Hoth Therapeutics Secures Spain Approval for HT-001 Phase 2a, Reports 65% Symptom Relief
Hoth Therapeutics secured Spanish regulatory approval for its randomized, placebo-controlled Phase 2a CLEER trial of HT-001 evaluating EGFR inhibitor skin toxicities. Interim data show rash severity reduced to ARIGA ≤1 by Week 6, over 65% of patients reported pain and itch relief, and no cancer therapy disruptions.
1. Spain Authorization
Hoth Therapeutics obtained regulatory authorization from Spanish authorities to initiate its Phase 2a CLEER trial evaluating HT-001, marking the first European approval for this study. This clearance allows for trial execution in multiple Spanish oncology centers under a randomized, placebo-controlled, dose-ranging design.
2. Interim Efficacy Results
Interim data show that by Week 6 all patients achieved the primary endpoint of ARIGA scores ≤1, indicating clinically manageable rash. Additionally, over 65% of participants reported significant reductions in pain and itching associated with EGFR inhibitor therapies.
3. Safety Profile
No patients required dose reduction or discontinuation of their underlying EGFR inhibitor cancer therapy, and no treatment-limiting adverse events were observed. These findings underscore the potential of HT-001 to maintain uninterrupted cancer treatment schedules.
4. Next Steps and Expansion
Following the successful Spanish authorization and promising interim results, Hoth plans to expand the CLEER trial across additional European regions. This momentum supports the company’s strategy to develop HT-001 as a critical supportive care therapy in oncology.