Hoth Therapeutics added Regis Clinical Research in Miami, Florida, as a new enrolling site for its CLEER‑001 Phase IIa study, expanding the trial’s geographic footprint and addressing growing enrollment demand.
Interim results from the open‑label cohort show that 100 % of patients achieved the primary endpoint of an ARIGA rash severity score of ≤1 by week six, with no dose reductions or discontinuations and over 65 % reporting meaningful pain or itch relief. These outcomes underscore the therapy’s strong safety profile and potential to fill an unmet need for patients receiving EGFR inhibitor cancer treatments.
CEO Robb Knie said, “The addition of Regis Clinical Research is a direct response to the acceleration we are seeing in enrollment demand. The data speaks for itself. Patients and oncologists are taking notice — and we are building the infrastructure to meet that demand and deliver the full clinical readout this program deserves.” He added, “These results are a significant milestone, underscoring HT‑001’s potential to transform patient care by mitigating debilitating skin toxicities while maintaining critical cancer treatments. Our data highlight HT‑001’s strong safety profile and the potential for it to set a new standard of care in this underserved area.”
Hoth remains a clinical‑stage company with no revenue to date but maintains a robust liquidity position, reporting a high current ratio, no debt, and a strong cash reserve. The company’s financial profile is classified as distressed, reflecting the high risk associated with early‑stage development, yet its cash runway supports continued clinical progress.
The therapy targets EGFR inhibitor–induced skin toxicities, a side effect experienced by more than 200,000 Americans who begin EGFR inhibitor therapy each year. With no FDA‑approved treatments currently available, HT‑001 could capture a sizable market if the Phase IIa results translate into regulatory approval.
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