Tharimmune Announces Phase 2 Study Plan for TH104 in Patients With Moderate-to-Severe Pruritus Associated With Primary Biliary Cholangitis and Provides a Business Update
Tharimmune (NASDAQ:THAR) has announced plans for a Phase 2 study of TH104 in patients with moderate-to-severe pruritus associated with primary biliary cholangitis (PBC), set to launch in 2025. The multicenter, randomized trial will evaluate approximately 40 patients across the U.S., Europe, and UK.
Key 2024 achievements include: positive Phase 1 results showing favorable pharmacokinetics and safety profile, regulatory feedback from FDA and EMA, successful manufacturing progress, and licensing agreements with Intract Pharma and OmniAb. The company raised over $4 million through private placements to support clinical development.
The company also expanded its Board of Directors with the appointment of Sanam Parikh, bringing expertise in clinical trial management and regulatory submissions.
Tharimmune (NASDAQ:THAR) ha annunciato piani per uno studio di Fase 2 di TH104 in pazienti con prurito da moderato a grave associato a colangite biliare primaria (PBC), che sarà avviato nel 2025. Il trial multicentrico, randomizzato, valuterà circa 40 pazienti negli Stati Uniti, in Europa e nel Regno Unito.
I risultati chiave del 2024 includono: risultati positivi della Fase 1 che mostrano farmacocinetica favorevole e un profilo di sicurezza, feedback normativo da FDA ed EMA, progressi produttivi di successo e accordi di licenza con Intract Pharma e OmniAb. L'azienda ha raccolto oltre 4 milioni di dollari tramite collocamenti privati per sostenere lo sviluppo clinico.
L'azienda ha anche ampliato il proprio Consiglio di Amministrazione con la nomina di Sanam Parikh, che porta esperienza nella gestione di studi clinici e nelle presentazioni regolatorie.
Tharimmune (NASDAQ:THAR) ha anunciado planes para un estudio de Fase 2 de TH104 en pacientes con prurito de moderado a severo asociado con colangitis biliar primaria (PBC), que se lanzará en 2025. El estudio multicéntrico y aleatorizado evaluará aproximadamente a 40 pacientes en EE. UU., Europa y el Reino Unido.
Los logros clave de 2024 incluyen: resultados positivos de Fase 1 que muestran farmacocinética favorable y un perfil de seguridad, comentarios regulatorios de la FDA y la EMA, avances en la fabricación exitosos y acuerdos de licencia con Intract Pharma y OmniAb. La compañía recaudó más de 4 millones de dólares a través de colocaciones privadas para apoyar el desarrollo clínico.
La compañía también amplió su Junta Directiva con el nombramiento de Sanam Parikh, aportando experiencia en gestión de ensayos clínicos y presentaciones regulatorias.
Tharimmune (NASDAQ:THAR)는 2025년에 시작될 예정인 원발 담즙성 담관염(PBC)와 관련된 중등도에서 중증 가려움을 겪고 있는 환자를 대상으로 TH104의 2상 연구 계획을 발표했습니다. 이 다기관 무작위 시험은 미국, 유럽, 영국에서 약 40명의 환자를 평가할 예정입니다.
2024년 주요 성과는: 유리한 약리학적 약물 동태와 안전성 프로필을 보여주는 긍정적인 1상 결과, FDA 및 EMA의 규제 피드백, 성공적인 제조 진행 및 Intract Pharma와 OmniAb와의 라이센스 계약 등이 포함됩니다. 이 회사는 임상 개발을 지원하기 위해 사모 배치를 통해 400만 달러 이상을 모금했습니다.
회사는 임상 시험 관리 및 규제 제출에 대한 전문성을 가진 Sanam Parikh를 이사회에 임명하여 이사회를 확대했습니다.
Tharimmune (NASDAQ:THAR) a annoncé des projets pour une étude de Phase 2 de TH104 chez des patients souffrant de prurit modéré à sévère associé à une cholangite biliaire primitive (PBC), qui devrait commencer en 2025. L'essai multicentrique et randomisé évaluera environ 40 patients aux États-Unis, en Europe et au Royaume-Uni.
