Lassen Therapeutics LLC

Innovent plans to release detailed results from the study at future medical conferences or in journals. Innovent Biologics is hoping that a phase 3 win for its thyroid eye disease (TED) treatment will provide a first shot at the Chinese equivalent of a market that has already been conquered by Amgen’s Tepezza in the U.S. Like Tepezza, Innovent’s candidate IBI311 targets the insulin-like growth factor 1 receptor (IGF-1R). The candidate hit the primary endpoint of the phase 3 Restore-1 trial by showing a greater reduction in eyeball protrusion—known as proptosis—than placebo. The percentage of subjects with a reduction in proptosis of 2 mm or more in one eye without the equivalent increase in proptosis in the other eye was 85.8% among the IBI311 group, compared with just 3.8% among those who received placebo. The candidate also showed “significant” improvement on key secondary endpoints for the trial, including overall response rate, percentage of subjects with a clinical activity score of 0 or 1, and mean change in proptosis from baseline, Innovent said in a Feb. 20 release. No serious adverse events occurred, added the biotech, which plans to release detailed results from the study at future medical conferences or in journals. Lei Qian, vice president of clinical development at Innovent, said the company plans to submit a new drug application to Chinese regulators “as soon as possible” based on the results. TED occurs in 16 out of every 100,000 women and 2.9 in every 100,000 men, according to Innovent. The condition is clearly a tempting target, with Horizon Pharma’s Tepezza quickly securing blockbuster sales. Horizon noticed a drop off in uptake in the drug’s third year on the market, with Amgen making this a top priority when it acquired the biotech in October 2023. Still, as the only approved treatment for TED in the U.S., Tepezza garnered sales of $1.66 billion in its first full year on the market and $1.97 billion in 2022 before stalling out. Amgen also sees an international opportunity for Tepezza. The drug is under review in Japan and the company will file this year for approval in Europe. A subcutaneous version of the treatment is also in development. "There are no targeted drugs approved in the field of TED in China so far, while the treatment costs of overseas targeted drugs are beyond many patients' reach,” Qian explained in Innovent’s release this morning. The clinical success of IBI311’s comes a month after mazdutide, a GLP-1/glucagon receptor agonist that Innovent licensed from Eli Lilly, demonstrated weight loss abilities in a phase 3 trial. Qian aligned these recent wins with the Chinese approval of its hypercholesterolemia injection Sintbilo in August 2023 as proof of the strength of Innovent’s late-stage strategy. “With the approval of Sintbilo, the NDA acceptance of mazdutide and the endpoints met in phase 3 study of IBI311, Innovent is strategically establishing its innovative commercial and late-stage portfolio in the fields of cardiovascular and metabolic diseases, endocrinology and ophthalmology,” Qian added. Innovent isn’t the only biotech looking to stake out a piece of TED territory. Last month, Kriya Therapeutics announced plans to get a gene therapy into the clinic for the condition next year, while Lassen Therapeutics has already dosed the first patient in a phase 1 trial of an interleukin-11 receptor targeted at TED.

2024年1月29日，Madrigal在等待NASH新药Resmetirom批准之际，宣布了新的人事变动。Mark Barrett任首席商务官，Clint Wallace任首席人力资源官，Tina Ventura任首席投资者关系官。Mark Barrett拥有超25年的生物制药领导和行业经验，在商务合作、收并购、建立跨治疗领域的商业投资组合有着丰富且成功的从业经验。在加入Madrigal之前，他曾担任Lassen Therapeutics的联合创始人、董事兼首席执行官；曾是Frazier Healthcare Partners的常驻企业家；曾在强生和赛诺菲担任战略和业务发展的领导职务。Barrett先生拥有加州大学伯克利分校的工商管理硕士学位和杜克大学的生物学学士学位。在加入 Madrigal 之前，Clint Wallace 曾在 Kenvue 担任人力资源、全球职能和组织高级副总裁，负责组织设计和人才继任战略。在加入Kenvue 之前，他于 2016 年至 2022 年担任赛诺菲北美人力资源高级副总裁，担任赛诺菲全球人力资源领导团队成员。在加入赛诺菲之前，Wallace 先生曾在BASF Corporation、GE Healthcare 和 Pratt & Whitney 担任人力资源领导职务。Wallace 先生曾是美国空军的一名军官，在服役 21 年后于 2008 年 6 月退休。他拥有伦斯勒理工学院的工商管理硕士学位和康涅狄格州立大学的制造工程学士学位。Tina Ventura拥有近25年的全球医疗保健投资者关系和沟通经验。在加入Madrigal之前，她曾担任Horizon Therapeutics（被安进收购）的首席投资者关系官，领导该公司的投资者关系工作，建立和发展其投资者基础，并推动股东价值创造。在加入Horizon 之前，Ventura在雅培工作了16年，曾担任该司投资者关系部门副总裁。她被《机构投资者》评为头号IR专业人士。Ventura 拥有芝加哥洛约拉大学的工商管理硕士学位和Northwestern University的传播学学士学位。Madrigal的首席执行官Bill Sibold对三者的加入表示了欢迎，他认为，在Madrigal为resmetirom上市做准备之际，新的领导者们是为了公司的下一阶段做人才基础。封面图来源：123rf金凯生科“20cm”涨停，司美格鲁肽口服版带动减肥药概念拉升！全球CDMO巨头Lonza将关闭广州工厂，裁员300人。好消息是CDMO企业销售额纷纷增长！GLP-1RA类药物迈入口服时代！诺和忻®（司美格鲁肽片）在中国获批点击阅读原文，查看更多精彩内容

