HANGZHOU and SHAOXING, China, Oct. 11, 2023 /PRNewswire/ — Ascletis Pharma Inc. (HKEX:1672, "Ascletis") today announces the poster presentation of Phase II study topline results of ASC40, a first-in-class fatty acid synthase (FASN) inhibitor for treatment of acne, at the European Academy of Dermatology and Venereology (EADV) Congress 2023 in Berlin, Germany. The summary of the poster is shown as below:
Title: ASC40, an oral once-daily fatty acid synthase (FASN) inhibitor, in patients with acne vulgaris: topline results from a Phase II randomized, double-blind, placebo-controlled, multicenter trial
Presenter: Jinzi J. Wu, Ph.D.
Principal Investigator: Professor Leihong Xiang, Huashan Hospital, Fudan University
Poster ID: P0053
Part of Session: Acne and related disorders, hidradenitis suppurativa
Study Design:
This Phase II trial (ClinicalTrials.gov: NCT05104125) was a randomized, double-blind, placebo-controlled, multicenter study. 180 patients with moderate to severe acne vulgaris were randomized into three active treatment arms and one placebo control arm at the ratio of 1:1:1:1 to receive ASC40 (25 mg, 50 mg or 75 mg tablet) or matching placebo tablet orally, once daily for 12-week treatment and 2-week follow-up. Efficacy and safety of 12-week treatment of ASC40 or placebo were assessed.
Results:
Table 1 summarized the topline data of primary and key secondary efficacy endpoints at Week 12 versus baseline. Overall, all three doses of ASC40 demonstrated good efficacy compared to placebo. The efficacy of ASC40 seemed maxed out at 50 mg dose.
Table 1. Primary and key secondary efficacy endpoints of 25 mg, 50 mg and 75 mg ASC40, oral, once daily tablet for 12 weeks vs placebo (n=179)
Endpoint
25 mg ASC40, oral, once
daily, 12 weeks (n=45)
50 mg ASC40, oral, once
daily, 12 weeks (n=44)
75 mg ASC40, oral, once
daily, 12 weeks (n=45)
Placebo, oral, once
daily, 12 weeks (n=45)
% change from baseline in total lesion count at
week 12 (primary endpoint) §
-53.2
-61.3
-53.1
-34.2
P value vs placebo
0.005
0.008
0.008
NA
Absolute change from baseline in total lesion count
at week 12 (key secondary endpoint) §
-56.0
-60.5
-46.0
-37.0
P value vs placebo
0.024
0.030
0.083
NA
% change from baseline in inflammatory lesion
count at week 12 (key secondary endpoint) §
-54.4
-65.0
-60.0
-31.4
P value vs placebo
0.006
0.003
0.029
NA
Absolute change from baseline in inflammatory
lesion count at week 12 (key secondary endpoint) §
-25.0
-26.0
-22.0
-13.0
P value vs placebo
0.007
0.003
0.032
NA
Note: § Data are medians.
Conclusion:
Topline results of this study showed that oral ASC40, once daily, 12-week treatment was safe and well tolerated. ASC40 improved significantly in total lesion, inflammatory lesion, and IGA (Investigator’s Global Assessment) treatment success. Based on efficacy and safety assessment of this Phase II study, the Phase III clinical trial is warranted and will be initiated soon.
"It’s a great honor to present our Phase II clinical trial results of ASC40 for acne treatment at the EADV Congress. Acne is the eighth most prevalent disease in the world and affects more than 640 million people globally.[1] The FASN inhibitor ASC40 is a first-in-class drug candidate with novel mechanism, demonstrating significant efficacy and good safety in the Phase II clinical trial. The Phase III clinical trial of ASC40 for acne will be initiated soon and we expect to provide a new option for acne patients in the future." said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis.
[1] Tan J K, Bhate K. A global perspective on the epidemiology of acne [J]. Br J Dermatol 2015, 172 Suppl 1(3-12). DOI: 10.1111/bjd.13462.
About EADV
The European Academy of Dermatology and Venereology (EADV) has over 8,500 members and an active community of more than 14,000 professionals around the world. The EADV Congress is the annual international congress for the latest scientific advances and research in dermatology & venereology, bringing together healthcare professionals, organisations and industry from around the world to maximise impact. This year’s event will be held in Berlin, Germany from October 11 to 14.
About Ascletis
Ascletis is an innovative R&D driven biotech listed on the Hong Kong Stock Exchange (1672.HK), covering the entire value chain from discovery and development to manufacturing and commercialization. Led by a management team with deep expertise and a proven track record, Ascletis focuses on three therapeutic areas with unmet medical needs from a global perspective: viral diseases, non-alcoholic steatohepatitis (NASH) and oncology. Through excellent execution, Ascletis rapidly advances its drug pipeline with an aim of leading in global competition. To date, Ascletis has multiple drug candidates in its R&D pipeline. The most advanced drug candidates include ASC22 (CHB functional cure), ASC40 (acne), ASC40 (recurrent glioblastoma), ASC40 (NASH), ASC41 (NASH) and ASC61 (advanced solid tumors).
ASC40 is licensed from Sagimet Biosciences Inc. for the exclusive rights in the Greater China.
For more information, please visit www.ascletis.com.
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