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Shares of Hoth Therapeutics HOTH skyrocketed 178.2% on Tuesday after the company announced positive interim safety and efficacy results from a mid-stage study of its lead candidate, HT-001, which is being developed to address skin toxicities linked to cancer patients undergoing treatment with EGFR inhibitors.
Per the data readout from the ongoing phase IIa study, all patients treated with the candidate achieved the primary efficacy endpoint of an ARIGA score ≤1, showing significant skin toxicity improvement by the six-week mark. Hoth's proprietary ARIGA scale, developed in partnership with onco-dermatology experts, provides an accurate tool for measuring and evaluating improvements in skin toxicity.
Additionally, 66% of patients treated withHT-001 reported reduced pain and itching scores, which significantly improved their quality of life. Importantly, all patients retained their full EGFR inhibitor dosage, ensuring the cancer treatment's complete therapeutic efficacy. This is a significant improvement over previous reports that highlighted frequent dose reductions or treatment interruptions caused by skin-related side effects.
In the past three months, HOTH shares have rallied 186.6% against the industry’s 10% decline.
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Based on the encouraging interim results, Hoth believes that HT-001 has significant potential to become the new standard of care in treating severe skin toxicities associated with EGFR inhibitors, without interrupting the treatment process.
Initial data suggest that the candidate was overall well-tolerated in the study and no treatment-related adverse events were reported.
HOTH’s Future Development Plans for HT-001
Hoth states that this interim data supports a recent case report of rapid resolution of EGFR inhibitor-induced skin conditions using HT-001. In September 2024, the company announced positive data from the treatment of the first patient with the candidate who was experiencing papulopustular eruptions, a common and debilitating side effect of EGFR inhibitor therapy in cancer patients.
As the phase IIa study progresses, management expects to report more data that further validate the therapeutic benefit of HT-001 to address skin toxicities linked to this patient population. Meanwhile, Hoth continues to enroll patients in the mid-stage study.
Hoth’s Developmental Pipeline Beyond HT-001
Apart from HT-001, Hoth’s clinical pipeline consists of another investigational candidate, BioLexa, which is currently being developed in a separate early-stage study for the treatment of atopic dermatitis.