Kallyope, Inc.

Kallyope has canned one of its investigational migraine medicines, Endpoints News has learned. The New York City-based biotech terminated a Phase 2a trial of its experimental migraine drug, dubbed K-645, according to an update to the US federal trials database this week. Kallyope discontinued development of K-645 to “focus our resources on advancing other clinical candidates with the potential to alter the treatment landscape, including elismetrep and our growing metabolic portfolio,” a company spokesperson wrote in an emailed statement to Endpoints News on Tuesday evening. Elismetrep is Kallyope’s other clinical-stage migraine medicine. The drug completed a Phase 2b in patients with moderate or severe migraine in August. The culling of K-645 marks the second mid-stage setback for Kallyope’s pipeline this year. The company reported underwhelming results for its experimental obesity pill in February. The migraine study was “stopped for futility based on an interim analysis of efficacy,” meaning the drug did not reach certain clinical expectations, according to the trial update. The primary goal of the trial was “pain freedom” two hours after receiving the drug. Secondary measurements included pain relief, light sensitivity and absence of nausea, among others. The study enrolled 134 patients, slightly more than its original aim of 120, across more than a dozen sites in the US. Kallyope has not yet released Phase 2b data from the 431-person study of elismetrep, which also goes by the codename K-304. The experimental pill was previously developed by Mitsubishi Tanabe Pharma, the centuries-old Japanese drugmaker now owned by Bain Capital. Tanabe previously tested elismetrep, a TRPM8 inhibitor , in a Phase 2 involving patients with painful diabetic peripheral neuropathy. The length of Kallyope’s runway, or how long it can continue developing elismetrep and a suite of preclinical projects, is unclear. The biotech last disclosed a $236 million Series D in February 2022. At the time, CEO Jay Galeota told Endpoints that the funding would keep Kallyope’s lights on for about three years. The biotech then reportedly eyed an IPO, Bloomberg News reported in January 2024. Kallyope’s gut-brain axis mission has been funded by well-known investors such as Mubadala Investment Company, The Column Group, Bill Gates, Lux Capital, Polaris Partners and others. Its board chair is former Roche CEO Franz Humer. In recent years, Kallyope has remained relatively quiet. The startup’s only public update since the beginning of 2024 was an announcement that Novo Nordisk licensed a ligand for further development in a potential obesity treatment.

After disappointing data for its weight-loss drug candidates earlier this year, Kallyope moved neurological disorders higher on its list of priorities, but those efforts have already encountered a setback. In an update on ClinicalTrials.gov this week, the biotech revealed that a mid-stage study of its experimental migraine drug K-645 was terminated after an interim efficacy analysis found it was unlikely to succeed.The study compared two oral dose levels of K-645, which is based on the company's Klarity discovery engine, and had enrolled 134 patients with multiple acute migraine attacks. The primary endpoint was measuring the percentage of participants with pain freedom at two-hours post-dose.According to Kallyope's website, the Klarity platform integrates single-cell transcriptional sequencing and circuit mapping, as well as optogenetics and chemogenetics. The methods "allow highly selective activation of a specific neuron or set of neurons so that we can observe the physiology," the company says.The setback for K-645 now shifts focus to elismetrep (K-304), another migraine candidate that completed Phase II in August with a much larger 431-patient data set, according to ClinicalTrials.gov. That study was comparing elismetrep — an oral inhibitor of TRPM8 originally being developed by Mitsubishi Tanabe Pharma — versus placebo as a treatment for moderate or severe migraine.Kallyope has not disclosed its future plans for K-645, leaving elismetrep as the most advanced asset in its migraine pipeline. It has another candidate, K-745, currently in preclinical testing.The company's pivot toward neurological disorders earlier this year follows disappointing obesity results, when the combination of two oral "nutrient receptor agonists" K-757 and K-833 fell well short of the efficacy other oral contenders have shown, despite having a more tolerable gastrointestinal (GI) profile. K-833 was dropped from Kallyope's pipeline, leaving K-757 as the sole disclosed metabolic candidate.That stumble followed momentum from a $236-million series D raise in 2022, which had been tied largely to its metabolic and GI programmes.

