Ascletis Secures FDA Approval for ASC50 to Treat Psoriasis: A New Hope for Patients
Ascletis Pharma Inc., a leading biotechnology company, has recently announced exciting news regarding its investigational drug candidate, ASC50. This innovative oral small molecule specifically targets interleukin-17 (IL-17), a significant contributor to various autoimmune and inflammatory diseases including psoriasis. With the U.S. Food and Drug Administration’s (FDA) clearance of its investigational new drug (IND) application, Ascletis is set to initiate a Phase I clinical trial for ASC50, marking a pivotal step in its mission to provide effective treatments for patients suffering from this chronic skin condition.
Psoriasis, characterized by red, scaly patches on the skin, affects millions worldwide. Traditional treatments often have limitations in efficacy and safety, prompting the need for new therapeutic options. ASC50 stands out due to its unique formulation and mechanism of action. Initial preclinical studies show that, following oral administration in non-human primates, ASC50 displayed a higher drug exposure, extended half-life, and lower clearance in comparison to existing oral IL-17 inhibitors currently undergoing clinical trials. Such results suggest that it could potentially be a best-in-class treatment for psoriasis.
In addition to its favorable pharmacokinetic properties, ASC50 has demonstrated strong efficacy in animal models of psoriasis. These promising findings suggest that the oral dosage form of ASC50 may provide patients with a more convenient treatment option, requiring daily administration as opposed to more complex regimens associated with existing therapies.
The Phase I trial is designed as a randomized, double-blind, placebo-controlled study, enrolling participants diagnosed with mild-to-moderate plaque psoriasis. Dosing is anticipated to commence in the third quarter of 2025 across various clinical sites in the United States, as Ascletis seeks to confirm the safety and efficacy of ASC50 in human subjects.
Dr. Jinzi Jason Wu, Founder, Chairman, and CEO of Ascletis, expressed his enthusiasm regarding the IND clearance, calling it a significant milestone in the company’s efforts to address the unmet medical needs in autoimmune disorders. He mentioned, “The IND clearance of ASC50 marks a new milestone for Ascletis in autoimmune and inflammatory diseases. We are continuing to work on differentiated agents including oral drugs and once-monthly or less frequent subcutaneously injectables to address unmet medical needs in multiple key therapeutic areas.”
Ascletis has built a reputation as an innovative player in the biotech space, with a focus on research and development activities spanning the entire drug development spectrum—from discovery to GMP manufacturing. With a robust pipeline that includes several clinical-stage drug candidates targeting metabolic diseases, the firm is committed to leveraging cutting-edge technology and scientific expertise to transform patient care.
As the company prepares for its forthcoming clinical trial, stakeholders in the health sector are looking forward to the therapeutic potential of ASC50. The ongoing research not only represents hope for current psoriasis patients but also exemplifies greater advancements in the field of autoimmune disease therapies.
For more details about Ascletis and its ongoing projects, you can visit their official website at www.ascletis.com. As the clinical development of ASC50 progresses, updates will be crucial for patients seeking effective treatment options. The completion of this Phase I trial could ultimately pave the way for broader clinical applications and improved health outcomes for those living with psoriasis.
Psoriasis, characterized by red, scaly patches on the skin, affects millions worldwide. Traditional treatments often have limitations in efficacy and safety, prompting the need for new therapeutic options. ASC50 stands out due to its unique formulation and mechanism of action. Initial preclinical studies show that, following oral administration in non-human primates, ASC50 displayed a higher drug exposure, extended half-life, and lower clearance in comparison to existing oral IL-17 inhibitors currently undergoing clinical trials. Such results suggest that it could potentially be a best-in-class treatment for psoriasis.
In addition to its favorable pharmacokinetic properties, ASC50 has demonstrated strong efficacy in animal models of psoriasis. These promising findings suggest that the oral dosage form of ASC50 may provide patients with a more convenient treatment option, requiring daily administration as opposed to more complex regimens associated with existing therapies.
The Phase I trial is designed as a randomized, double-blind, placebo-controlled study, enrolling participants diagnosed with mild-to-moderate plaque psoriasis. Dosing is anticipated to commence in the third quarter of 2025 across various clinical sites in the United States, as Ascletis seeks to confirm the safety and efficacy of ASC50 in human subjects.
Dr. Jinzi Jason Wu, Founder, Chairman, and CEO of Ascletis, expressed his enthusiasm regarding the IND clearance, calling it a significant milestone in the company’s efforts to address the unmet medical needs in autoimmune disorders. He mentioned, “The IND clearance of ASC50 marks a new milestone for Ascletis in autoimmune and inflammatory diseases. We are continuing to work on differentiated agents including oral drugs and once-monthly or less frequent subcutaneously injectables to address unmet medical needs in multiple key therapeutic areas.”
Ascletis has built a reputation as an innovative player in the biotech space, with a focus on research and development activities spanning the entire drug development spectrum—from discovery to GMP manufacturing. With a robust pipeline that includes several clinical-stage drug candidates targeting metabolic diseases, the firm is committed to leveraging cutting-edge technology and scientific expertise to transform patient care.
As the company prepares for its forthcoming clinical trial, stakeholders in the health sector are looking forward to the therapeutic potential of ASC50. The ongoing research not only represents hope for current psoriasis patients but also exemplifies greater advancements in the field of autoimmune disease therapies.
For more details about Ascletis and its ongoing projects, you can visit their official website at www.ascletis.com. As the clinical development of ASC50 progresses, updates will be crucial for patients seeking effective treatment options. The completion of this Phase I trial could ultimately pave the way for broader clinical applications and improved health outcomes for those living with psoriasis.
Topics Health）
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