On April 1, 2026 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company, reported positive clinical results from its ongoing HT-001 program, including achievement of the primary efficacy endpoint in interim analysis, with patients reaching an ARIGA rash severity score of ≤1 by week six.
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In addition to the strong results in Ariga score, HT-001 demonstrated strong patient benefit across multiple clinically meaningful measures. Over 65% of patients reported meaningful reductions in pain and itching, supporting HT-001’s potential to significantly improve quality of life for patients suffering from dermatologic toxicities, including those associated with epidermal growth factor receptor inhibitor (EGFR) cancer therapies.
Importantly, zero patients required dose reduction or discontinuation of their EGFR inhibitor therapy while receiving HT-001, highlighting the potential for HT-001 to manage dermatologic side effects without interfering with life-saving cancer treatments.
HT-001 was also well tolerated, with no treatment discontinuations reported.
Pharmacokinetic (PK) analysis further demonstrated that HT-001 achieves approximately 99% lower systemic exposure compared to FDA-approved oral therapies, supporting a targeted delivery profile designed to maximize local efficacy while minimizing systemic side effects.
Building on these positive results, Hoth has received regulatory approval in Hungary, enabling expansion of the Phase 2 clinical trial into Europe. The Company anticipates additional regulatory approvals in Spain and Poland, with site activations expected in the near term. In the United States, an additional clinical site is expected to be activated, further accelerating patient enrollment and data generation.
"The achievement of these interim results, combined with strong patient-reported outcomes and the ability to maintain uninterrupted cancer therapy, represents a meaningful advancement for HT-001," said Robb Knie Chief Executive Officer of Hoth Therapeutics. "With over 65% of patients reporting reductions in pain and itching, along with a favorable safety profile and expanding global clinical footprint, we believe HT-001 is well positioned as a differentiated therapy addressing a critical unmet need in oncology supportive care."
Dermatologic toxicities remain a significant challenge for patients undergoing cancer treatment, often leading to discomfort, reduced quality of life, and in some cases treatment modification or discontinuation. HT-001’s ability to demonstrate primary endpoint achievement, meaningful symptom improvement, and zero disruption to EGFR inhibitor therapy may represent a compelling advancement over existing treatment options.
(Press release, Hoth Therapeutics, APR 1, 2026, View Source [SID1234664133])