Hoth Therapeutics (NASDAQ: HOTH) has announced 100% clinical response and approximately 50% reduction in disease severity in the open-label pharmacokinetic (PK) cohort of its ongoing CLEER-001 clinical trial evaluating HT-001 in cancer patients receiving EGFR inhibitor therapy.
According to Hoth, the primary endpoint of CLEER-001 assessed disease severity using the Acneiform Rash Investigator Global Assessment (ARIGA) scale. In the open-label PK cohort, mean ARIGA scores improved from 1.67 at baseline to 0.83 at week six, representing an approximate 50% reduction in severity. Importantly, all evaluable patients reached ARIGA ≤1 by week six, placing the entire evaluable cohort within the low-severity disease range. Improvements were observed as early as week three and were maintained through week six, demonstrating both rapid onset and durability of response.
In a statement, Robb Knie, CEO of Hoth, commented, “These results represent a meaningful milestone for HT-001. Seeing 100% clinical response in the open-label PK cohort, along with a ~50% reduction in disease severity and additional improvements in oncology toxicity and patient-reported symptoms, underscores the potential of HT-001 to improve the treatment experience for cancer patients receiving EGFR inhibitors. We are encouraged by the breadth and consistency of these findings as the CLEER-001 trial continues.”
