Hungary Approves Trial Expansion as HT-001 Meets Primary Endpoint in Interim Analysis

Got story updates? Submit your updates here. ›

Hoth Therapeutics, a clinical-stage biopharmaceutical company, announced positive results from its ongoing HT-001 program, including achievement of the primary efficacy endpoint in interim analysis. Over 65% of patients reported meaningful reductions in pain and itching, and there were zero disruptions to patients' EGFR cancer therapy while receiving HT-001. The company has received regulatory approval in Hungary to expand its Phase 2 clinical trial into Europe.

Why it matters

Dermatologic toxicities remain a significant challenge for cancer patients, often leading to discomfort, reduced quality of life, and treatment modifications 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.

The details

In the interim analysis, HT-001 demonstrated that over 65% of patients reached an ARIGA rash severity score of ≤1 by week six, meeting the primary efficacy endpoint. HT-001 also showed strong patient-reported outcomes, with over 65% of patients reporting meaningful reductions in pain and itching. 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 analysis further demonstrated that HT-001 achieves approximately 99% lower systemic exposure compared to FDA-approved oral therapies.

• On April 1, 2026, Hoth Therapeutics announced the positive clinical results from its ongoing HT-001 program.
• 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.

What they’re saying

What’s next

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.