Ascletis Announces Poster Presentation of Phase II Study Final Results of FASN Inhibitor ASC40 for Treatment of Acne at 2024 AAD Annual Meeting
Ascletis Announces Poster Presentation of Phase II Study Final Results of FASN Inhibitor ASC40 for Treatment of Acne at 2024 AAD Annual Meeting
HANGZHOU and SHAOXING, China, March 11, 2024 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") today announces the poster presentation of Phase II study final results of ASC40, a first-in-class fatty acid synthase (FASN) inhibitor for treatment of acne, at the 2024 American Academy of Dermatology (AAD) Annual Meeting in San Diego, the United States.
中國杭州和紹興，2024年3月11日 /PRNewswire/ — Ascletis Pharma Inc.（香港交易所：1672，“Ascletis”）今天在美國聖地亞哥舉行的2024年美國皮膚科學會（AAD）年會上公佈了用於治療痤瘡的同類首創脂肪酸合酶（FASN）抑制劑 ASC40 的二期研究最終結果的海報展示。
The summary of the poster is shown as below:
海報摘要如下所示：
Title:
標題：
First FASN inhibitor ASC40 to treat acne vulgaris patients: final results from a Phase 2 trial
首款用於治療尋常痤瘡患者的 FASN 抑制劑 ASC40：2 期試驗的最終結果
Method:
方法：
This phase 2 trial (NCT05104125) was a randomized, double-blind, placebo-controlled, multicenter study. 180 patients were 1:1:1:1 assigned to the ASC40 25\50\75 mg or placebo QD for 12-week treatment and 2-week follow-up. Efficacy and safety of ASC40 vs placebo were assessed.
該2期試驗（NCT05104125）是一項隨機、雙盲、安慰劑對照、多中心研究。180名患者以 1:1:1:1 的比例分配 ASC40 25\ 50\ 75 mg 或安慰劑 QD 進行爲期 12 周的治療和 2 周的隨訪。評估了 ASC40 與安慰劑的療效和安全性。
Background:
背景：
ASC40 (denifanstat) is a potent and selective small molecule inhibitor of fatty acid synthase (FASN). Mechanisms of action of ASC40 for acne treatment are novel: (1) direct inhibition of facial sebum production through inhibition of de novo lipogenesis (DNL) in sebocytes; and (2) inhibition of inflammation through decreasing cytokine secretion. Previous clinical studies showed that ASC40 treatment for 10 days reduced significantly facial sebum palmitic acid levels. Here we report the efficacy and safety results from a phase 2 study of ASC40 in patients with moderate to severe acne vulgaris after 12-week treatment.
ASC40（denifanstat）是一種有效的選擇性小分子脂肪酸合酶（FASN）抑制劑。ASC40 治療痤瘡的作用機制是新穎的：（1）通過抑制面部皮脂直接抑制面部皮脂的產生 從頭再來 皮脂細胞中的脂肪生成（DNL）；以及（2）通過減少細胞因子分泌來抑制炎症。先前的臨床研究表明，ASC40 治療 10 天可顯著降低面部皮脂棕櫚酸水平。在這裏，我們報告了 ASC40 對中度至重度尋常型痤瘡患者的2期研究的療效和安全性結果，該研究經過12周的治療。
Results:
結果：
At week 2, 4, 8 and 12, percentage and absolute change from baseline in total lesion, inflammatory and non-inflammatory lesion counts as well as treatment success and Investigator's Global Assessment (IGA) reduction ≥ 2 were assessed. At all doses, above efficacy measures generally improved from week 2 to week 12. 50 mg QD demonstrated the best efficacy: placebo-adjusted proportion of patients with treatment success and IGA reduction ≥ 2 were 14.3% and 16.2%, respectively. Placebo-adjusted median percentage (absolute) change from baseline in total lesion and inflammatory counts were -27.1% (-23.5) and -33.5% (-13), respectively (p = 0.008 (0.030) and 0.003 (0.003)).
