Tharimmune, Inc. (NASDAQ: THAR) saw a significant rise in its stock price, climbing by 159.40% to $5.24 after receiving encouraging feedback from the European Medicines Agency (EMA). This surge follows a successful Scientific Advice meeting with the EMA, which provided critical guidance on the next steps for the company’s lead clinical-stage candidate, TH104, in the treatment of moderate-to-severe pruritus associated with primary biliary cholangitis (PBC).
Promising Guidance for TH104 Development
TH104 is a unique treatment candidate, utilizing nalmefene embedded in a transdermal buccal film designed to adhere to the inside of the mouth. It targets multiple liver-related and pruritogenic inflammatory conditions. During the discussions with the EMA, the focus was primarily on both Phase 2 and Phase 3 clinical trials of TH104. The agency endorsed the company’s plan to proceed with a hybrid application under Article 10(3), which allows referencing non-clinical and certain safety data from previously approved products.
Regulatory Endorsement of Clinical Strategy
The EMA provided positive feedback on the non-clinical data, affirming that additional animal studies are unnecessary, and existing human exposure data are sufficient to proceed. Moreover, the design of the proposed Phase 2 study was deemed largely acceptable, though the agency offered comments for refinement. Additionally, the EMA provided preliminary advice on the design of a potential Phase 3 trial, laying the foundation for future clinical progress.
A Milestone in Advancing TH104
This regulatory approval marks a significant milestone for Tharimmune, building on earlier successful interactions with the U.S. Food and Drug Administration (FDA). In order to assess TH104’s safety, tolerability, and effectiveness in lowering persistent pruritus, the business intends to start a Phase 2 multiple-ascending dosage research. Tharimmune (THAR) is still dedicated to offering patients with PBC cutting-edge treatments.
In order to further this potential treatment, the business will keep working with regulatory bodies in the US and Europe, and topline results from the research is anticipated in 2025.
