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Ascletis Announces U.S. FDA Clearance of IND Application for Its Oral Small Molecule IL-17 Inhibitor, ASC50, for the Treatment of Psoriasis
Ascletis Pharma Inc. (HKEX:1672, "Ascletis") announces the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for a Phase I trial for ASC50 for the treatment of mild-to-moderate plaque psoriasis. ASC50 is an in-house discovered and developed oral small molecule inhibitor targeting interleukin-17 (IL-17), an important biologically and commercially validated target for multiple autoimmune and inflammatory diseases, including psoriasis.
About this update from Ascletis Pharma, Inc.
[{"type":"text","content":"-- ASC50 is an in-house discovered and developed oral small molecule interleukin-17 (IL-17) inhibitor for the treatment of multiple autoimmune and inflammatory diseases, including psoriasis.","length":190,"tagName":"p","attribs":{}},{"type":"text","content":"-- Following oral dosing in non-human primates, ASC50 demonstrated higher drug exposure, longer half-life and lower clearance than an oral small molecule IL-17 inhibitor comparator, which is currently in the clinical development.","length":229,"tagName":"p","attribs":{}},{"type":"text","content":"-- Preclinical data, including higher oral exposure, longer half-life and strong efficacy, support ASC50 as a potential best-in-class oral agent for psoriasis. ","length":164,"tagName":"p","attribs":{}},{"type":"text","content":"-- The Company expects to initiate dosing in a Phase I trial in patients with mild-to-moderate plaque psoriasis in the third quarter of 2025.","length":141,"tagName":"p","attribs":{}},{"type":"text","content":"HONG KONG, May 22, 2025 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX:1672, "Ascletis") announces the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for a Phase I trial for ASC50 for the treatment of mild-to-moderate plaque psoriasis. ASC50 is an in-house discovered and developed oral small molecule inhibitor targeting interleukin-17 (IL-17), an important biologically and commercially validated target for multiple autoimmune and inflammatory diseases, including psoriasis.","length":535,"tagName":"p"},{"type":"text","content":"Following oral dosing in non-human primates, ASC50 demonstrated higher drug exposure, longer half-life and lower clearance than an oral small molecule IL-17 inhibitor comparator, which is currently in the clinical development. Furthermore, ASC50 demonstrated strong efficacy in a psoriasis animal model. These preclinical data support ASC50 as a potential best-in-class once-daily oral drug candidate for the treatment of psoriasis.","length":432,"tagName":"p"},{"type":"text","content":"The Phase I clinical trial of ASC50 is a randomized, double-blind, placebo-controlled study and will be conducted at multiple sites in the U.S. Dosing of patients with mild-to-moderate plaque psoriasis is expected to start in the third quarter of 2025.","length":252,"tagName":"p"},{"type":...