Aligos 停止進一步開發 STOPS™ 候選藥物 ALG-010133

StephenW

Aligos 停止進一步開發 STOPS™ 候選藥物 ALG-010133
預計有效劑量（400 mg）的 1 期數據表明對乙型肝炎病毒的活性不足以證明進一步開發的合理性

美國東部時間 2022 年 1 月 6 日 08:00 |資料來源： Aligos Therapeutics

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加利福尼亞州南舊金山，2022 年 1 月 6 日 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS) 是一家臨床階段的生物製藥公司，專注於開發新的療法來解決病毒和肝臟疾病未滿足的醫療需求，今天宣布，它已停止進一步開發其 STOPS ™候選藥物 ALG-010133，該藥物正在開發中以治療慢性乙型肝炎（ CHB ）。該決定基於 1 期研究 ALG-010133-101 的新數據，該數據表明，在預計的有效劑量（400 mg，估計實現 HBsAg 抑制的肝臟暴露 > 3 x EC90）下，沒有有意義的 HBsAg 降低。此外，計劃在後續隊列中評估的更高劑量水平（最大可行劑量為 600 mg）不太可能達到 Aligos 先前定義為推進該計劃所必需的 1 log10 IU/mL HBsAg 降低水平。在以任何劑量水平給藥的 CHB 受試者中未發現劑量限制性安全性發現。基於這些信息，Aligos 管理層與研究審查委員會 (SRC) 的成員審查了數據，並共同得出結論，這些數據不足以支持 ALG-010133 的進一步開發，應該停止給藥。

“我們對這項研究的抗病毒活性數據表明 ALG-010133 無法對 CHB 的功能性治愈做出有意義的貢獻感到失望，”Aligos 董事長兼首席執行官 Lawrence M. Blatt 博士說。 “乙型肝炎是一種非常具有挑戰性的病毒，可能需要涉及不同作用機制 (MOA) 的組合方案才能實現功能性治愈。 Aligos 的產品線很深，有多種額外的 MOA——ASO、siRNA、CAM I、CAM-2 和 PD-L1 抑製劑——其中許多已經過臨床驗證，並且可能具有同類最佳的特性。具有這些 MOA 的兩種候選藥物——ALG-000184（CAM-2）和 ALG-020572（ASO）——目前正在臨床中，第三個（ALG-125755，siRNA）預計將在 2022 年年中進入臨床。我們仍然相信 Aligos 的管道有可能提高 CHB 患者的功能治愈率。”

StephenW

Aligos Halting Further Development of STOPS™ Drug Candidate, ALG-010133
Phase 1 data at projected efficacious dose (400 mg) indicate insufficient activity against hepatitis B virus to justify further development

January 06, 2022 08:00 ET | Source: Aligos Therapeutics

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SOUTH SAN FRANCISCO, Calif., Jan. 06, 2022 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, today announced that it has halted further development of its STOPS™ drug candidate, ALG-010133, in development to address chronic hepatitis B (CHB). This decision is based on emerging data from the Phase 1 Study ALG-010133-101 that indicate that at the projected efficacious dose (400 mg, estimated to achieve liver exposures >3 x EC90 for HBsAg inhibition) there is no meaningful HBsAg reduction. Furthermore, higher doses levels (maximum feasible dose is 600 mg) that were planned to be evaluated in a subsequent cohort are very unlikely to reach the 1 log10 IU/mL HBsAg reduction level that Aligos had previously defined as necessary to advance the program. No dose-limiting safety findings have been identified in CHB subjects dosed at any dose level. Based on this information, Aligos management reviewed the data with members of the study’s Study Review Committee (SRC) and jointly concluded that these data were not sufficient to support further development of ALG-010133 and that dosing should be discontinued.

“We are disappointed that the antiviral activity data from this study indicate that ALG-010133 cannot meaningfully contribute to achieving functional cures in CHB,” said Lawrence M. Blatt, Ph.D., MBA, Chairman and CEO of Aligos. “Hepatitis B is a very challenging virus that will likely require combination regimens involving distinct mechanisms of action (MOAs) in order to achieve functional cure. Aligos’ pipeline is deep, with multiple additional MOAs – ASO, siRNA, CAM I, CAM-2 and PD-L1 inhibitors – many of which are clinically validated and have potentially best-in-class properties. Two drug candidates with these MOAs – ALG-000184 (CAM-2) and ALG-020572 (ASO) – are currently in the clinic and a third (ALG-125755, siRNA) is projected to be in the clinic mid-year 2022. We continue to be confident that Aligos’ pipeline has the potential to enhance functional cure rates in patients with CHB.”