Soterios Pharma is eyeing phase 3 after a 1% dose of the company's alopecia areata cream improved severity of the condition, hitting the main goal of a mid-stage trial.
The U.K.-based biotech hasn’t shared much detail about the science behind the non-steroidal 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 administered. 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 cohorts, but said details 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, compared to just 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 areata, which the company said represents over half of the estimated 800,000 U.S. patients with the hair loss autoimmune disease.
Eli Lilly and Incyte's blockbuster Olumiant is already approved for adults with severe alopecia areata—defined as 50% or greater scalp hair loss—while Pfizer’s Litfulo is approved for adolescents. Soterios is keen to set itself up as an alternative to those JAK inhibitors.
“Whilst the JAK inhibitors have the potential to offer a new treatment option for severe patients, their use more broadly will be limited by concerns with their side effect profiles (and price),” the British biotech claimed on its website.