Hoth Therapeutics has announced the expansion of its ongoing Phase IIa CLEER-001 clinical trial evaluating HT-001 with the addition of Regis Clinical Research in Miami, Florida, as a new enrolling site.

The move comes as patient demand continues to outpace capacity at existing trial locations, reflecting growing physician and patient interest following positive interim results. The CLEER-001 study is investigating HT-001 for the treatment of dermatologic toxicities associated with Epidermal Growth Factor Receptor inhibitor (EGFRi) cancer therapies.

Approximately 2 lakh patients in the United States initiate EGFR inhibitor therapy annually, many of whom experience severe skin toxicities, including painful rashes, lesions and persistent itching. These adverse effects can lead up to one-third of patients to reduce or discontinue life-saving cancer treatment. Currently, there are no US FDA-approved therapies specifically indicated for this condition.

According to interim data from the CLEER-001 trial, 100 percent of patients in the open-label cohort achieved the primary efficacy endpoint — an ARIGA rash severity score of 1 or below — by week six. No patients required dose reductions or discontinuation of their EGFR inhibitor therapy while receiving HT-001. Additionally, more than 65 percent of participants reported meaningful reductions in pain and itching, and no dose-limiting toxicities have been observed to date.

A case study presented at the American Academy of Dermatology Annual Meeting highlighted complete lesion and symptom resolution within one week of twice-daily HT-001 application in a metastatic breast cancer patient.

The addition of Regis Clinical Research expands the investigational site network and introduces a new South Florida patient population. Hoth said the expansion is expected to accelerate enrollment and support timely completion of the clinical data set required for future regulatory milestones.

Robb Knie, Chief Executive Officer of Hoth Therapeutics, said the company is strengthening trial infrastructure in response to increased enrollment demand and growing interest from oncologists and patients.

The CLEER-001 trial continues to enroll eligible participants across its expanding network of clinical sites.