{"id":26837,"date":"2024-05-29T23:05:00","date_gmt":"2024-05-29T23:05:00","guid":{"rendered":"https:\/\/www.prnasia.com\/story\/archive\/4424780_AE24780_0"},"modified":"2024-05-29T23:05:00","modified_gmt":"2024-05-29T23:05:00","slug":"soterios-pharma-announces-positive-topline-results-from-phase-ii-study-of-sts-01-in-the-treatment-of-mild-moderate-alopecia-areata","status":"publish","type":"post","link":"https:\/\/transmediavictoria.net.au\/?p=26837","title":{"rendered":"Soterios Pharma Announces Positive Topline Results from Phase II Study of STS-01 in the Treatment of Mild \/ Moderate Alopecia Areata"},"content":{"rendered":"\n<ul type=\"disc\">\n<li>Once-daily topical treatment of mild \/ moderate alopecia areata (AA) with 1% STS-01 met the primary efficacy endpoint of &gt;30% Severity of Alopecia Tool (SALT) score improvement compared to patients receiving placebo (p&lt;0.0096)<\/li>\n<li>Multiple secondary endpoints met with significant total hair regrowth across the 1% and 2% dose groups<\/li>\n<li>STS-01 was well tolerated with no major adverse events<\/li>\n<li>STS-01 has the potential to become the first approved therapy and standard of care for&nbsp;mild \/ moderate alopecia areata, (SALT score &lt;50), which represents over half of the estimated 800,000 AA patients in the US<\/li>\n<\/ul>\n<p><span class=\"xn-location\">LONDON<\/span>, May 30, 2024 \/PRNewswire\/ &#8212; 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<p>At 24 weeks, 75.9% of patients treated with once-daily topical dosing of 1% STS-01 met the primary efficacy endpoint (achieving &gt;30% improvement in SALT score) compared to 36.7% receiving placebo (p&lt;0.0096). &nbsp;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. &nbsp;STS-01 was well tolerated with no major adverse events. Complete study results are expected to be presented at a future medical meeting.<\/p>\n<p>Arash Mostaghini, Associate Professor of Dermatology at Brigham &amp; Women&#8217;s Hospital, said, <br \/>&quot;These results are extremely encouraging. They validate the potential for STS-01 to provide mild-to- moderate&nbsp;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.&quot;<\/p>\n<p>Mild \/ moderate alopecia areata (less than 50% hair loss \/ SALT score &lt;50), represents over half of the 800,000 AA patients in the US<sup>1<\/sup> 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 AA<sup>2<\/sup> and yet no approved therapies exist for these patients.<\/p>\n<p><span class=\"xn-person\">David Fleet<\/span>, CEO of Soterios Pharma, said, &quot;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.&quot;<\/p>\n<p><b>About Soterios Pharma<\/b><\/p>\n<p>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. <a href=\"https:\/\/www.soteriospharma.com\/\" target=\"_blank\" rel=\"nofollow noopener\">https:\/\/www.soteriospharma.com<\/a><\/p>\n<p><b>About the Phase II Trial<\/b><\/p>\n<p>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.&nbsp; 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<p><b>About STS-01<\/b><\/p>\n<p>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. &nbsp;There is extensive preclinical and clinical evidence to support its efficacy and safety profile in AA.<\/p>\n<ol type=\"1\">\n<li>Mostaghimi, A., et al, JAMA Dermatol. 2023 <span class=\"xn-chron\">Apr 1<\/span>;159(4):411-418<\/li>\n<li>Gelhorn et al., Dermatol Ther (Heidelb) (2022) 12:989\u2013997<\/li>\n<\/ol>\n<p><b>Soterios Pharma contacts:<\/b><\/p>\n<p><span class=\"xn-person\">Mark Brimble<\/span><br \/><a href=\"mailto:info@soteriospharma.com\" target=\"_blank\" rel=\"nofollow noopener\">info@soteriospharma.com<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Once-daily topical treatment of mild \/ moderate alopecia areata (AA) with 1% STS-01 met the primary efficacy endpoint of &gt;30% Severity of Alopecia Tool (SALT) score improvement compared to patients receiving placebo (p&lt;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 [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[],"class_list":["post-26837","post","type-post","status-publish","format-standard","hentry","category-business-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - 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