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\u00a0mild \/ moderate alopecia areata, (SALT score <50), which represents over half of the estimated 800,000 AA patients in the US <\/p>\n
LONDON<\/span>, 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.<\/p>\n 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). \u00a0In 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. \u00a0STS-01 was well tolerated with no major adverse events. Complete study results are expected to be presented at a future medical meeting.<\/p>\n Arash Mostaghini, Associate Professor of Dermatology at Brigham & Women’s Hospital, said, 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.<\/p>\n David Fleet<\/span>, 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.”<\/p>\n About Soterios Pharma<\/p>\n 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<\/a><\/p>\n About the Phase II Trial<\/p>\n 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.\u00a0 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.<\/p>\n About STS-01<\/p>\n 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. \u00a0There is extensive preclinical and clinical evidence to support its efficacy and safety profile in AA.<\/p>\n Mostaghimi, A., et al, JAMA Dermatol. 2023 Apr 1<\/span>;159(4):411-418 Gelhorn et al., Dermatol Ther (Heidelb) (2022) 12:989\u2013997 <\/p>\n Soterios Pharma contacts:<\/p>\n Mark Brimble<\/span> <\/p>\n 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\u00a0mild \/ moderate alopecia areata, (SALT score <50), which represents over half of the estimated 800,000 AA patients in the US <\/p>\n LONDON<\/span>, 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.<\/p>\n 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). \u00a0In 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. \u00a0STS-01 was well tolerated with no major adverse events. Complete study results are expected to be presented at a future medical meeting.<\/p>\n Arash Mostaghini, Associate Professor of Dermatology at Brigham & Women’s Hospital, said, 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.<\/p>\n David Fleet<\/span>, 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.”<\/p>\n About Soterios Pharma<\/p>\n 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<\/a><\/p>\n About the Phase II Trial<\/p>\n 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.\u00a0 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.<\/p>\n About STS-01<\/p>\n 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. \u00a0There is extensive preclinical and clinical evidence to support its efficacy and safety profile in AA.<\/p>\n Mostaghimi, A., et al, JAMA Dermatol. 2023 Apr 1<\/span>;159(4):411-418 Gelhorn et al., Dermatol Ther (Heidelb) (2022) 12:989\u2013997 <\/p>\n Soterios Pharma contacts:<\/p>\n
“These results are extremely encouraging. They validate the potential for STS-01 to provide mild-to- moderate\u00a0alopecia 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.”<\/p>\n
info@soteriospharma.com<\/a><\/p>","protected":false},"excerpt":{"rendered":"
“These results are extremely encouraging. They validate the potential for STS-01 to provide mild-to- moderate\u00a0alopecia 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.”<\/p>\n