Zinger Key Points
- 100% of patients in the trial achieved an ARIGA score ≤1, showing significant skin toxicity improvements by six weeks.
- 66% reported reduced pain and itching, enhancing quality of life while maintaining full EGFRi dosages.
On Tuesday, Hoth Therapeutics, Inc. HOTH shared interim safety and efficacy results from its Phase 2a clinical trial of HT-001, designed to address skin toxicities linked to Epidermal Growth Factor Receptor Inhibitors in cancer patients.
Data from the open-label portion of the CLEER-001 trial demonstrated:
- 100% of patients achieved the primary efficacy endpoint of an ARIGA score ≤1, showing significant skin toxicity improvement by the six-week mark.
- 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—a notable improvement compared to past reports showing widespread dose reductions or treatment halts due to skin-related side effects.
The trial uses the proprietary Acneiform Rash Investigator Global Assessment Scale, developed in collaboration with onco-dermatology experts. The scale ensures precise measurement and assessment of skin toxicity improvements.
Robb Knie, CEO of Hoth Therapeutics, said, “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.”
No treatment-related adverse effects have been reported, reaffirming HT-001’s excellent tolerability.
“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.”
Last month, Hoth Therapeutics entered into an exclusive patent license agreement with the U.S. Department of Veterans Affairs (VA).
Under the terms of the agreement, Hoth Therapeutics will have exclusive rights to develop, market, and commercialize products and processes derived from the licensed patents.
The VA and Emory University have granted Hoth this license to develop the technology further.
Price Action: HOTH stock is up 246.5% at $2.84 at last check Tuesday.
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