布局新藥！安成子公司獲美兩項專利許可MoneyDJ新聞 2014-06-26 17:43:46 記者 蕭燕翔 報導布局新藥，安成藥(4180)宣布，子公司安成生技獲得AC-201候選藥物美國專利與商標局（USPTO）2項專利許可通知，2項專利許可包含治療高血脂的糖尿病及降尿酸與預防痛風的適用範圍。安成生技是安成藥獨資的子公司，專注發展現無適當醫藥可滿足需求(unmet medical needs)的創新藥，尤其是先天免疫力有關疾病藥物的發展，現有產品Pipeline包括3個候選藥物，分別用於治療二型糖尿病、視網膜病變、關節炎和免疫性皮膚疾病。此次取得專利的主角-AC-201，是市場首見 (First in class)可口服的小分子新藥。先前已證實能抑制caspase-1與介白素1β（IL-1β）的生產和活性，並能下調IL-1β受體表現。而IL-1β信號的抑制，已被證明可有效地治療多種疾病，包括關節炎、痛風以及糖尿病。而AC-201的有效成分自1990年中期在法國與部分歐洲國家如西班牙和義大利，已被批准用於治療其他慢性風濕性疾病。此次AC-201取得的兩項專利，包括作為單一療法或與其他降血脂藥物組合的使用與方法，及治療患有二型糖尿病血脂異常病患或高尿酸血症患者，成為安成生技AC-201開發計畫廣泛的知識產權組合為的一部分。安成藥總經理陳志光表示，目前第二型糖尿病患者的血脂異常，仍大多以HMG-CoA還原?抑製劑（statin類藥品）控制血脂，而Statin類藥品在美國的重要用藥安全資訊說明中，提及包括有關對血糖的影響，包括應考慮增加糖化血色素(HbA1c)和空腹血糖上升的風險。此次AC-201獲得其一的專利，有助於用以發展治療同時患有血脂異常及第二型糖尿病的治療風險，先前二期臨床試驗已證明能有效降低二型糖尿病患者的糖化血色素(HbA1c)，安成生技已於去年(2013)在芝加哥美國糖尿病協會第73屆科學節公開259位受試者的跨國臨床二期研究成果。陳志光說，另一專利則增強保護其使用AC-201對高尿酸血症和痛風的治療方法。目前正規劃AC-201痛風治療的二期臨床試驗計劃，並預計於2014年第三季開始進行此試驗。安成生物科技股份有限公司擁有兩項AC-201的美國IND，一項為用於控制二型糖尿病患者血糖，另一項為治療痛風。AC-201在其在治療其他慢性疾病具良好的安全記錄，安成生技3項AC-201二期臨床試驗，治療時期最長達6個月，結果亦顯示具良好安全性。
A Dose-Ranging Study of Diacerein in Patients with Type 2 Diabetes The cytokine interleukin (IL)-1Beta, a regulator of inflammatory response, is implicated in the progression of type 2 diabetes mellitus (T2DM) through both insulin resistance and beta-cell function mechanisms. We assessed the safety and efficacy of diacerein, an orally available small molecule that modulates IL-1Beta signaling, in patients with T2DM uncontrolled on a stable regimen of 1 to 3 oral antidiabetic medications (OADs). In Study AC-201-DM-001, a randomized, double-blind, placebo-controlled, dose-ranging, 24-week Phase 2 study, 259 patients were randomized 1:1:1:1 to receive twice daily (BID) 25 mg, 50 mg, or 75 mg diacerein, or placebo. At baseline, patients with mean (SD) glycosylated hemoglobin (A1C) of 8.4 (0.7) % and fasting plasma glucose of 172 (43) mg/dL were enrolled and treated at 21 sites in the US (N=150) and Taiwan (N=109). In the Full Analysis Set (N=249), diacerein showed placebo-corrected least squares mean (SE) A1C reductions of 0.20 (0.17) %, 0.29 (0.18) %, and 0.35 (0.18) %* (*p<0.05) after 24 weeks of treatment in the 25 mg, 50 mg, and 75 mg groups, respectively. In the per-protocol (PP) population (N=184), the placebo-corrected A1C reduction was 0.37 (0.19) %, 0.42 (0.18) %*, and 0.49 (0.19) %*, for 25 mg, 50 mg, and 75 mg groups, respectively. Further, the US cohort had placebo-corrected A1C reductions in the PP population (N=104) of 0.61 (0.27) %*, 0.72 (0.25) %*, and 0.93 (0.26) %*, for 25 mg, 50 mg, and 75 mg groups, respectively. Differences in patient profiles such as background therapy (54% in Taiwan vs. 9% in US on 3 OADs) are possible reasons for the differences in efficacy results. The most frequent adverse event with diacerein was diarrhea (9%, 19%, 16%, and 32% in placebo, 25 mg, 50 mg, and 75 mg groups, respectively), which was mostly mild. Diacerein showed good dose response and was well tolerated up to 75 mg BID, demonstrating potential as a treatment for T2DM with a unique mode of action targeting the inflammation pathway associated with both impaired beta-cell function and insulin resistance. (by CARL O. BROWN, WEISHU LU, EMILY LIN, CALVIN CHEN)
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