Hoth Therapeutics, Inc, a biopharmaceutical company focused on creating new treatments, has submitted a Clinical Trial Application (CTA) to the European Medicines Agency (EMA) as part of its plan to expand the Phase II study of HT-001. This experimental topical treatment is meant to help with skin side effects that often happen when patients use Epidermal Growth Factor Receptor inhibitors (EGFRi), which are commonly used in cancer treatments.

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This latest step is a major achievement in the company’s overall strategy to develop treatments worldwide. It also helps Hoth become a stronger player in the oncology support area, as there are currently no approved therapies for this specific type of skin problem. If the EMA approves the application, Hoth expects to start enrolling patients at European trial sites in early 2026. This will build on the progress already being made in the United States, where patient recruitment is happening right now.

Robb Knie, Chief Executive Officer of Hoth Therapeutics, talked about the recent submission by emphasizing the importance of expanding clinical operations into Europe. He explained that skin side effects from EGFRi therapies remain a big problem for cancer patients, and with no approved treatments available from either the FDA or EMA, HT-001 has the potential to be a very important new option. Knie also mentioned that taking this step forward in Europe not only helps the company’s research but also has the potential to improve patients’ lives and offer value to investors.

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Looking ahead, Hoth expects to get a response from the EMA in the coming months, with the first trials expected to start at sites in three European countries. More sites across the EU are already being planned to help speed up patient recruitment.

Meanwhile, the U.S.-based Phase 2a study continues to look at the safety, tolerability, and effectiveness of HT-001 in patients who are experiencing skin problems from EGFRi treatments.

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