Positive EMA Feedback Boosts Momentum for Tharimmune’s Phase 2 Trial in Treating Debilitating Itch Condition in Primary Biliary Cholangitis
Tharimmune (THAR), a clinical-stage biotechnology company specializing in innovative inflammation and immunology therapies, has received encouraging feedback from the European Medicines Agency (EMA) to advance its lead candidate, TH104. This candidate targets moderate-to-severe pruritus in patients with primary biliary cholangitis (PBC), a rare and chronic liver disease characterized by severe itching. The positive feedback received during a Scientific Advice meeting with the EMA underscores Tharimmune’s commitment to addressing the unmet needs of those affected by this debilitating condition.
The feedback from the EMA focused on Tharimmune’s planned Phase 2 and Phase 3 trials for TH104. The Agency agreed with the company’s use of a hybrid application under Article 10(3), a regulatory pathway that allows Tharimmune to reference specific non-clinical and safety data from previously approved products. This guidance could accelerate the clinical development timeline for TH104, sparing Tharimmune the time and expense of redundant animal studies while allowing the candidate to proceed directly to human trials. Importantly, the EMA found the proposed design and primary features of Tharimmune’s Phase 2 study acceptable, though it offered a few additional recommendations to enhance the trial’s design.
Tharimmune’s CEO, Randy Milby, expressed optimism over the regulatory progress, noting that the EMA’s response builds on positive interactions with the FDA. “The recent regulatory feedback from the EMA builds on our previous positive interactions with the FDA while providing a roadmap for TH104 for chronic pruritus in PBC, which continues to be a debilitating symptom for patients suffering from this rare condition. The progress with regulatory agencies is a testament to our continued commitment to advance innovative solutions in inflammation and immunology,” he stated.
Tharimmune’s commitment to alleviating pruritus, a condition that profoundly affects the quality of life for PBC patients, is reflected in its planned Phase 2 multiple-ascending dose trial for TH104. This study will evaluate the safety and tolerability of TH104 in PBC patients, focusing on the change from baseline in itch scores to assess the drug’s effectiveness in reducing chronic pruritus. The Company expects to gather topline data from this trial in 2025, a key milestone that will help inform future regulatory decisions and potentially bring relief to PBC patients suffering from severe itching.
Tharimmune’s strategy to work closely with both U.S. and EU regulatory authorities highlights the company’s dedication to ensuring its therapeutic candidates meet international standards of safety and efficacy. The path forward for TH104 in addressing chronic pruritus in PBC patients holds potential for a significant advancement in this challenging therapeutic area, where options remain limited. As Tharimmune builds on its progress with the EMA and FDA, it is positioning itself as a pioneer in developing targeted therapies for inflammatory and immunological diseases that lack effective treatments.
With the next steps outlined by the EMA, Tharimmune is well-prepared to advance TH104 through clinical trials, marking a promising development for patients and a step forward for the company in its pursuit of novel immunological solutions.
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