在第2、4、8和12周，評估了總病變、炎症和非炎性病變數量以及治療成功率和研究者全球評估（IGA）減少量≥2的百分比和絕對變化與基線。在所有劑量下，上述療效指標在第2周至第12周普遍有所改善。50 mg QD顯示出最佳療效：經安慰劑調整的治療成功和IGA減少≥2的患者比例分別爲14.3％和16.2％。安慰劑調整後的總病變和炎症計數與基線相比的中位百分比（絕對）變化分別爲-27.1％（-23.5）和-33.5％（-13）（p = 0.008 (0.030) 和 0.003 (0.003))。
Safety:
安全：
The incidence rates of study drug related AEs were comparable among 25 mg (grade 1 = 28.9%; grade 2 = 20.0%), 50mg (grade 1 = 36.4%; grade 2 = 11.4%), 75 mg (grade 1 = 44.4%; grade 2 = 17.8%) ASC40 and placebo (grade 1 = 35.6%; grade 2 = 13.3%). The most common study drug related AE was dry eyes whose incidence rates were similar among 25 mg (grade 1 =17.8%; grade 2 = 6.6%), 50 mg (grade 1 = 22.7%; grade 2 = 2.3%), 75 mg (grade 1 = 15.5%; grade 2 =11.1%) ASC40 and placebo (grade 1 = 28.9%; grade 2 = 6.6%). There were no clinically significant findings in clinical laboratory, vital signs and electrocardiography. There were no ASC40 related grade 3 or 4 AEs and no ASC40 related serious AEs (SAEs).
25 mg（1 級 = 28.9%；2 級 = 20.0%）、50 mg（1 級 = 36.4%；2 級 = 11.4%）、75 mg（1 級 = 44.4%；2 級 = 17.8%）ASC40 和安慰劑（1 級 = 35.6%；2 級 = 13.3%）的研究藥物相關不良反應的發病率相當。研究中最常見的藥物相關不良反應是乾眼症，其發病率在25 mg（1級= 17.8％；2級= 6.6％）、50 mg（1級 = 22.7％；2級 = 2.3％）、75 mg（1級 = 15.5％；2級 = 11.1％）ASC40 和安慰劑（1級 = 28.9％；2級 = 6.6％）中發病率相似。臨床實驗室、生命體徵和心電圖沒有臨床顯著的發現。沒有 ASC40 相關的 3 級或 4 級 AE，也沒有 ASC40 相關的嚴重不良事件 (SAE)。
Conclusion:
結論：
Based on efficacy and safety data from this phase 2 trial, a phase 3 clinical trial of 50 mg QD ASC40 with 12-week treatment has been initiated.
根據這項2期試驗的療效和安全性數據，一項爲期12周的治療的50 mg QD ASC40 的3期臨床試驗已經啓動。
"It's a great honor to present our Phase II clinical trial results of ASC40 for acne treatment at the AAD Annual Meeting. 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. Currently, the enrollment of Phase III clinical trial of ASC40 for acne is accelerating. We expect to bring more benefits for acne patients in the future." said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis.
“很榮幸能夠在 AAD 年會上介紹我們針對痤瘡治療的 ASC40 的二期臨床試驗結果。FASN 抑制劑 ASC40 是同類首款具有新機制的候選藥物，在 II 期臨床試驗中顯示出顯著的療效和良好的安全性。目前，針對痤瘡的 ASC40 三期臨床試驗的註冊正在加速。我們預計未來將爲痤瘡患者帶來更多益處。” Ascletis創始人、董事長兼首席執行官吳金子博士說。
Ascletis holds the rights to develop, manufacture and commercialize ASC40 in Greater China under an exclusive license from Sagimet Biosciences Inc.
根據Sagimet Biosciences Inc.的獨家許可，Ascletis擁有在大中華區開發、製造和商業化 ASC40 的權利。
About AAD
關於 AAD
Founded in 1938, the annual meeting of the American Academy of Dermatology (AAD) is the largest, most influential, and most representative dermatological society in the United States. The 2024 AAD Annual Meeting is held at the San Diego Convention Center in San Diego, the United States, from March 8 to March 12, 2024.
美國皮膚科學會（AAD）年會成立於1938年，是美國最大、最具影響力和最具代表性的皮膚病學會。2024 年 AAD 年會將於 2024 年 3 月 8 日至 3 月 12 日在美國聖地亞哥的聖地亞哥會議中心舉行。
About Ascletis
關於 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).
Ascletis是一家以研發爲導向的創新生物技術公司，在香港證券交易所（1672.HK）上市，涵蓋從發現和開發到製造和商業化的整個價值鏈。Ascletis由一支擁有深厚專業知識和良好記錄的管理團隊領導，專注於從全球角度看醫療需求未得到滿足的三個治療領域：病毒性疾病、非酒精性脂肪肝炎（NASH）和腫瘤學。通過出色的執行力，Ascletis迅速推進其藥物管線，目標是在全球競爭中處於領先地位。迄今爲止，Ascletis的研發管道中有多種候選藥物。最先進的候選藥物包括 ASC22（CHB 功能治癒）、ASC40（痤瘡）、ASC40（複發性膠質母細胞瘤）、ASC40（NASH）、ASC41（NASH）和 ASC61（晚期實體瘤）。
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