Hoth Therapeutics, Inc. (NASDAQ: HOTH) has announced positive interim results from its Phase 2a clinical trial of HT-001, a topical gel designed to combat skin toxicities associated with Epidermal Growth Factor Receptor Inhibitors (EGFRi) in cancer patients. The data revealed a 100% success rate in achieving the primary efficacy endpoint.
The open-label portion of the CLEER-001 trial demonstrated that all patients achieved an Acneiform Rash Investigator Global Assessment Scale (ARIGA) score ≤1 by week six, indicating significant improvement in skin toxicity. Furthermore, 66% of patients reported a reduction in pain and itching. Importantly, all patients maintained their full EGFRi dosage, preserving the therapeutic effect of their cancer treatment without dose reductions or interruptions typically caused by severe skin-related side effects.
Key Findings from the CLEER-001 Trial
The CLEER-001 trial utilized the proprietary ARIGA scale, developed in collaboration with onco-dermatology experts, to ensure precise measurement and assessment of skin toxicity improvements. The trial's success highlights HT-001's potential to mitigate debilitating skin toxicities while maintaining critical cancer treatments.
Robb Knie, CEO of Hoth Therapeutics, stated, "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."
Addressing a Critical Unmet Need
Epidermal Growth Factor Receptor Inhibitors (EGFRi) are a key component in many cancer therapies, but they often cause severe skin toxicities, including skin inflammation, infection, pruritus, and dryness. Studies indicate that 45% to 100% of patients treated with EGFRi experience these adverse skin reactions, sometimes leading to dose reductions or treatment discontinuation, which reduces the effectiveness of the cancer therapies.
HT-001 is designed to address this critical unmet need by reducing skin toxicity without compromising the efficacy of the cancer treatment. The absence of reported treatment-related adverse effects further supports HT-001's favorable safety profile.
Future Directions
Hoth Therapeutics is committed to advancing HT-001 through clinical development and intends to submit a new drug application via the 505(b)(2) regulatory pathway. The company anticipates further validating these results as the study progresses and is optimistic about the potential impact HT-001 could have on patient outcomes.
Knie added, "These interim findings align with a recent case report of rapid resolution of EGFRi-induced skin conditions using HT-001." The company is dedicated to developing innovative therapies that improve the quality of life for patients facing serious health challenges.
