HT-001 Addresses Skin Toxicities in Patients With Cancer

Hoth Therapeutics reported encouraging interim safety and efficacy results in a phase 2a clinical trial of HT-001, a topical gel designed to treat skin toxicities.

Treatment with HT-001, designed to address skin toxicities linked to epidermal growth factor receptor Inhibitors (EGFRi) in patients with cancer, elicited encouraging interim safety and efficacy results in the phase 2a CLEER-001 clinical trial, according to a press release from Hoth Therapeutic Inc., a leading biopharmaceutical company focused on patient-centric solutions.

In the phase 2a trial, investigators reported that 100% of patients evaluated achieved the primary efficacy end point of an Acneiform Rash Investigator Global Assessment Scale (ARIGA) score of 1 or less. The ARIGA scale ensures precise measurement and assessment of skin toxicity improvements and was developed in collaboration with onco-dermatology experts.

Data outcomes showed a significant skin toxicity improvement by the six-week mark, demonstrating remarkable success, according to the press release. A total of 66% of patients reported reduced pain and itching scores, which further underscores an enhancement in patient quality of life. Moreover, the cancer treatment's full therapeutic effect was preserved, as all patients maintained their full EGFRi dosage. The release also shared that this improvement was notable compared with past reports which sometimes resulted in widespread dose reductions or treatment halts due to skin-related side effects.

In regard to safety, there were no treatment-related side effects reported, reaffirming the tolerability of HT-001.

“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,” Robb Knie, Chief Executive Officer of Hoth Therapeutics, stated in the press release.

As the trial remains ongoing, investigators aiming to understand the therapeutic effect of HT-001 in patients who develop acneiform rash undergoing EGFRI therapy using the ARIGA scale and the safety of HT-001 during treatment. On the trial, HT-001 gel will be applied by participants once per day for six weeks, applying the study drug to each area affected with cutaneous toxicity up to 30% body surface area involvement, including skin, scalp, and nails. During this time, acneiform rash or other skin disorders induced by EGFRI therapy will be evaluated to measure severity of rash, pain and itching (pruritus), as well as the change in quality of life.

This will be assessed over two periods of the study. On the first period of the study, all patients will receive HT-001 topical gel with the active ingredient; this is open-label (unblinded) and investigators will measure the pharmacokinetics of HT 001 gel. In the second period though, patients will be randomized to receive one of three concentrations of HT-001 or placebo; this second period is a randomized, parallel and blinded, in which three dose strengths of HT-001 gel will be administered. Investigators will subsequently compare HT-001 with placebo to best understand the agent's treatment effect.

Overall, the dose effect, the application site safety assessments and therapeutic effects will be assessed based on the primary and secondary end points.

“These interim findings align with a recent case report of rapid resolution of EGFRi-induced skin conditions using HT-001,” Knie emphasized. “As the study progresses, we anticipate further validating these results and are excited about the potential impact HT-001 could have on patient outcomes.”

As patient enrollment continues, the full trial results are awaited.

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