10月8日，纽约，利用神经回路（neural circuits）恢复疾病免疫稳态的生物技术公司Nilo Therapeutics宣布完成1.01亿美元的A轮融资走出隐身模式，由The Column Group（TCG）、DCVC Bio和Lux Capital领投，盖茨基金会和Alexandria Venture Investments参与。与此同时Nilo宣布任命Kim Seth博士为首席执行官兼董事会董事。 Nilo由世界领先的科学家Charles Zuker教授（哥伦比亚大学）、Ruslan Medzhitov教授（耶鲁大学）和Steve Liberles教授（哈佛大学）与TCG合作创建，旨在将神经免疫学的突破性科学见解转化为新的治疗策略。Seth博士与首席科学官Laurens Kruidenier博士一起领导公司从隐形过渡到下一个增长阶段。这笔融资为Nilo在纽约市建立实验室、发展跨学科研发团队以及推进公司的临床前项目提供了动力。 这家生物技术公司的推出是著名生命科学投资者对Charles Zuker教授的又一次信任。大约10年前，Zuker创立的另一家名为Kallyope的公司从包括Lux和The Column group在内的最初支持者那里获得了4400万美元的资金。Kallyope的研究集中在“肠脑轴”上。 Nilo正在开发利用神经回路集中恢复免疫稳态的药物，为免疫调节提供了一种差异化的方法，并超越了传统的免疫抑制。该公司基于Charles Zuker教授（哥伦比亚大学首席研究员和霍华德·休斯医学研究所研究员）实验室的开创性科学发现，该发现确定了调节全身免疫激活和炎症的特定迷走神经神经元。通过靶向这些中枢“主调节器”脑体回路，Nilo正在采用其新颖的治疗方法来协调调节多种免疫途径，降低治疗耐药性的风险，并扩大对大量未满足需求的自身免疫和炎症性疾病的潜在影响。 Seth博士拥有超过25年的生物制药行业经验，曾在多家早期和上市生物技术公司以及大型制药公司担任运营职务。他在公司建设、战略和研发运营、业务发展、金融和资本市场方面拥有广泛的专业知识。在加入Nilo之前，Seth博士曾担任精准肿瘤学公司Repare Therapeutics的首席商务官，他是该公司执行领导团队的成员，并在将公司从A轮融资前扩展到B轮融资和首次公开募股方面发挥了重要作用。他负责建立公司的美国业务运营，并领导业务发展，通过一系列全球平台、资产和临床合作伙伴关系产生了超过2.5亿美元的融资，总潜在价值超过40亿美元。在加入Repare之前，Seth博士曾在包括辉瑞在内的多家生物制药公司的BD、战略和运营部门担任领导职务，并且是高盛的大型制药/特种制药研究分析师。他在哈佛大学以优异的成绩获得经济学学士学位，并在哈佛大学医学系获得神经生物学博士学位。 Laurens Kruidenier博士，首席科学官，一位成就卓著的免疫学和药物发现领导者。Kruidenier博士曾在Cellarity和Prometheus Biosciences（被默沙东收购）担任首席科学官，在那里他推进了多种创新疗法，从概念到临床治疗自身免疫和炎症性疾病。在武田制药和葛兰素史克的职业生涯早期，他领导了临床前和发现研究团队以及业务发展战略。他在莱顿大学获得了免疫学博士学位，他的研究发表在包括《自然》在内的领先科学期刊上。 Nilo Therapeutics首席科学官Laurens Kruidenier博士说：“Nilo正处于变革时刻。Kim的领导和经验将加速我们的使命，将突破性的神经免疫学转化为药物，使各种免疫驱动疾病的患者受益。” The Column Group管理合伙人Tim Kutzkey博士表示：“我们很高兴欢迎Kim担任首席执行官。Kim在指导公司从最初阶段到首次公开募股，以及成功推进项目方面有着良好的记录，他带来了广度和远见。他对将大胆的科学转化为突破性药物的热情使他成为补充Laurens科学领导力并带领Nilo进入下一个增长阶段的理想合作伙伴。” Nilo Therapeutics首席执行官Kim Seth表示：“很荣幸能加入Nilo才华横溢、敬业的团队。我们与世界级的科学创始人Laurens和投资者一起，正在建立一家能够提供新一代疗法的公司，这些疗法利用大脑免疫轴来改变自身免疫和炎症疾病的治疗方式。” 关注下方公众号，带你看世界!