Soterios Achieves Phase 2 Success for Alopecia Cream as an Alternative to JAK Inhibitors

Soterios Pharma plans to proceed to phase 3 trials after its 1% Alopecia areata cream successfully reduced the severity of the disease, achieving the primary endpoint of the mid-phase trial.

The UK-based biotech has yet to disclose many details about how its non-steroidal topical therapy, STS-01, works. However, it is known that “it operates through modulation of inflammation and T-cell counts and works by disrupting signaling pathways.”

Regardless of the exact mechanism, the phase 2 trial showed promising results for one of the doses tested. One hundred fifty-eight subjects with mild to moderate alopecia areata completed the study, receiving one of four dosing levels of STS-01: 0.25%, 0.5%, 1%, and 2%, or a placebo, over 24 weeks.

The baseline characteristics of the patients included: 76% of patients in the 1% dose cohort experienced a reduction in the severity of alopecia by more than 30% compared to baseline, meeting the primary endpoint of the study. The company has only released results for the initial group and did not report outcomes for the other three groups, stating that patient data will be presented at an upcoming medical conference.

Regarding safety, patients in the 1% and 2% dose cohorts reported total hair regrowth in 18% and 27% of cases, respectively, compared with only 3% in the placebo group. STS-01 was deemed safe, with no serious side effects reported.

“This data provides focus and conviction in progressing to late clinical trials for this product,” Soterios’s CEO David Fleet said in brief remarks.

When STS-01 is completed, Soterios aims for it to be the first therapy to receive formal approval for treating the over 400,000 mild to moderate alopecia areata patients in the U.S., representing over half of the 800,000 people in the country with this autoimmune hair loss disease.

Currently approved drugs for adults with severe alopecia areata, which involves the loss of more than half of the scalp hair, include Olumiant from Eli Lilly and Incyte, and for adolescents, Litfulo from Pfizer. Soterios aims to position itself as an alternative to these JAK inhibitors.

“The JAK inhibitors also hold the prospect of providing a new therapy for severe patients only, as the issues about side effects (as well as price) will place more significant limitations on their use,” the British biotech stated on its website.

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