HCW Biologics Reports Positive Phase 1 Data for HCW9302 in Alopecia Areata
HCW Biologics announced positive preliminary human data from the first two dose cohorts of its dose-escalating Phase 1 clinical trial for HCW9302, an IL-2 based fusion immunotherapeutic, in patients with alopecia areata. All three participants in the second dose cohort (3 micrograms/kg) showed preliminary indications of improvement in Severity of Alopecia Tool (SALT) scores, with a >=25% reduction compared to baseline. The treatment was well tolerated, with no dose-limiting toxicities or significant IL-2-treatment-related adverse effects, including no reported incidence of capillary leak or cytokine release syndrome. The company aims to establish the Recommended Phase 2 Dose by year-end 2026 and plans to explore multi-dose studies for alopecia areata and other autoimmune diseases.
Key Highlights
- HCW9302 Phase 1 trial showed positive preliminary human data for first two dose cohorts in alopecia areata.
- All 3 participants in the second dose cohort (3 micrograms/kg) showed positive clinical response.
- Participants in the second cohort had a >=25% reduction in SALT scores at 4 and/or 9 weeks post-dosing.
- HCW9302 was well tolerated with no dose-limiting toxicities or significant IL-2-related adverse effects.
- No reported incidence of capillary leak, cytokine release syndrome, or increased blood eosinophil counts.
- Company projects to establish the Recommended Phase 2 Dose by year-end 2026.
- Potential expansion to other autoimmune diseases like vitiligo, atopic dermatitis, and ALS in Phase 2 studies.
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