ALG-010133

Aligos Therapeutics is laying off workers and focusing its resources on drug candidates for NASH and Covid-19, a move that comes after clinical trial setbacks in the past year to two hepatitis B programs. The layoffs announced after market close Wednesday will trim Aligos’s staff by about 10%. At the end of the third quarter of 2022, South San Francisco-based Aligos reported having 89 full-time employees, including 72 who work in R&D. But the company said attrition and targeted hiring means the overall headcount reduction is about 25% since last January. That’s when the company stopped development of drug candidate ALG-010133 in chronic hepatitis B infection after Phase 1 results failed to show enough activity at the projected efficacious dose. Two months later, the biotech stopped work on ALG-020572 after signs of liver toxicity were observed in a Phase 1 test. Both failed hepatitis B drugs were antisense oligonucleotides. The Aligos programs for non-alcoholic steatohepatitis (NASH) and Covid-19 are small molecules. The NASH drug candidate, ALG-055009, is designed to bind to and activate thyroid hormone receptor beta (THR-β), an approach intended to reduce liver fat and lead to improvement in the tissues and cells of the organ. Other biotechs are developing NASH drugs that hit this target. Madrigal Pharmaceuticals reported positive Phase 3 data in December that it said pave the way for a planned FDA regulatory submission for its drug candidate this year. Viking Therapeutics said Wednesday that a Phase 2b study for its NASH drug candidate has completed enrollment and preliminary data are expected in the second quarter of this year. Aligos said its NASH drug will complete Phase 1 testing in the first half of this year; a filing to commence Phase 2 testing could be submitted by the end of the year. Aligos’s antiviral research is focused on ALG-097558, a protease inhibitor with potential applications addressing multiple coronaviruses including SAS-CoV-2. The company says one advantage of its antiviral candidate is that it does not need dosing with ritonavir, a booster. Pfizer’s Covid-19 antiviral, Paxlovid, is indicated for use with ritonavir, which means a patient needs to take additional pills. Pardes Biosciences is also developing a Covid-19 antiviral that would not require dosing with ritonavir. The Pardes antiviral candidate, PBI-0451, is expected to post Phase 2 data in the first quarter of this year. Aligos said it expects to complete a Phase 1 test in healthy volunteers in the second half of this year, which would enable it to start a Phase 2 study by the end of the year. Despite its previous failures in hepatitis B, Aligos is not abandoning the indication. ALG-000184, a small molecule, has reached a Phase 1b dose-ranging study in chronic hepatitis B patients. Aligos said it expects to present data from cohorts in the study at scientific conferences throughout the year. A small-interfering RNA drug candidate called ALG-125755 is also in development for hepatitis B. Aligos said that it will continue to develop this candidate in a Phase 1 single-ascending dose study and present data at scientific conferences this year. The pipeline reprioritization leaves intact a Merck collaboration developing oligonucleotide drugs for NASH. The alliance spans two programs, both of which are in the discovery stage. “With such a diverse clinical portfolio, including four drug candidates in or near the clinic, as well as maintaining a strong discovery engine, where we continue to support multiple research collaborations, we determined that Aligos would be best positioned to achieve its business objectives by taking action now to streamline operations, reprioritize its portfolio, and implement certain cost-saving measures, including a reduction in force,” Aligos CEO Lawrence Blatt said in a prepared statement.

来源：企业公告   整理：wangxinglai2004康弘药业撤回临床申请一、公告主要内容根据企业申报策略调整，成都康弘药业集团股份有限公司子公司成都弘基生物科技有限公司（以下简称“弘基 生物”）向国家药品监督管理局药品审评中心提交《关于撤回 KH631 眼用注射液注册申请的申请》。近日，弘基生物收到国家药品监督管理局药品审评中心关于同意撤回注册申请的《药品注册申请终止通知 书》。二、药品基本信息药品名称：KH631眼用注射液 剂型：注射液 适应症：新生血管性（湿性）年龄相关性黄斑变性（nAMD） 受理号：CXSL2200201、CXSL2200202、CXSL2200203、CXSL2200204、 CXSL2200205、CXSL2200206 审批意见：根据申请人提交的撤回申请，同意本品注册申请的撤 回，终止注册程序。KH631眼用注射液是通过腺相关病毒(AAV)递送目标基因用于治疗新生血管性（湿性）年龄相关性黄斑变性（nAMD）的、具有自主知识产权的 1 类生物新药。该产品以具有自主知识产权的腺相关病毒(AAV)递送系统为基础，在组织特异性、免疫原性、表达可控性和感染效率上具有特色， 并在临床前疾病模型中显示出持续疗效。默沙东宣布其Keytruda联用Lenvima的Ⅲ期临床失败该项名为LEAP-002的临床试验，研究的优效性假设为帕博利珠单抗+乐伐替尼治疗HCC(即肝细胞癌)患者的疗效要优于乐伐替尼单药。不过结果却事与愿违，与单独接受乐伐替尼治疗相比，接受帕博利珠单抗+乐伐替尼治疗患者的总生存期等临床数据虽有改善趋势，但结果不具有统计学显著改善意义。近期研发失败汇总6月16日，罗氏和班纳老年痴呆症研究所联合宣布，crenezumab(克雷内治单抗)在阿尔茨海默症预防倡议(API)项目中的II期临床未达到主要研究终点。6月，Rigel Pharmaceuticals宣布，Syk抑制剂fostamatinib(福他替尼)用于治疗温抗体型自身免疫性溶血性贫血的全球、多中心、随机、双盲、安慰剂对照III期FORWARD试验未达到主要终点。6月份，沃森生物宣布控股子公司上海泽润考虑到国内手足口病流行趋势的演变情况，决定终止重组EV71疫苗研发的消息；5月11日，罗氏公布的PD-L1+TIGIT联合一线治疗非小细胞肺癌三期临床SKYSCRAPER-01的中期数据研究结果显示，该研究没有达到其无进展生存期的共同主要终点。5月，Idorsia Pharmaceuticals旗下ACT-539313疗法在II期试验中未能达到主要终点，该公司随后表示将不再继续研究使用ACT-539313治疗暴食症。2月，赛诺菲与再生元对抗炎药Dupixent治疗慢性自发性荨麻疹(CSU)3期项目进行了更新。根据预先指定的中期分析，评估Dupixent治疗奥玛利珠单抗(omalizumab)难治性CSU患者的一项3期试验(CUPID STUDY B)，因被判定无效而将停止。1月份，Aligos Therapeutics消息，公司研发的S-抗原转运抑制寡核苷酸聚合物 (STOPS™)ALG-010133，因其未能实现理想的降低乙肝表面抗原(HBsAg)水平停止了开发工作。你的每一次“在看”，我都看得见！