Les réalisations clés de 2024 incluent : des résultats positifs de la Phase 1 montrant une pharmacocinétique favorable et un profil de sécurité, des retours réglementaires de la FDA et de l'EMA, des progrès de fabrication réussis et des accords de licence avec Intract Pharma et OmniAb. L'entreprise a levé plus de 4 millions de dollars grâce à des placements privés pour soutenir le développement clinique.
L'entreprise a également élargi son conseil d'administration avec la nomination de Sanam Parikh, apportant son expertise en gestion d'essais cliniques et en soumissions réglementaires.
Tharimmune (NASDAQ:THAR) hat Pläne für eine Phase-2-Studie von TH104 bei Patienten mit mäßigem bis schwerem Juckreiz, der mit primärer biliärer Cholangitis (PBC) verbunden ist, angekündigt, die 2025 starten soll. Die multizentrische, randomisierte Studie wird voraussichtlich etwa 40 Patienten in den USA, Europa und Großbritannien bewerten.
Wichtige Erfolge im Jahr 2024 umfassen: positive Ergebnisse der Phase 1, die eine günstige Pharmakokinetik und ein Sicherheitsprofil zeigen, regulatorisches Feedback von der FDA und EMA, erfolgreiche Fortschritte in der Herstellung und Lizenzvereinbarungen mit Intract Pharma und OmniAb. Das Unternehmen hat über 4 Millionen Dollar durch Privatplatzierungen gesammelt, um die klinische Entwicklung zu unterstützen.
Das Unternehmen hat auch seinen Vorstand mit der Ernennung von Sanam Parikh erweitert, die Expertise im Bereich des Managements von klinischen Studien und regulatorischen Einreichungen mitbringt.
- Successful completion of Phase 1 trial with favorable results
- Secured over $4 million in private placement financing
- Obtained positive FDA and EMA feedback for Phase 2 trial design
- Established strategic licensing agreements with Intract Pharma and OmniAb
- Granted European patent for novel therapeutic delivery system
- Additional capital may be needed to complete Phase 2 trial and future development
- Phase 2 trial initiation delayed to 2025
Insights
The planned Phase 2 study for TH104 represents a significant milestone in addressing pruritus in PBC patients. The 40-patient multicenter trial employs a robust design with double-blind, placebo-controlled methodology. The focus on the WI-NRS scoring system provides a validated endpoint for measuring clinical efficacy. The preliminary results expected in late 2025 could be pivotal for this $3.2M market cap company.
The positive Phase 1 results showing favorable pharmacokinetics and safety profile, combined with constructive feedback from both FDA and EMA, strengthen the development pathway. The manufacturing validation progress and secured patent protection in Europe provide additional technical and intellectual property support for the program. The
The company's strategic positioning shows promise with multiple value-creating catalysts ahead. The
The addition of clinical operations expertise to the board strengthens oversight capabilities important for the upcoming Phase 2 trial execution. The positive regulatory feedback from both FDA and EMA reduces development risk and provides clearer path to market. However, investors should note the early stage nature and significant capital requirements typically needed to advance rare disease programs through clinical development.
BRIDGEWATER, NJ / ACCESSWIRE / December 16, 2024 / Tharimmune, Inc. (Nasdaq:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company committed to pioneering therapies in immunology and inflammation, today announced plans for initiating a Phase 2 study evaluating TH104 in patients suffering from moderate-to-severe pruritus (severe itching) associated with primary biliary cholangitis (PBC), a rare and chronic liver disease, and also provided a corporate update. The launch of this clinical trial, expected in 2025, follows favorable results from Tharimmune's Phase 1 study with TH104, recent regulatory feedback from the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), as well as progress on manufacturing clinical study supply.
Business Update and 2024 Corporate Highlights
Throughout 2024 Tharimmune achieved significant milestones across three key areas. These accomplishments reflect progress in advancing innovative therapies in inflammation and immunology, with a focus on improving patient outcomes in areas of high unmet need.
Manufacturing, Clinical and Regulatory Progress
Validation and batches of manufacturing supply of TH104 for Phase 2 clinical study are on track for year-end.
Announced positive results from a Phase 1 clinical trial of TH104 in healthy subjects, demonstrating a favorable pharmacokinetic profile and a mild side-effect profile.