CONSHOHOCKEN, Pa., Jan. 29, 2024 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), today announced three new members of its leadership team: Mark Barrett joins Madrigal as Chief Business Officer, Clint Wallace joins as Chief Human Resources Officer and Tina Ventura joins as Chief Investor Relations Officer. “I am delighted to welcome Mark, Clint and Tina to the team,” said Bill Sibold, Chief Executive Officer of Madrigal. “As we prepare for a first-to-market launch of resmetirom in NASH with significant fibrosis, we are also building a foundation for enduring leadership. These new leaders are not only experts in their respective areas but have experience scaling teams and organizations. They will each play a pivotal role in Madrigal’s next phase of growth.” Mark Barrett brings more than 25 years of biopharmaceutical leadership and industry experience to Madrigal, with a track record of success completing a wide range of partnerships and acquisitions to build commercial portfolios and R&D pipelines across therapeutic areas. He was most recently co-founder, Director, and CEO of Lassen Therapeutics, a biotechnology company focused on discovery and development of novel antibody therapeutics in immunological diseases and cancer. Mr. Barrett has also served as Entrepreneur in Residence at Frazier Healthcare Partners, where he focused on starting and financing new biotech companies. Prior to Lassen, he held leadership positions in Strategy and Business Development at Johnson & Johnson and Sanofi. He holds an M.B.A from the University of California at Berkeley and a B.S. degree in Biology from Duke University. Clint Wallace joins Madrigal from Kenvue, where he served as Senior Vice President Human Resources, Global Functions and Organizations and was responsible for organizational design and talent succession strategy. Prior to Kenvue, he was the Senior Vice President Human Resources, North America, Sanofi, from 2016-2022, serving as a member of the Sanofi Global HR Leadership Team. Prior to Sanofi, Mr. Wallace served in HR leadership positions at BASF Corporation, GE Healthcare and Pratt & Whitney. He was a Commissioned Officer in the U.S. Air Force and retired in June 2008 after 21 years of service. He holds an M.B.A. from Rensselaer Polytechnic Institute and a B.S. degree in Manufacturing Engineering from Central Connecticut State University. Tina Ventura brings nearly 25 years of experience in global health care investor relations and communications to Madrigal. Before joining Madrigal, she was Chief Investor Relations Officer at Horizon Therapeutics (acquired by Amgen) where she led the company's investor relations efforts to shape its investment identity as a rare disease-focused biotech, build and develop its investor base and drive shareholder value creation. Prior to Horizon, Ventura was Divisional Vice President, Investor Relations, Abbott, spending 16 years at the diversified healthcare company in positions of increasing responsibility in communications and investor relations. She has been ranked a number-one IR professional by Institutional Investor. Ventura holds an M.B.A. from Loyola University and a B.A. degree in Communications from Northwestern University. About Madrigal Pharmaceuticals Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) is a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), a liver disease with high unmet medical need. Madrigal’s lead candidate, resmetirom, is a liver-directed THR-β agonist oral therapy that is designed to target key underlying causes of NASH. For more information, visit . Investor Contact Tina Ventura, Madrigal Pharmaceuticals, Inc., IR@madrigalpharma.com Media Contact Christopher Frates, Madrigal Pharmaceuticals, Inc., media@madrigalpharma.com