Scholar Rock announced it plans to advance SRK-439, a novel investigational myostatin inhibitor for the treatment of obesity towards an investigational new drug application (IND) submission in 2025. As part of the Company?s strategy to advance the development of SRK-439, it plans to initiate a Phase 2 proof-of-concept trial with apitegromab in combination with a GLP-1 receptor agonist (GLP-1 RA) in 2024, subject to IND acceptance. Data from the clinical trial are expected in mid-2025 and will be used to inform further clinical development of SRK-439.

Cardiometabolic program: Muscle plays a key role in metabolic functions and energy homeostasis. Leveraging proven expertise in antimyostatin and its effect on increasing muscle mass, the Company has been developing myostatin-selective inhibitors to address cardiometabolic disorders, including obesity. Scholar Rock?s platform has generated multiple antibody candidates, including apitegromab, that selectively target pro- and latent forms of myostatin.

The Company believes the selectivity of these antibody candidates enables a favorable risk-benefit profile for patients with cardiometabolic disorders. SRK-439, a novel antimyostatin antibody candidate developed by Scholar Rock, has attractive properties, including high in vitro affinity for pro- and latent myostatin, maintenance of myostatin specificity (i.e., no GDF11 or Activin-A binding), and robust in vivo efficacy in preclinical models. Studies in diet-induced obese mice showed that SRK-439 in combination with GLP-1 receptor agonist (GLP-1 RA) achieved: Dose-dependent reversal of lean mass loss during GLP-1 RA-mediated weight loss; and Enhancement of fat mass loss mediated by GLP-1 RA treatment.