Tharimmune Reports Positive EMA Regulatory Feedback for TH104 Clinical Program
DENVER, Colo., Oct 30, 2024 (247marketnews.com)- Tharimmune (NASDAQ: THAR) reported receiving positive feedback at its Scientific Advice meeting with the European Medicines Agency (EMA), which included guidance on planned TH104, the Company’s lead clinical-stage candidate for moderate-to-severe pruritus in primary biliary cholangitis (PBC), Phase 2 and Phase 3 trials.
The Agency supported the strategy presented by the Company and stated that there is no need to conduct additional animal studies and considered human exposure to be adequate to move forward.
Randy Milby, Tharimmune’s CEO, commented, “We are pleased with our interactions with both the FDA and EMA.
“The recent regulatory feedback from the EMA builds on the 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.”
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