Shares of Hoth Therapeutics Inc (NASDAQ:HOTH) climbed 5.7% in early Thursday trading after the release of encouraging interim data from the company's ongoing CLEER-001 clinical study. This trial is examining the efficacy and safety of HT-001 in cancer patients who are being treated with epidermal growth factor receptor (EGFR) inhibitors.
In the pharmacokinetic cohort of the open-label trial, which centers on drug exposure and early clinical effects, all evaluable patients showed a clinical response by the sixth week. The severity of disease, as assessed by investigators, was reduced by about half compared to initial measurements. Specifically, scores on the ARIGA scale improved from an average baseline of 1.67 down to 0.83 at Week 6, with every participant achieving a low-severity disease classification.
Secondary outcomes further highlighted beneficial effects, with an approximate 34% improvement noted in oncology toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE), alongside a roughly 37% decrease in patient-reported itching symptoms. The therapy demonstrated a favorable safety profile, with no unanticipated adverse events noted during the evaluation period.
EGFR-directed therapies remain a cornerstone treatment for several major cancers including lung, colorectal, and head-and-neck malignancies; however, their associated treatment-related toxicities often present challenges in maintaining uninterrupted therapy. HT-001 is designed as a supportive-care agent to alleviate these toxicities, thereby improving patient adherence to cancer treatment regimens.
Robb Knie, Chief Executive Officer of Hoth Therapeutics, highlighted the significance of these findings stating, "These results represent a meaningful milestone for HT-001." The company plans to continue the CLEER-001 trial to further evaluate pharmacokinetics, tolerability, and ongoing clinical benefits.