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Interim Phase 2a Data: HT-001 Delivers 100% Success in Combating Cancer Treatment Skin Toxicities

Hoth Therapeutics, Inc.’s HT-001 showed promising interim safety and efficacy results from its Phase 2a clinical trial addressing skin toxicities linked to Epidermal Growth Factor Receptor Inhibitors (EGFRi) in cancer patients.

HT-001 topical gel is anticipated to inhibit recruitment and activation of immune cells, reducing inflammation.

Fully 100% of patients in Cohort 1 achieved the primary efficacy endpoint of an Acneiform Rash Investigator Global Assessment Scale (ARIGA) score ≤1, showing significant skin toxicity improvement by the six-week mark in the open-label part of the CLEER-001 trial. In addition, 66% of patients reported reduced pain and itching scores, further enhancing quality of life.

All patients maintained their full EGFRi dosage, preserving the cancer treatment’s full therapeutic effect, the study showed. No treatment-related adverse effects have been reported.

“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,” says Robb Knie, CEO of Hoth Therapeutics, in a news release. “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.”

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

PHOTO CREDIT: DermNet