BRIDGEWATER, NJ - Tharimmune, Inc. (NASDAQ:THAR), a biotechnology firm focused on immunology and inflammation with a current market capitalization of $3.18 million, announced today its initiation of a Phase 2 study for TH104, a potential treatment for moderate-to-severe pruritus in primary biliary cholangitis (PBC) patients. According to InvestingPro data, the company maintains a strong liquidity position with more cash than debt on its balance sheet. The study, anticipated to commence in 2025, will build on promising Phase 1 results and regulatory feedback from the FDA and EMA.
The Phase 2 trial is a multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of TH104. It aims to enroll roughly 40 patients across the U.S., Europe, and the UK. Patients will receive escalating doses of TH104 in a nine-week study, with efficacy measured by changes in patient-reported itch scores and other quality-of-life metrics.
Chairman and CEO Randy Milby expressed optimism about advancing TH104 into the Phase 2 trial, citing the chronic and debilitating nature of pruritus associated with PBC. The company expects to present preliminary results from the Phase 2 trial by late 2025. While InvestingPro analysis indicates the company is not currently profitable, with a healthy current ratio of 2.35, Tharimmune appears well-positioned to fund its clinical development programs. InvestingPro subscribers can access 6 additional key financial insights about Tharimmune's outlook.
Tharimmune also provided a corporate update, highlighting its progress in manufacturing, clinical, and regulatory development, including positive Phase 1 results and a patent grant from the European Patent Office. The company has engaged with the medical and scientific community, sharing clinical data at industry conferences.
In addition, Tharimmune entered licensing agreements with Intract Pharma and OmniAb to expand its product pipeline and enhance early-stage immunology research. The company also appointed David Jones to its Scientific Advisory Board and Sanam Parikh to its Board of Directors, bringing in expertise in liver immunology and clinical trial management.
TH104 is a proprietary transdermal buccal film that targets opioid receptors involved in the body's itch circuitry and potentially inhibits IL-17 inflammatory cytokine expression. PBC is a rare liver disease where bile ducts become dysfunctional, leading to liver damage, and pruritus is a symptom affecting up to 75% of PBC patients.
This announcement is based on a press release statement. Tharimmune is developing a diverse portfolio of therapeutic candidates, with TH104 as its lead clinical asset aiming to suppress chronic pruritus associated with PBC. The company's stock has experienced significant volatility, declining 73.57% over the past year, though InvestingPro analysis suggests the stock may be undervalued at current levels. The company's forward-looking statements reflect management's current views and are subject to risks and uncertainties.
In other recent news, Tharimmune, Inc. has secured $2.02 million in private funding, led by Gravitas Capital and SDS Capital Group, with the proceeds earmarked for clinical development and general working capital purposes. Tharimmune also cancelled a potential merger with Intract Pharma Ltd., as disclosed in a recent SEC filing. The company appointed Sanam Parikh to its board of directors, enhancing its leadership team.
Rodman & Renshaw initiated coverage on Tharimmune, issuing a Buy rating, contingent on the successful development and commercial launch of TH104, a drug under development. The company is set to receive a European patent for its biodegradable polymeric nanoparticles technology, anticipated to enhance cancer therapies.
Tharimmune has received positive feedback from the European Medicines Agency (EMA) regarding its Phase 2 clinical trial plans for TH104, aimed at treating pruritus in primary biliary cholangitis (PBC). Phase 1 data for TH104 shows promise, with no unexpected treatment-emergent adverse events reported. Tharimmune has also entered into an exclusive licensing agreement with Intract Pharma for an innovative oral delivery platform for anti-inflammatory treatments.
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