Equillium announces data from EQ101 study

Equillium announced topline data from its Phase 2, single dose, proof-of-concept, or PoC, study of EQ101 in adult patients with moderate, severe or very-severe alopecia areata, or AA, an autoimmune disease driven by an immune cell attack of the hair follicles that causes hair loss. The primary objectives of the study were to evaluate the safety and tolerability profile of EQ101, as well as signs of efficacy using Severity of Alopecia Tool, or SALT, scores, where a score of 100 represents total scalp hair loss and a score of 0 represents no scalp hair loss. Results from the study demonstrated a favorable safety and tolerability profile with no serious adverse events, or SAEs, and improvements in SALT scores above the published historically low placebo response rates. Of all subjects that completed 24 weeks of treatment, 20% achieved a SALT score of less than or equal to 20 by week 24. Of those subjects with moderate to severe AA at baseline that completed 24 weeks of treatment, 29% achieved a SALT score of less than or equal to 20 by week 24, and a mean SALT improvement from baseline of 18%. Throughout 24 weeks of treatment and 4 weeks of follow up, EQ101 was well tolerated with no SAEs and no notable changes in safety laboratory, electrocardiogram, vital signs, or physical exam findings were reported. The majority of adverse events were Grade 1 or 2, with the most common being upper respiratory tract infection, headache and fatigue. The two Grade 3 events in two subjects considered related to study treatment were a case of transient lymphocytopenia and fatigue.