Tharimmune Presents Positive Clinical Data at AASLD the Liver Meeting(R) to Support TH104 for Chronic Pruritus in Chronic Liver Disease
Tharimmune (NASDAQ:THAR) presented Phase 1 clinical data for TH104 at AASLD The Liver Meeting 2024. The trial evaluated TH104 transmucosal buccal film in patients with chronic liver disease (CLD) for chronic pruritus treatment. The study showed significant correlation between blood levels and symptom relief, with a correlation coefficient of 0.7060 (p=0.0103). Patients experienced a mean reduction in itch scores of 33.3% 24 hours after a single dose. The treatment was well-tolerated with only two mild adverse events reported. The company plans to initiate a Phase 2 multiple-ascending dose trial with topline data expected in 2025.
Tharimmune (NASDAQ:THAR) ha presentato dati clinici di Fase 1 per TH104 durante l'AASLD The Liver Meeting 2024. Lo studio ha valutato il film buccale transmucoso TH104 in pazienti affetti da malattia epatica cronica (CLD) per il trattamento del prurito cronico. La ricerca ha mostrato una correlazione significativa tra i livelli ematici e il sollievo dai sintomi, con un coefficiente di correlazione di 0.7060 (p=0.0103). I pazienti hanno sperimentato una riduzione media del punteggio del prurito del 33,3% 24 ore dopo una singola dose. Il trattamento è stato ben tollerato, con solo due eventi avversi lievi riportati. L'azienda prevede di avviare un trial di Fase 2 con dosi multiple in aumento, con dati preliminari attesi nel 2025.
Tharimmune (NASDAQ:THAR) presentó datos clínicos de Fase 1 para TH104 en AASLD The Liver Meeting 2024. El ensayo evaluó la película bucal transmucosa TH104 en pacientes con enfermedad hepática crónica (CLD) para el tratamiento del prurito crónico. El estudio mostró una correlación significativa entre los niveles en sangre y el alivio de los síntomas, con un coeficiente de correlación de 0.7060 (p=0.0103). Los pacientes experimentaron una reducción media en las puntuaciones de picazón del 33.3% 24 horas después de una sola dosis. El tratamiento fue bien tolerado, con solo dos eventos adversos leves reportados. La compañía planea iniciar un ensayo de Fase 2 con dosis múltiples en aumento, con datos preliminares esperados en 2025.
Tharimmune (NASDAQ:THAR)는 AASLD The Liver Meeting 2024에서 TH104에 대한 1상 임상 데이터를 발표했습니다. 이 시험은 만성 간 질환(CLD) 환자에서 만성 가려움증 치료를 위해 TH104의 점막 투과 구강 필름을 평가했습니다. 연구 결과, 혈중 농도와 증상 완화 간의 유의미한 상관관계가 나타났으며, 상관 계수는 0.7060(p=0.0103)였습니다. 환자들은 단일 용량 투여 24시간 후 가려움증 점수가 평균 33.3% 감소했습니다. 치료는 잘 견뎌졌으며, 경증의 부작용이 두 건만 보고되었습니다. 회사는 2상 다수 상승 용량 연구를 시작할 계획이며, 주요 데이터는 2025년에 기대됩니다.
Tharimmune (NASDAQ:THAR) a présenté des données cliniques de Phase 1 pour TH104 lors de la réunion AASLD The Liver Meeting 2024. L'essai a évalué le film buccal transmucosal TH104 chez des patients atteints de maladie hépatique chronique (CLD) pour le traitement du prurit chronique. L'étude a montré une corrélation significative entre les niveaux sanguins et le soulagement des symptômes, avec un coefficient de corrélation de 0.7060 (p=0.0103). Les patients ont connu une réduction moyenne de 33,3 % de leur score de démangeaison 24 heures après une seule dose. Le traitement a été bien toléré avec seulement deux événements indésirables légers rapportés. La société prévoit de lancer un essai de Phase 2 avec augmentation multiple des doses, avec des données préliminaires attendues en 2025.
Tharimmune (NASDAQ:THAR) präsentierte klinische Daten der Phase 1 für TH104 auf der AASLD The Liver Meeting 2024. Die Studie bewertete den transmukosalen oralen Film TH104 bei Patienten mit chronischer Lebererkrankung (CLD) zur Behandlung von chronischem Juckreiz. Die Studie zeigte eine signifikante Korrelation zwischen Blutspiegeln und Symptomlinderung, mit einem Korrelationskoeffizienten von 0.7060 (p=0.0103). Die Patienten berichteten 24 Stunden nach einer Einzeldosis von einer durchschnittlichen Reduktion der Juckreizwerte um 33,3%. Die Behandlung wurde gut vertragen, es wurden nur zwei milde Nebenwirkungen gemeldet. Das Unternehmen plant den Start einer Phase-2-Studie mit mehrfach steigenden Dosen, wobei die Ergebnisse voraussichtlich 2025 vorliegen werden.