Received positive regulatory feedback from the FDA and EMA for the TH104 clinical program, providing guidance on the Phase 2 trial design.
Granted a patent from the European Patent Office covering therapeutics created for carrying antibody and peptide therapies, representing a novel solution and addressing critical challenges with stability and absorption.
Medical and Scientific Community Engagement
Participated in key industry conferences to present new clinical data and engage with the scientific community.
Presented favorable clinical data at the American College of Gastroenterology (ACG) Annual Scientific Meeting, reinforcing the safety profile of TH104 with no unexpected treatment-emergent adverse events.
Shared positive clinical data at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting®, highlighting a significant correlation between blood levels and symptom relief in patients treated with TH104.
Corporate Achievements
Entered into a licensing agreement with Intract Pharma, aiming to expand Tharimmune's product pipeline to develop oral biologics including an oral formulation of infliximab.
Entered into a licensing agreement with OmniAb, accessing their antibody discovery technology platform to enhance Tharimmune's early-stage immunology pipeline.
Appointed David Jones, Professor of Liver Immunology at Newcastle University in England and renowned scientist with extensive expertise in hepatic pathologies and PBC, to Tharimmune's Scientific Advisory Board.
Completed private placement financings, raising more than
$4 million to support clinical development and working capital, including TH104 development program.
TH104 Phase 2 Clinical Study
The multicenter, randomized, double-blind, placebo-controlled Phase 2 trial is designed to assess the safety, tolerability and efficacy of TH104 in reducing itch in PBC patients with moderate-to-severe pruritus, a condition that significantly impacts daily lives and remains an area of unmet medical need. The study plans to enroll approximately 40 patients at sites in the U.S., Europe and the UK. Patients will receive escalating doses of TH104 in a nine-week study that includes treatment and observation periods, with efficacy measured by changes in patient-reported itch scores utilizing the Worst-Itch Numerical Rating Scale (WI-NRS), a relevant clinical outcome assessment for pruritus, as well as other quality-of-life metrics. Additional information on the Phase 2 study is available on ClinicalTrials.gov (NCT06733519).
"Following feedback from global regulators including guidance on a future Phase 3 program, we are delighted to advance TH104 into this Phase 2 clinical trial planned for 2025, marking a critical milestone in our efforts to address the debilitating effects of chronic pruritus. Our focus on innovative delivery mechanisms that target the opioid receptors involved in the body's itch circuitry underscores the favorable data collected thus far in clinical development. We plan to report preliminary results from this Phase 2 trial in late 2025," said Randy Milby, Chairman and CEO of Tharimmune.
Board of Directors Expansion
Additionally, Tharimmune announced the appointment of Sanam Parikh to its Board of Directors, expanding the size of its Board to six Directors. Mr. Parikh brings to Tharimmune significant experience in clinical trial management, regulatory submissions and operational oversight.
Mr. Parikh has managed clinical studies across various global sites, overseeing CRO partnerships and site management to ensure compliance with complex regulatory standards. His experience includes site feasibility, budget negotiation, contract management and regulatory interactions, with particular expertise working under FDA and EMA guidelines. Earlier in his career, Mr. Parikh was an associate clinical project manager in oncology at Clario, and held various research laboratory positions prior to that.
"Sanam is an emerging leader in preclinical and clinical study management. His background in oncology-focused clinical operations along with a proven record in managing critical aspects of trial execution will significantly bolster our capabilities," added Mr. Milby. "Furthermore, his in-depth knowledge of clinical operations and his focus on ensuring study integrity from preclinical work through to regulatory submissions aligns with our strategic goals as we continue to develop and validate our oncology-focused product pipeline."
Mr. Parikh holds a Master's in Public Health with a focus on Urban Public Health from Rutgers University, and a Bachelor's in Biology from the New Jersey Institute of Technology.
About TH104
TH104 is embedded with nalmefene onto a proprietary transdermal buccal film that easily adheres to the inside of the mouth. This endows TH104 with key features making it an ideal 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 rare and chronic disease where the bile ducts in the liver eventually become dysfunctional and cause the buildup of bile, resulting in liver damage. Pruritus is a common condition 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, inflammation and oncology. Its 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
SOURCE: Tharimmune, Inc.
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