EQ101 demonstrates favorable efficacy, tolerability for treatment of alopecia areata

Key takeaways:

• 20% of subjects that completed the study achieved a Severity of Alopecia Tool score of less than or equal to 20.
• 98.9% of adverse events were grade 1 or 2.

Equillium announced positive topline data from its phase 2, single-dose, proof-of-concept study of EQ101 for the treatment of adults with moderate, severe or very severe alopecia areata, according to a press release.

Administered intravenously or subcutaneously, EQ101 is a first-in-class, selective, tri-specific inhibitor of interleukin-2, IL-9 and IL-15. The study results show that EQ101 is effective and tolerable with no serious adverse events in this indication.

“We are very pleased with these positive clinical results, indicating EQ101 to be well tolerated and clinically efficacious in alopecia areata patients with significant hair loss,” Maple Fung, MD, chief medical officer at Equillium, said in the release.

Thirty-six subjects with at least 35% scalp hair loss due to alopecia areata (AA) were enrolled in the study, 25 of which completed the study. Five of the 11 discontinuations were due to adverse events.

Of the 25 subjects that completed 24 weeks of treatment, five achieved a Severity of Alopecia Tool score of less than or equal to 20, meaning the subjects concluded the study with only 20% scalp hair loss or less. None of the eight patients in the very severe group achieved this score. Overall, patients saw a 13.5% improvement in their hair growth from baseline.

According to the study, patients treated with EQ101 did not experience changes in their laboratory work such as liver function, cholesterol, coagulation and other safety concerns. Almost all (98.9%) adverse events were grade 1 or 2. The most common adverse events were upper respiratory tract infection, headache and fatigue. The two grade 3 events considered related to treatment were transient lymphocytopenia and fatigue.

According to Fung, Equillium plans to investigate EQ101’s utility across AA disease severity subgroups, especially moderate disease.