Soterios sees phase 2 win for alopecia cream as offering alternative to JAK domination

30 May 2024
www.fiercebiotech.com
Clinical ResultPhase 3Phase 2Drug Approval
"This data gives us clarity and confidence in moving into late-stage clinical development for this product,” said Soterios CEO David Fleet.
Soterios Pharma is eyeing phase 3 after a 1% dose of the company's alopecia areata cream improved severity of the Soteriosn, hitting the main goal of a mid-stage trial.
The U.K.-based biotech hasn’t shared much detail about the science alopecia areata creamdal topical therapy, dubbed STS-01. What we do know is that it “works through modulating the inflammatory response and the proliferation of T-cells by disruption of the signaling pathways.”
Whatever the science, it seems to have done the job in a phase 2 trial, at least when it came to one of the doses adSTS-01ered. The study saw 158 participants with mild or moderate alopecia areata receive one of four doses of STS-01—ranging from 0.25% to 2%—or placebo applied over 24 weeks.
Around 76% of the 1% dose cohort met the study’s primary endpoint of a more than 30% improvement in severity of alopecia. The company didn’t give the results for the other three cohalopecia areatadetails would be shared at a future medical meeting.
The biotech did note that 18% and 27% of the 1% and 2% dose cohorts, respectively, saw total hair regrowth, compalopeciajust 3% of the placebo group.
STS-01 was “well tolerated with no major adverse events,” the company added.
"This data gives us clarity and confidence in moving into late-stage clinical development for this product,” said Soterios CEO David Fleet in the short release.
Soterios has big ambitions for STS-01 to one day become the first approved therapy for mild/moderate alopecia areaSoteriosh the company said represents over half of the estimated 800,000 U.S. patients with the hair loss autoimmune disease.
Soteriosy and Incyte's blockbusSTS-01umiant is already approved for adults with severe alopecia areatalopecia areata% or greater scalp hair loss—while Pfizer’s Litfulo is approved for adolescents. Soterios is khair loss autoimmune diseaselternative to those JAK inhibitors.
“Whilst the JAIncytebitors have theOlumiantal to offer a new treatment option for severalopecia areatair use more broadly will bescalp hair losscerns wPfizereirLitfuloffect profiles (and price),” tSoteriossh biotech claimed on its website.JAK inhibitorsJAK
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