An Open-Label, Fixed-Sequence, Drug-Drug Interaction Study in Healthy Participants to Evaluate the Effect of AGMB-129 on the Pharmacokinetics of Midazolam, a Sensitive Index Substrate of CYP3A4
This is a single-center, open-label, fixed-sequence, Phase 1 study in healthy adult participants to evaluate the effect of AGMB-129 200 mg twice daily (BID) on the PK of a single dose of MDZ in healthy participants. A total of 14 participants will be enrolled and will receive study intervention in a fixed-sequence scheme. All IP will be administered orally and in fed conditions. The total duration of involvement for each participant, screening through follow-up, will be approximately 6 weeks.
A Phase 2a, Randomized, Placebo-controlled, Double-blind Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of AGMB-129 in Patients With Fibrostenotic Crohn's Disease
The goal of this clinical trial is to learn about the safety, pharmacokinetics and pharmacodynamics of AGMB-129 in patients with Crohn's disease. The main questions it aims to answer are: is AGMB-129 safe and well tolerated in these patients? what does the body do to the drug (pharmacokinetics)? what does the drug do to the body (pharmacodynamics)? The participants will be in the study for a total duration of up to 19 weeks, including a 5-week screening period, a 12-week double-blind, placebo-controlled treatment period where they will receive either a high or low dose or placebo (1:1:1), and 2-week safety follow-up period
▎药明康德内容团队编辑Agomab Therapeutics今天宣布完成由Fidelity Management & Research领投的1亿美元C轮融资。获得资金将用于支持其主打候选疗法AGMB-129的2a期临床试验，用于治疗纤维化狭窄性克罗恩病（Fibrostenosing Crohn’s Disease，FSCD）。AGMB-129是一款肠道限制型ALK5小分子抑制剂，已经获得美国FDA授予的快速通道资格。参加本轮融资的投资机构还包括新投资者EQT Life Sciences，Canaan和Dawn Biopharma（由KKR控制的投资平台），以及现有投资者。纤维化狭窄发生在高达50%克罗恩病患者中，是肠切除手术的主要原因，然而目前尚无治疗FSCD的获批疗法。今年早些时候，Agomab公布的积极1期临床结果显示，在所有试验剂量下，单次和多次口服AGMB-129的安全性和耐受性良好，证实胃肠道限制性暴露。此外，获得的资金将用于推进和扩展Agomab的研发管线，包括AGMB-447，一种肺限制的ALK5小分子抑制剂，治疗特发性肺纤维化。以及AGMB-101和AGMB-102，用于治疗纤维化和退行性疾病的cMET激动性抗体。▲Agomab的研发管线（图片来源：Agomab官网）Agomab致力于通过靶向与纤维化相关的重要生长因子TGFβ和HGF的信号通路，治疗多种纤维化疾病。该公司曾入选2022年度生物技术猛公司（Fierce 15），并与辉瑞达成合作共同研发AGMB-129。大家都在看药明康德为全球生物医药行业提供一体化、端到端的新药研发和生产服务，服务范围涵盖化学药研发和生产、生物学研究、临床前测试和临床试验研发、细胞及基因疗法研发、测试和生产等领域。如您有相关业务需求，欢迎点击下方图片填写具体信息。▲如您有任何业务需求，请长按扫描上方二维码，或点击文末“阅读原文/Read more”，即可访问业务对接平台，填写业务需求信息▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料： Agomab Raises $100 Million Series C to Advance Fibrosis-focused Pipeline. Retrieved October 11, 2023, from https://www.agomab.com/wp-content/uploads/2023/10/20231011_Agomab-Series-C_FINAL.pdf#new_tab免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新
Some of Agomab Therapeutics' new cash will be used to "enable strategic expansion of the organization."
A week after entering its lead asset into a phase 2 trial for a type of Crohn’s disease, Agomab Therapeutics has secured $100 million in series C financing to power up its pipeline.
The Belgian biotech will use part of the new capital to fund the trial, which will see 36 patients with fibrostenosing Crohn’s given the ALK5 inhibitor, dubbed AGMB-129. The gut-restricted small-molecule inhibitor has also recently received an FDA fast-track tag, having been shown to be safe at all dose levels tested in a phase 1 study earlier this year.
The latest funding round was led by Fidelity Management & Research Company with new investors hopping aboard including EQT Life Sciences and Dawn Biopharma, alongside existing backers. It follows a $40.5 million extension to a series B round led by Pfizer last year.
Agomab has been busy since unveiling with 21 million euros ($22 million) in 2019 with the aim of developing agonistic monoclonal antibodies—or “agomAbs”—that can potentially treat a variety of diseases. Based in Ghent, Belgium, the biotech was founded upon the work of Paolo Michieli, Ph.D., who has researched hepatocyte growth factor, or HGF, at the University of Torino for more than two decades. HGF plays a role in cell functions such as proliferation, survival and differentiation and can promote wound healing and tissue regeneration.
In 2021, Agomab bought Origo Biopharma, adding small-molecule drug candidates that target the transforming growth factor beta, including AGMB-129. The deal shifted the focus of Agomab, catching the attention of Pfizer and leading to the biotech gaining a coveted place on the Fierce 15 list in 2022.
The company’s hopes are that AGMB-129 can be used in combination with other Crohn’s drugs to help tamp down the disease and stop the scarring in those with fibrostenotic disease. This could be a sizable market—around 800,000 people are estimated to have Crohn’s in the U.S., around half of whom will be impacted by the fibrostenotic form.
The biotech will also channel some of its nine-figure fundraise across the rest of its pipeline, which includes an inhaled ALK5 inhibitor called AGMB-447 for idiopathic pulmonary fibrosis, as well as the MET agonists AGMB-101 and AGMB-102, which are being targeted at organ failure and fibrotic indications, respectively.
Some cash will also be used to “enable strategic expansion of the organization and fund general corporate purposes,” Agomab added in the release.
Agomab Therapeutics on Wednesday closed a Series C financing round worth $100 million, which the company will use to advance its fibrosis-focused pipeline led by AGMB-129. Chief executive Tim Knotnerus said “we…have secured the funding required to conduct clinical studies for multiple drug candidates.”The company recently started the Phase IIa STENOVA study of AGMB-129 - a gut-restricted small-molecule inhibitor of ALK5 – in patients with fibrostenosing Crohn’s disease. Earlier this year, Agomab reported Phase I results showing that single- and multiple-dosing of the oral drug was safe and well-tolerated and confirming gastro-intestinal (GI)-restricted exposure.In addition, the proceeds of the financing will be used to advance Agomab’s portfolio of growth factor-targeting drug candidates, including AGMB-447, a small-molecule lung-restricted inhibitor of ALK5 for the treatment of idiopathic pulmonary fibrosis, and the cMET agonistic antibodies AGMB-101 and AGMB-102 for the treatment of fibrotic and degenerative disorders. The company said the funds will also allow “strategic expansion.”The financing round was led by Fidelity Management & Research Company with participation from EQT Life Sciences, Canaan and KKR’s Dawn Biopharma. In conjunction with the funding, EQT’s Felice Verduyn - van Weegen will join Agomab’s board.In 2019, Agomab raised €21 million ($22.3 million) in a Series A financing, pulling in $74 million via a Series B round in 2021, which was expanded the following year by $40.5 million.