Soterios Pharma Announces Positive Topline Results from Phase II Study of STS-01 in the Treatment of Mild / Moderate Alopecia Areata

• Once-daily topical treatment of mild / moderate alopecia areata (AA) with 1% STS-01 met the primary efficacy endpoint of >30% Severity of Alopecia Tool (SALT) score improvement compared to patients receiving placebo (p<0.0096)
• Multiple secondary endpoints met with significant total hair regrowth across the 1% and 2% dose groups
• STS-01 was well tolerated with no major adverse events
• STS-01 has the potential to become the first approved therapy and standard of care for mild / moderate alopecia areata, (SALT score <50), which represents over half of the estimated 800,000 AA patients in the US

LONDON, May 30, 2024 /PRNewswire/ -- Soterios Pharma, a privately held clinical-stage pharmaceutical company, today announced positive topline results from its randomised, placebo-controlled, multi-dose Phase II trial evaluating STS-01 as a treatment for mild / moderate AA.

At 24 weeks, 75.9% of patients treated with once-daily topical dosing of 1% STS-01 met the primary efficacy endpoint (achieving >30% improvement in SALT score) compared to 36.7% receiving placebo (p<0.0096).  In addition, 19% and 27% of patients on 1% and 2% STS-01, respectively, achieved total hair regrowth (SALT 0), compared to 3% receiving placebo with a clear dose response identified.  STS-01 was well tolerated with no major adverse events. Complete study results are expected to be presented at a future medical meeting.

Arash Mostaghini, Associate Professor of Dermatology at Brigham & Women's Hospital, said,
"These results are extremely encouraging. They validate the potential for STS-01 to provide mild-to- moderate alopecia sufferers with a safe and effective treatment for this debilitating condition. I am also excited by the prospect of targeting total hair regrowth in this patient group."

Mild / moderate alopecia areata (less than 50% hair loss / SALT score <50), represents over half of the 800,000 AA patients in the US¹ and is associated with a significant disease burden, including depression and anxiety. The impact on quality of life for mild / moderate patients is equivalent to those with severe AA² and yet no approved therapies exist for these patients.

David Fleet, CEO of Soterios Pharma, said, "This data gives us clarity and confidence in moving into late-stage clinical development for this product. We thank all the patients, investigators and healthcare staff who participated in this study."

About Soterios Pharma

Soterios Pharma is a UK-based clinical-stage life sciences company, which is focused on developing and commercialising medicines for dermatology diseases with major unmet needs. https://www.soteriospharma.com

About the Phase II Trial

The randomised, placebo-controlled, multi-dose Phase II trial evaluated the safety and efficacy of STS-01 in the treatment of mild / moderate AA when applied for 24 weeks.  A total of 158 participants were randomised to receive one of four doses of STS-01 (0.25%, 0.5%, 1% or 2%) or placebo, with effect being measured based on improvement in the SALT score.

About STS-01

The product builds on a mechanism with a well-established safety profile in dermatology, and works through modulating the inflammatory response and the proliferation of T-cells by disruption of the signalling pathways.  There is extensive preclinical and clinical evidence to support its efficacy and safety profile in AA.

1. Mostaghimi, A., et al, JAMA Dermatol. 2023 Apr 1;159(4):411-418
2. Gelhorn et al., Dermatol Ther (Heidelb) (2022) 12:989–997

Soterios Pharma contacts:

Mark Brimble
[email protected]