Ascletis Advances Denifanstat Development Toward NDA Submission
Advancements in Acne Treatment: Denifanstat (ASC40)
In a major stride towards future treatment options for moderate-to-severe acne vulgaris, Ascletis Pharma Inc. has successfully completed its pre-New Drug Application (NDA) consultation with the China National Medical Products Administration (NMPA) regarding denifanstat (ASC40). This significant event marks a pivotal moment for the company as it prepares to submit the NDA shortly, aiming to bring this innovative therapy to patients in need.
Clinical Trial Success: Phase III Findings
The journey of denifanstat (ASC40) through the clinical trial landscape has been marked by impressive results. A Phase III randomized, double-blind, placebo-controlled, multicenter clinical trial has shown that denifanstat met all primary and key secondary endpoints, effectively improving conditions related to moderate-to-severe acne compared to a placebo. This breakthrough showcases not only the efficacy of the treatment but also its favorable safety profile. Specifically, all treatment-emergent adverse events (TEAEs) were mild or moderate, with no serious adverse events reported.
Presentation of Results and Future Plans
The encouraging results from the Phase III study were recently shared through an oral presentation at a prominent dermatology congress. This platform allowed Ascletis to highlight the potential of denifanstat in improving the quality of life for those affected by persistent acne conditions. Following this successful study, the company is poised to submit its NDA for the therapy, ushering in a new era for acne treatment options.
Innovative Research and Development
Ascletis is recognized for its commitment to developing advanced therapeutics for metabolic diseases and other conditions. The company utilizes cutting-edge technologies such as Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) to streamline its drug development process. Denifanstat is a prime example of this innovative approach and represents their dedication to providing first-in-class treatment options.
Licensing and Strategic Partnerships
In a strategic move to enhance its portfolio, Ascletis licensed denifanstat from Sagimet Biosciences Inc., securing exclusive rights within Greater China. This partnership highlights Ascletis' strategy to access and promote novel therapeutics that can address unmet medical needs effectively.
About Ascletis Pharma Inc.
Ascletis Pharma Inc. stands as a fully integrated biotechnology firm focused on the development and commercialization of cutting-edge therapeutics. With a commitment to excellence, the company develops potential best-in-class and first-in-class drugs for various medical conditions. Their lead program, ASC30, showcases their innovative approach with a small molecule GLP-1R agonist designed for flexible administration. Ascletis is publicly traded on the Hong Kong Stock Exchange under the ticker symbol 1672.HK.
Contact Information
For inquiries, please contact:
Peter Vozzo
ICR Healthcare
443-231-0505 (U.S.)
Ascletis Pharma Inc. PR and IR teams
+86-181-0650-9129 (China)
Frequently Asked Questions
What is denifanstat (ASC40) used for?
Denifanstat (ASC40) is being developed for the treatment of moderate-to-severe acne vulgaris.
What did the Phase III study results indicate?
The Phase III study demonstrated that denifanstat met all primary and secondary efficacy endpoints, significantly improving acne conditions compared to placebo.
What is the next step for Ascletis regarding denifanstat?
Ascletis plans to submit a New Drug Application (NDA) for denifanstat to the China NMPA soon after completing the pre-NDA consultation.
How does Ascletis approach drug development?
Ascletis employs advanced technologies like Artificial Intelligence-Assisted Structure-Based Drug Discovery to optimize their drug development processes.
What is Ascletis’ mission?
Ascletis aims to develop innovative therapeutics, focusing on addressing unmet medical needs across various conditions, particularly in metabolic diseases.
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