安成藥業(4180) AC-201預防痛風發作新適應症通過US FDA和TFDA之 發言時間 101/12/2219:06:38發言人 陳志光 發言人職稱 總經理 發言人電話 02-2657-3350主旨 : AC-201預防痛風發作新適應症通過US FDA和TFDA之IND審核符合條款第39款事實發生日101/12/21說明1.事實發生日:101/12/212.公司名稱:安成生物科技股份有限公司3.與公司關係(請輸入本公司或聯屬公司):本公司百分百轉投資之子公司4.相互持股比例(若前項為本公司，請填不適用):100%5.發生緣由:安成藥業百分百持有之子公司-安成生技獨立研發之新藥AC-201，除原有第二型糖尿病適應症外，其預防痛風發作之新適應症亦已順利通過美國食品藥管理局(Food and Drug Administration, FDA)及台灣食品藥物管理局IND (Investigational NewDrug)審核，即將於2013年1月於台灣和美國直接進入Phase IIa人體臨床試驗。6.因應措施:不適用7.其他應敘明事項:無以上資料均由各公司依發言當時所屬市場別之規定申報後，由本系統對外公佈，資料如有虛偽不實，均由該公司負責.
TWi Pharmaceuticals Announces Positive Phase IIb Clinical Trial Results of AC-201 in Patients with Type 2 Diabetes. TAIPEI, Taiwan, Aug. 6, 2012 /PRNewswire-Asia/ -- TWi Pharmaceuticals, Inc., a specialty pharmaceutical company based in Taiwan, today announced its fully owned subsidiary, TWi Biotechnology, Inc. has completed a multinational phase II dose-ranging study of AC-201, an orally available IL-1 Beta modulator, in 259 patients with type II diabetes uncontrolled on up to three oral medications. In the intent-to-treat population, AC-201 showed placebo-corrected reductions in HbA1c of 0.20%, 0.29%, and 0.35%*(* indicates statistical significance with p<0.05) after 24 weeks of treatment in the three tested dose groups of 25 mg, 50 mg, and 75mg twice daily (b.i.d), respectively. In the per-protocol population, the placebo-corrected reduction in HbA1c was 0.37%, 0.42%*, and 0.49%*, for 25 mg, 50 mg, and 75 mg b.i.d dose groups, respectively. AC-201 showed good dose response and was well tolerated up to 75 mg b.i.d. The most frequent side effect was diarrhea that was mostly mild. The clinical trial was conducted in the United States, where 150 patients were enrolled in 13 sites, and Taiwan, where 109 patients were enrolled in 8 sites. Further analysis revealed that AC-201 in the US cohort demonstrated placebo-corrected HbA1c reductions in the per-protocol population of 0.61%*, 0.72%*, and 0.93%*, for 25 mg, 50 mg, and 75mg b.i.d dose groups, respectively. The differences in patient profiles such as BMI (mean baseline of 27 kg/m square in Taiwan vs. 32kg/m square in the US), background anti-diabetic therapy (54% in Taiwan vs. 9% in the US of patients taking 3 oral anti-diabetic drugs), and medical practices between the two cohorts are possible reasons for the differences in efficacy results. "We are pleased to see AC-201 once again demonstrated a good potential to be a treatment for patients with type II diabetes; the data from patients in the US are especially encouraging," said Calvin Chih-Kuang Chen , Ph.D., acting president of TWi Pharmaceuticals. Referencing AC-201's unique mode of action that targets the inflammation pathway associated with both impaired beta-cell function and insulin resistance, Dr. Dee Pei, Professor of Medicine, Fu Jen Catholic University and Chief of Internal Medicine, Cardinal Tien Hospital , Taipei, Taiwan, said: "I am mostly impressed by AC-201's ability to reduce HbA1c levels in those very difficult to treat patients. AC-201 could be a very useful tool when combinations of drugs are required to achieve successful control of blood sugar in certain type II diabetic patients."
About AC-201 AC-201 is the only orally available small molecule in development which modulates the intracellular synthesis of the cytokine IL-1Beta. Inhibition of IL-1Beta signaling has been demonstrated to be effective in treating a variety of inflammatory diseases including arthritis, diabetic nephropathy (DN) and diabetic mellitus (DM).
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