BRIDGEWATER, NJ - Tharimmune, Inc. (NASDAQ:THAR), a clinical-stage biotechnology company, has announced new Phase 1 data for its lead candidate TH104, aimed at treating moderate-to-severe pruritus in patients with chronic liver disease (CLD). The data, presented at the American College of Gastroenterology 2024 Annual Scientific Meeting in Philadelphia, indicates that TH104 was well tolerated with no unexpected treatment-emergent adverse events, bolstering the case for its continued clinical development.
The Phase 1 trial was a single-dose, single-center, open-label, randomized study conducted in two cohorts of CLD patients categorized by the Child-Pugh score, which assesses the severity of liver disease. The study aimed to determine the safety and tolerability of a single buccal dose of TH104. Results showed a mean reduction in itch scores of 33.3% just 24 hours after a single dose, suggesting potential for rapid symptomatic relief.
No serious adverse events or deaths were reported during the study. The data also revealed no opioid withdrawal effects measured by the Clinical Opiate Withdrawal Scale (COWS), reinforcing the safety profile of TH104. The company plans to initiate a Phase 2 multiple-ascending dose trial to further assess the safety and tolerability of TH104, with topline data expected in 2025.
TH104 utilizes a proprietary microparticle embedded transmucosal delivery system, which allows for rapid and predictable delivery of the active ingredient, nalmefene. The molecule targets both the µ-opioid receptor and the kappa-opioid receptor, potentially inhibiting IL-17 inflammatory cytokine expression, which are known to be involved in the body's itch circuitry.
Pruritus, or chronic itching, is a common symptom of primary biliary cholangitis (PBC), a chronic autoimmune liver disease. According to the National Institute of Diabetes and Digestive and Kidney Diseases, PBC affects an estimated 58 out of every 100,000 U.S. women and about 15 out of every 100,000 U.S. men. Pruritus can significantly impact the quality of life, and there is a high unmet need for effective treatments.
Tharimmune is developing a diverse portfolio of therapeutic candidates in immunology and inflammation. The company's pipeline also includes TH023, an oral TNF-alpha inhibitor for autoimmune diseases, and early-stage multi-specific biologics for solid tumors. Tharimmune has partnered with OmniAb, Inc. to access antibody discovery technology for targeting specific disease markers.
This report is based on a press release statement from Tharimmune, Inc.
In other recent news, Tharimmune, Inc., a clinical-stage biotech firm, has entered into an exclusive licensing agreement with Intract Pharma. The partnership focuses on the development of an oral form of the anti-tumor necrosis factor-alpha (TNF-α) monoclonal antibody, infliximab, which is typically administered through intravenous infusions. This agreement gives Tharimmune worldwide development and commercialization rights, excluding South Korea, to Intract Pharma's Soteria® and Phloral® technologies, along with an existing supply contract for infliximab.
Intract Pharma will receive an upfront payment and may earn additional payments upon equity financing by Tharimmune. They are also eligible for future development, regulatory, and commercial milestones, along with mid-single-digit royalties on net product sales. The partnership is expected to enhance targeted delivery of therapeutics to the colon or small intestine, improving the effectiveness of TNF-α inhibitors.
These recent developments underscore Tharimmune's ongoing efforts to expand its immunology focus and offer more accessible treatment options. The collaboration with Intract Pharma is anticipated to accelerate the oral anti-TNFα antibody into clinical trials, addressing the medical need for safer and orally available biological treatments for chronic inflammation and immune-mediated diseases.
InvestingPro Insights
While Tharimmune's recent clinical data for TH104 shows promise, the company's financial metrics reveal significant challenges. According to InvestingPro data, Tharimmune's market capitalization stands at a modest $2.24 million, reflecting the early-stage nature of its pipeline. The company's price-to-book ratio of 0.33 suggests that the market is valuing the company below its book value, which could indicate investor skepticism about its future prospects or undervaluation.
InvestingPro Tips highlight that Tharimmune is not currently profitable, with an adjusted operating income of -$9.1 million for the last twelve months as of Q2 2024. This aligns with the company's focus on clinical-stage development, where significant investments are required before potential commercialization. The stock's performance has been notably weak, with InvestingPro reporting a one-year price total return of -97.03% as of the latest data.
Despite these financial challenges, Tharimmune maintains a strong liquidity position. An InvestingPro Tip notes that the company "holds more cash than debt on its balance sheet," which is crucial for funding ongoing clinical trials and operations. This financial cushion may provide some reassurance to investors as Tharimmune progresses its pipeline candidates, including the promising TH104.
For investors considering Tharimmune's potential, it's worth noting that InvestingPro offers 14 additional tips that could provide further insights into the company's financial health and market position. These additional tips could be particularly valuable given the volatile nature of biotech stocks, especially those in early clinical stages.
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