatz gemäß Artikel 10(3). Die Agentur fand das vorgeschlagene Studien-Design der Phase 2 akzeptabel und gab Hinweise für zukünftige Phase-3-Studien. Tharimmune plant, in den kommenden Monaten eine Phase-2-Studie mit mehrfach ansteigenden Dosen zu starten, wobei die ersten Ergebnisse 2025 erwartet werden.
- EMA provided positive feedback on TH104 clinical program
- No additional animal studies required, reducing development costs and time
- Phase 2 study design received overall acceptance from EMA
- Article 10(3) hybrid application acceptance may streamline approval process
- None.
Insights
The EMA's positive feedback for TH104 represents a significant regulatory milestone for Tharimmune's clinical program. The Agency's acceptance of Article 10(3) hybrid application is particularly advantageous, as it allows the company to leverage existing safety data from approved products, potentially accelerating the development timeline and reducing costs.
The clearance to proceed without additional animal studies and the endorsement of the Phase 2 study design are important developments. This streamlines the path to clinical trials, with the multiple-ascending dose trial expected to begin within months and topline data anticipated in 2025. For PBC patients suffering from chronic pruritus, this progress offers hope for a new therapeutic option in an area with treatment choices.
The alignment between FDA and EMA feedback strengthens the global development strategy for TH104, potentially enabling a coordinated regulatory approach across major markets.
BRIDGEWATER, NJ / ACCESSWIRE / October 30, 2024 / Tharimmune, Inc. (NASDAQ:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company developing a portfolio of therapeutic candidates in inflammation and immunology, received positive feedback from a Scientific Advice meeting with the European Medicines Agency (EMA) that included guidance on a planned Phase 2 trial to advance TH104, the Company's lead clinical-stage candidate for moderate-to-severe pruritus in primary biliary cholangitis (PBC).
The EMA interactions specifically focused on both the Phase 2 and Phase 3 clinical program of TH104. Overall, the Agency noted that using Article 10(3), hybrid application, is acceptable and could enable referring to non-clinical and some safety data from the approved products. Regarding non-clinical information provided, the Agency endorsed the strategy presented by the Company and noted that there is no need to conduct additional animal studies and considered human exposure to be adequate to move forward. The Agency found the design and main features of the proposed Phase 2 study overall acceptable with some comments. The Agency also provided general guidance for the design of a future Phase 3 study.
"We are pleased with our interactions with both the FDA and EMA," said Randy Milby, CEO of Tharimmune. "The recent regulatory feedback from the EMA builds on the previous positive interactions with the FDA while providing a roadmap for TH104 for chronic pruritus in PBC, which continues to be a debilitating symptom for patients suffering from this rare condition. The progress with regulatory agencies is a testament to our continued commitment to advance innovative solutions in inflammation and immunology."
The Company plans to initiate a Phase 2 multiple-ascending dose trial in the coming months to assess the safety and tolerability of TH104, which will also assess the change from baseline in itch scores to evaluate chronic pruritus in PBC patients. The Company expects topline data in 2025 and continues to engage with both U.S. and EU regulatory authorities.
About TH104
TH104 is embedded with nalmefene onto a proprietary transdermal buccal film that adheres to the inside of the mouth. TH104 is a product candidate for multiple liver-related and other pruritogenic inflammatory conditions. The molecule has a dual mechanism of action affecting both the µ-opioid receptor and the kappa-opioid receptor, as well as potentially inhibiting IL-17 inflammatory cytokine expression. These opioid receptors when stimulated and/or inhibited by the body's natural ligands have been known to be involved in the body's itch circuitry.
About Pruritus and Primary Biliary Cholangitis
According to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health, PBC is a chronic disease where the bile ducts in the liver eventually become dysfunctional and cause the buildup of bile, resulting in liver damage. The disease, believed to be an autoimmune condition, affects an estimated 58 out of every 100,000 U.S. women and about 15 out of every 100,000 U.S. men. Pruritus is one of the most common conditions associated with PBC, affecting up to
About Tharimmune
Tharimmune, Inc. is a clinical-stage biotechnology company developing a diverse portfolio of therapeutic candidates in immunology and inflammation. The lead clinical asset, TH104, aims to suppress chronic pruritus associated with primary biliary cholangitis (PBC), a rare autoimmune liver disease with no known cure. The expanded pipeline includes TH023, an oral TNF-alpha inhibitor, offering a new approach to treating autoimmune diseases. Tharimmune is also advancing early-stage multi-specific biologics targeting unique epitopes against multiple solid tumors. The company has a license agreement with OmniAb, Inc. to access their antibody discovery technology for targeting specified disease markers. For more information, please visit: www.tharimmune.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, contained in this press release, including statements regarding the timing and design of Tharimmune's future Phase 2 trial, Tharimmune's strategy, future operations, future financial position, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "continue," "could," "depends," "estimate," "expect," "intend," "may," "ongoing," "plan," "potential," "predict," "project," "target," "should," "will," "would," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The Company may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements. Factors that may cause such differences, include, but are not limited to, those discussed under Risk Factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2023 and other periodic reports filed by the Company from time to time with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this release. Subsequent events and developments may cause the Company's views to change; however, the Company does not undertake and specifically disclaims any obligation to update or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by applicable law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this release.
Contacts:
Tharimmune, Inc.
ir@tharimmune.com
Alliance Advisors IR
Tirth T. Patel
tpatel@allianceadvisors.com
212-201-6614
Contact Information
Tirth Patel
LHA Investor Relations
tpatel@lhai.com
1-212-201-6614
SOURCE: Tharimmune, Inc.
View the original press release on accesswire.com
FAQ
When will Tharimmune (THAR) begin its Phase 2 trial for TH104?
When does Tharimmune (THAR) expect topline data for TH104 Phase 2 trial?
What did the EMA feedback indicate for Tharimmune's (THAR) TH104 program?
What condition is Tharimmune's (THAR) TH104 targeting?
