Trimetazidine Hydrochloride

A biotech incubated by RA Capital has secured a $57.5 million Series B to begin a mid-stage trial for its cardio drug this quarter and get to a readout in late 2026. Imbria Pharmaceuticals has now raised a total of about $150 million in equity financing, CEO Alvin Shih exclusively told Endpoints News . The Boston startup, which has eight employees, has not previously disclosed its fundraising. Imbria’s financial backers include RA, SV Health Investors, Deep Track Capital, AN Ventures and Catalio Capital Management. The money is expected to help the company prove whether its oral medicine, code-named ninerafaxstat , can treat patients with non-obstructive hypertrophic cardiomyopathy, or HCM, in a Phase 2b study. The biotech now has a runway into the second half of 2027, according to Shih, who joined Imbria as a board member last year and is now CEO. Anne Prener, a former partner at SV Health, was president and CEO of Imbria from 2020 until September, according to her LinkedIn. Shih has spent the past few quarters trying to secure funding in a challenging market. “It has not been easy. The environment is very difficult, but I would say raising money for my previous company — Catamaran [Bio] in the cell therapy space — was impossible,” he said, referring to the CAR-NK cell therapy biotech that closed last year . “This was just difficult.” Imbria will also benefit from the expertise of Cytokinetics, which chipped into the startup’s Series B. “Their involvement validates our approach,” Shih said. The California drug developer’s aficamten is in late-stage development in similar cardio fields as Imbria’s ninerafaxstat; however, Cytokinetics doesn’t have any operational control over ninerafaxstat, Shih confirmed. Eventually, and maybe with the help of a partner, Imbria plans to continue testing the twice-daily drug in other cardio indications like heart failure with preserved ejection fraction, or HFpEF. The drug has already gone through a Phase 2a in HFpEF. Imbria said the drug met the trial’s primary endpoint in a presentation at last month’s annual American College of Cardiology conference. “It’s become an epidemic,” Shih said. “HFpEF is the fastest-growing segment of heart failure, and it’s clear that even with GLP-1s, you haven’t totally fixed the problem, and so patients are going to need additional therapeutics.” Ninerafaxstat is a partial fatty acid oxidation (pFOX) inhibitor. Shih said the goal is to make the heart less reliant on fatty acids, which is common in heart failure patients, and more reliant on glucose, which could boost metabolism and make for a more well-oiled mitochondrial engine. With better energy generation, cardiac function should improve. Shih said the experimental oral drug has demonstrated improvement in “cardiac energetics,” key functional outcomes and quality of life outcomes, including on the Kansas City Cardiomyopathy Questionnaire, a self-administered survey for heart failure patients. “That is what is going to be the approvable endpoint in both HCM and HFpEF,” Shih said. RA Capital got the idea from a decades-old drug called trimetazidine , which has been commercialized in Europe to treat angina but is not approved by the FDA. “It’s known to have some activity in the cardiac mitochondria, but what they wanted to do was to optimize the molecule and they ended up creating a new molecule that results in trimetazidine as one of its metabolites, but also has other active metabolites,” Shih said. It’s “sort of getting more bang for the buck on the mechanism, which is in the mitochondria.”

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。近日，立方制药申报的4类仿制药帕利哌酮缓释片（6mg、3mg）获批生产并视同过评。这是一种新型抗精神病药物，为渗透泵制剂，该剂型可缓慢释放药效成分，持续稳定血药浓度，具有良好的安全性。适用于成人及12-17岁青少年精神分裂症的治疗。截图来源：摩熵医药-中国药品审评数据库帕利哌酮缓释片的原研产家为美国强生（Johnson & Johnson）公司旗下杨森制药，该药2006年以商品名INVEGA在美国上市。在中国，原研产品帕利哌酮缓释片于2008年以商品名芮达获批上市，用于治疗成人精神分裂症。2017年，该药再次获NMPA批准，用于青少年（12~17岁，体重≥29kg）精神分裂症患者的治疗。近年来，帕利哌酮缓释片已经成为抑郁症首发患者的一线用药选择。原研产品芮达已进入2018年中国国家基本药物目录，并在2019年进入国家医保目录。除原研外，2020年6月，江苏豪森首家过评；2022年3月，太阳制药/康哲生物已5.2类化药获得批准；2022年6月，石药集团欧意药业仿制药获批上市；2024年7月，泛谷药业/德芮可制药仿制药批准上市；立方制药为第5家帕利哌酮缓释片仿制药获批上市企业。据摩熵医药-全国医院全终端销售数据库显示，2023年抗精神病药物销售额为61亿元，2024年Q1-3销售额47.49亿元。帕利哌酮缓释片2023年度销售额为6.38亿元，2024年前三季度为5.5亿元。从2024年前三季度销售额竞争格局来看，首仿豪森药业占比为56%，杨森制药占比为40%，其他厂家销售额占比还较小。截图来源：摩熵医药-销售数据库（全国医院端）小结立方制药依托渗透泵控释技术，建立丰富渗透泵制剂产品管线基于渗透泵控释技术的平台优势，目前已上市的产品包括非洛地平缓释片（Ⅱ）、甲磺酸多沙唑嗪缓释片、硝苯地平控释片、盐酸曲美他嗪缓释片等，此次帕利哌酮缓释片上市进一步丰富了精神类领域产品布局。END本文为原创文章，转载请留言获取授权近期热门资源获取CGT产业现状与未来趋势蓝皮书-202406中药行业现状与未来趋势白皮书-2024072023年医药企业综合实力排行榜-202408跨越国界，引领创新：中国药企出海的布局实践-202408专利即将到期五大重磅小分子药品，国内仿制药“战况”几何?-202409中国放射性药物市场现状分析报告-202410合成生物产业发展前景及中国合成生物产业链上中下游企业分析-202410中国合成生物学创投市场分析报告-202410中国糖尿病临床诊疗与药物多渠道市场数据分析-202411基于剂型改良的复杂注射剂分析--微球篇-2024112024医美注射材料市场发展分析报告-20241213国家药品集采跟踪报告-前9批次集采回顾与展望-202411近期更多摩熵咨询热门报告，识别下方二维码领取联系我们，体验摩熵医药更多专业服务会议合作园区服务数据库咨询定制服务媒体合作👆👆👆点击上方图片，即可开启摩熵化学数据查询点击阅读原文，申请摩熵医药企业版免费试用！