BRIDGEWATER, NJ - Tharimmune, Inc. (NASDAQ:THAR), a biotech company focused on inflammatory and immunological therapies, has received encouraging feedback from the European Medicines Agency (EMA) regarding its Phase 2 clinical trial plans for TH104, a drug candidate for pruritus in primary biliary cholangitis (PBC). The EMA's Scientific Advice meeting concluded that Tharimmune could use a hybrid application strategy for TH104, potentially referencing existing non-clinical and safety data from approved products.
The EMA found the proposed Phase 2 study design and main features to be generally acceptable and provided guidance for the future Phase 3 study design. No additional animal studies were deemed necessary, and human exposure levels were considered adequate for advancing the trials.
Tharimmune's CEO, Randy Milby, expressed satisfaction with the regulatory progress, noting the alignment with previous positive interactions with the U.S. Food and Drug Administration (FDA). The company plans to initiate a Phase 2 multiple-ascending dose trial soon, aiming to evaluate the safety, tolerability, and efficacy of TH104 in reducing itch scores in PBC patients. Topline data from the trial is anticipated in 2025.
TH104 is a proprietary transdermal buccal film embedding nalmefene, designed to address multiple liver-related and pruritogenic inflammatory conditions. The molecule's dual mechanism of action targets both the µ-opioid and kappa-opioid receptors and may inhibit IL-17 inflammatory cytokine expression, which is implicated in the body's itch circuitry.
PBC is a chronic autoimmune liver disease that leads to bile duct dysfunction and liver damage. Pruritus, a common symptom of PBC, affects up to 75% of patients and can significantly impact quality of life. Current treatment options are limited, and Tharimmune aims to meet this high unmet need.
Tharimmune continues to develop its portfolio, which includes TH023, an oral TNF-alpha inhibitor for autoimmune diseases, and early-stage multi-specific biologics for solid tumors. The company also has a license agreement with OmniAb, Inc. for antibody discovery technology.
This news article is based on a press release statement from Tharimmune, Inc. and does not contain any promotional content or endorsements. The information provided is intended to be factual and unbiased.
In other recent news, Tharimmune, Inc., a clinical-stage biotech firm, has been making significant strides in its clinical trials and strategic partnerships. The company has revealed promising Phase 1 data for its lead candidate, TH104, aimed at treating moderate-to-severe pruritus in patients with chronic liver disease. The trial was well received with no unexpected treatment-emergent adverse events, indicating a potential for rapid symptomatic relief. Tharimmune plans to initiate a Phase 2 trial to further assess the safety and tolerability of TH104.
In addition, Tharimmune has entered into an exclusive licensing agreement with Intract Pharma. This partnership focuses on the development of an oral form of the anti-tumor necrosis factor-alpha monoclonal antibody, infliximab, traditionally administered through intravenous infusions. The agreement grants Tharimmune worldwide development and commercialization rights to Intract Pharma's Soteria® and Phloral® technologies.
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 treatments for chronic inflammation and immune-mediated diseases.
InvestingPro Insights
As Tharimmune (NASDAQ:THAR) progresses with its clinical trials for TH104, investors should consider some key financial metrics and insights from InvestingPro. The company's market capitalization stands at a modest $2.33 million, reflecting its early-stage status in the biotech sector.
InvestingPro Tips highlight that Tharimmune holds more cash than debt on its balance sheet, which is crucial for a biotech company advancing its clinical pipeline. This financial position could provide some runway as the company moves forward with its Phase 2 trials for TH104.
However, it's important to note that Tharimmune is not currently profitable, with a negative P/E ratio of -0.26 over the last twelve months as of Q2 2024. This is not uncommon for biotech companies in the development stage, but it underscores the importance of successful clinical outcomes for the company's future.
The stock's performance has been challenging, with a significant price decline of 96.53% over the past year. This volatility is reflected in another InvestingPro Tip, which notes that the stock's price movements are quite volatile. Investors should be aware that biotech stocks often experience such fluctuations, especially as they approach critical clinical milestones.
For those interested in a deeper analysis, InvestingPro offers 12 additional tips for Tharimmune, providing a more comprehensive view of the company's financial health and market position.
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