The China Mail - 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

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 75% of individuals at some point during their disease course. It has a debilitating impact on health-related quality of life with limited treatment options.Published survey data of PBC respondents suffering from pruritus described their itch as "bugs crawling under the skin." More than 65% of patients reported that the itch was worse at night, known as nocturnal pruritus, a high unmet need.

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.
[email protected]

Alliance Advisors IR
Tirth T. Patel
[email protected]
212-201-6614

SOURCE: Tharimmune, Inc.

M.Chau--ThChM