공고 • Jul 28
Gubra A/S Announces Initiation Of Ambitious Phase 1/2a Clinical Trial Of Lead Asset GUB-UCN2 In Obesity Gubra A/S announced the initiation of the first-in-human trial of GUB-UCN2, the company’s next mega program, with the first participant completing the first visit. The Phase 1/2a clinical trial is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of GUB-UCN2, with a particular focus on muscle volume and muscle function. The Phase 1/2a trial will enroll a total of approximately 188 healthy participants and individuals living with obesity, with and without related comorbidities. The trial consists of three parts: a single ascending dose (SAD) component, a multiple ascending dose (MAD) component, and a multiple dose (MD) component with a treatment duration of up to 16 weeks. The trial will investigate GUB-UCN2 as both a standalone therapy and in combination with incretin-based therapy for obesity. Data from the trial are expected to be released on a sequential basis, with initial data from the SAD study in healthy volunteers, including safety, tolerability, and pharmacokinetic assessments, expected in the first half of 2027. The trial is strategically designed to maximize asset value by generating multidimensional clinical data early in development and preparing the regulatory path for further development. GUB-UCN2 has delivered strong and comprehensive preclinical data. Results have shown that GUB-UCN2 substantially and selectively lowers fat mass and increases muscle mass when administered alone and in combination with incretin-based therapy. In combination with a GLP-1 receptor agonist, GUB-UCN2 completely prevented the lean mass loss typically seen with GLP-1 receptor agonist-based therapies and enhanced fat mass reduction. GUB-UCN2 also reversed lean mass loss after prior GLP-1 exposure, positioning it as both a protective and restorative therapy in treatment combination regimens. Beyond body composition, UCN2 has delivered improvements of cardiac and renal function in preclinical models. UCN2 (Urocortin 2), is a 38 amino acid neuropeptide that selectively binds to the corticotropin-releasing hormone receptor 2 (CRHR2). Activation of CRHR2 by UCN2 induces a reprogramming of skeletal muscle toward an exercise-like phenotype, leading to a favorable shift in body composition characterized by increased muscle mass and reduced fat mass. Mechanistically, UCN2 acts directly on CRHR2 receptors expressed in skeletal muscle, where it stimulates muscle growth and enhances performance. This effect is mediated in part through increased protein synthesis within muscle tissue. In parallel, UCN2 reduces intramuscular fat accumulation, contributing to improved muscle quality and metabolic efficiency. Additionally, UCN2 enhances insulin sensitivity in skeletal muscle, further supporting metabolic health and glucose homeostasis. 공고 • Jun 16
Gubra Announces Appointment of Lena Moran-Adams as Group General Counsel, Effective June 16, 2026 Gubra announced the appointment of Lena Moran-Adams as the company’s new Group General Counsel, effective June 16, 2026. Lena Moran-Adams joined Gubra as its new Group General Counsel responsible for driving legal strategy and execution across its business. Prior to joining Gubra, she held senior legal leadership roles at Telix Pharmaceuticals (Group General Counsel), Gilead Sciences (Head of Legal & Business Conduct, Intercontinental Region), Novartis (Global Head Legal) and Bristol Myers Squibb (Regional Senior Legal Counsel). Lena is admitted to practice law across three continents and brings more than 25 years of experience leading legal, compliance, intellectual property and corporate governance strategy teams across multiple regions and globally. Her background spans multiple practice areas, jurisdictions, and business models, ranging from start-up biotechnology companies to multinational blue-chip biopharmaceutical organizations. 공고 • Mar 04
Gubra A/S, Annual General Meeting, Mar 26, 2026 Gubra A/S, Annual General Meeting, Mar 26, 2026, at 10:00 Romance Standard Time. Location: horsholm kongevej 11b, 2970, Denmark 공고 • Jan 08
Amylyx Pharmaceuticals, Inc. Announces Nomination of Amx0318 as A Novel, Long-Acting Glp-1 Receptor Antagonist Amylyx Pharmaceuticals, Inc. announced the selection of AMX0318, a long-acting glucagon-like peptide-1 (GLP-1) receptor antagonist, as a development candidate for post-bariatric hypoglycemia (PBH) and other rare diseases. AMX0318 was identified through a research collaboration with Gubra A/S. AMX0318 has completed extensive preclinical evaluation, including stability, solubility, potency, in vivo pharmacokinetics and pharmacodynamics, and in vivo tolerability studies. Amylyx expects the program to advance into investigational new drug (IND)-enabling studies later this year, with an IND targeted for 2027, pending successful completion of IND-enabling studies. Under the terms of the research collaboration, Gubra is eligible to receive more than $50 million in success-based development and commercialization milestones plus mid-single digit royalties on worldwide net sales. The selection and handover of the development candidate will provide milestone payments of $4 million to Gubra. 공고 • Jan 05
Gubra Announces Executive Changes Gubra announced the appointment of Thomas Langenickel, M.D., as Chief Medical and Development Officer (CMDO) effective January 5, 2026. Dr. Langenickel brings more than two decades of experience in big pharma and biotech, spanning drug discovery, translational medicine, and clinical development. In his new role, he will join Gubra’s Leadership Team and guide the company’s preclinical and clinical development strategy as its pipeline advances toward key milestones. Dr. Langenickel most recently served as Chief Medical Officer at Ethris, where he led the development of early clinical assets in respiratory and infectious diseases. His prior experience includes senior roles at Novartis as Executive Director of Translational Medicine and Profiling, and at Bristol Myers Squibb as Medical Director. He earned his M.D. from Humboldt University of Berlin and completed a postdoctoral fellowship in vascular biology at the National Heart, Lung, and Blood Institute, NIH (USA). Gubra also extends its gratitude to Dr. Mads Axelsen, who retired in December after serving as CMO. His leadership and contributions have been instrumental in shaping Gubra's development organization and supporting the company's growth.