- Strong correlation (r=0.7060) between drug levels and symptom improvement
- 33.3% mean reduction in itch scores after 24 hours from single dose
- Favorable safety profile with only two mild adverse events
- Phase 2 trial advancement planned with data expected in 2025
- Single-dose study with patient population (12 subjects)
- Only evaluated short-term effects (24-hour period)
Insights
The Phase 1 clinical data for TH104 shows promising results in treating chronic pruritus in liver disease patients. The key findings demonstrate a significant correlation (
The safety profile is particularly encouraging, with only two mild headaches reported and no serious adverse events. This tolerability is important for chronic conditions requiring long-term treatment. The study's inclusion of both Child-Pugh A and B patients suggests potential applicability across different liver disease severities.
The upcoming Phase 2 trial will be critical in validating these early results. The use of the validated WI-NRS scoring system adds credibility to the efficacy measurements, though investors should note that larger patient populations and longer treatment durations will be needed to confirm these findings.
Significant correlation shown between blood levels and symptom relief; TH104 was well tolerated with no unexpected treatment-emergent adverse events
Phase 2 preliminary data for chronic pruritus in primary biliary cholangitis expected in 2025
BRIDGEWATER, NJ / ACCESSWIRE / November 18, 2024 / Tharimmune, Inc. (Nasdaq:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company developing a portfolio of therapeutic candidates in inflammation and immunology, presented new TH104 clinical data at the American Association for the Study of Liver Disease (AASLD) The Liver Meeting® 2024, underway in San Diego from November 15-19. The Phase 1 trial was a single-dose, single-center, open-label, randomized study of TH104 transmucosal buccal film conducted in two cohorts of patients with chronic liver disease (CLD), with the primary outcome of safety and tolerability.
"This presentation at The Liver Meeting expands the audience for encouraging Phase 1 data with our lead candidate TH104," said Randy Milby, CEO of Tharimmune. "We look forward to initiating a Phase 2 multiple-ascending dose trial in the coming months to evaluate TH104 in chronic pruritus in primary biliary cholangitis (PBC) patients, with topline data expected in 2025. In the meantime, we continue to engage with both U.S. and EU regulatory authorities."
Data presented at The Liver Meeting include adverse events (AEs) as well as an assessment of patients' relief of pruritus symptom scores when correlated to pharmacokinetics (PK) of TH104. Patients with cholestatic liver disease and a known history of persistent generalized pruritus for at least 4 weeks prior to screening were included. After an overnight fast of 10 hours, subjects received a single low dose of TH104. Serial blood samples for PK analysis were taken, and patients were monitored for itch severity scores utilizing the Worst-Itch Numerical Rating Scale (WI-NRS), a relevant clinical outcome assessment for pruritus in chronic liver disease, and for itch intensity over a 24-hour period.
Pruritus is common in most liver diseases and the WI-NRS is a validated numerical rating scale displaying 11 numbers ranging from 0, representing "no itch," to 10, representing "worst imaginable itch," and patients are asked to pick the number corresponding to the intensity of their pruritus. Results from multiple large studies support the usefulness and validity of WI-NRS for evaluating change over time in clinical trials. Pearson's correlation coefficient (r) was used to assess the correlation between TH104 concentration (ng/ml) Area Under the Curve (AUC) and the change in WI-NRS score 48 hours after dosing.
This study screened 19 patients and 12 were enrolled with two types of CLD categorized as Child-Pugh A (cohort A) and Child-Pugh B (cohort B). The Child-Pugh score is a system for assessing the prognosis and necessity of transplant in CLD that provides a forecast of the increasing severity of a patient's liver disease and expected survival rate. The score is determined by scoring clinical measures of liver disease and the possibility of eventual liver failure, with Class A indicating mild liver disease and Class B indicating moderate liver disease with one-to-five-year survival rates of
The correlation coefficient between TH104 AUC and change in itch, r, was 0.7060, with a p-value of 0.0103 and a
The mean baseline WI-NRS scores in Groups A and B were 4.33 and 6.17, respectively, translating to moderate-to-severe chronic pruritus at the start of the study. The mean baseline itch score for all 12 subjects was 5.25. At one-hour post-dosing with TH104, Group A and Group B had a mean decline in WI-NRS scores of
A total of two AEs (headache) were reported in two subjects over the course of the study. These AEs were mild and possibly related to study drug, with no serious adverse events reported. There were no deaths or other significant adverse events reported during the entire study. There were no new adverse events during the study, with events correlated with previous studies and a safety profile consistent with the literature for the active ingredient in TH104.
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 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, 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
Contact Information
Tirth Patel
Alliance Advisors IR
tpatel@allianceadvisors.com
1-212-201-6614
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SOURCE: Tharimmune, Inc.
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