SRK-439 / Scholar Rock - LARVOL DELTA

Pharmacological intervention: Challenges and promising outcomes for fat loss and preservation of lean body mass in the treatment of overweight and type 2 diabetes. (PubMed, Diabetes Obes Metab) - "Activin II receptor inhibition with bimagrumab demonstrated significant preservation and increases in LBM, along with FM reduction, in both preclinical and phase 2 studies in individuals with overweight and T2D. Similar effects were observed for myostatin and activin A inhibitors (trevogrumab, garetosmab), latent myostatin inhibitors (apitegromab, SRK-439), and Selective Androgen Receptor Modulators (enobosarm)...Pharmacological adjunct therapies show potential for improving body composition and physical function during GLP-1 RA-induced weight loss. Preliminary findings are promising, but larger, controlled trials are necessary to confirm efficacy and safety before clinical implementation can be considered."

Journal • Review • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Scholar Rock Reports Second Quarter 2025 Financial Results and Highlights Business Progress (Businesswire) - "Scholar Rock remains on track to file an IND application for SRK-439 to support the first in human study in the second half of 2025."

IND • Obesity

The Anti-myostatin Antibody SRK-439 Improves Grip Strength during GLP-1RA Treatment in a Mouse Model of Obesity (ADA 2025) - "These results demonstrate that even short-term administration of SRK-439 can improve strength during GLP-1RA-induced weight loss. Long term studies may better assess the effects of maintaining lean mass on exercise performance."

Preclinical • Metabolic Disorders • Obesity

Scholar Rock Reports First Quarter 2025 Financial Results and Highlights Business Progress (Businesswire) - "Topline data to be reported in June 2025 from the Phase 2 EMBRAZE proof-of-concept trial. The trial is designed to evaluate the safety and efficacy of apitegromab in preserving muscle mass in adults who are overweight or obese and receiving tirzepatide....IND application for SRK-439 to support the first in human study remains on track and is expected to be filed in Q3 2025."

IND • P2 data • Obesity

Scholar Rock Reports Full Year 2024 Financial Results and Highlights Business Progress (Businesswire) - "Apitegromab: In anticipation of regulatory approvals, Scholar Rock is planning for a U.S. commercial launch in 4Q 2025, with European launch to follow....Plans to initiate Phase 2 OPAL clinical trial in SMA patients under two years of age in 3Q 2025....SRK-439: Topline data expected in the second quarter of 2025 from the Phase 2 EMBRAZE proof-of-concept trial....IND application for SRK-439 for the treatment of obesity in patients on standard of care GLP-1 RAs expected to be filed in 3Q 2025....The Company’s outstanding debt balance is unchanged at $50 million. The new facility provides the Company with access to an additional $50 million at its discretion through December 31, 2025. An additional $50 million would be available to the Company upon FDA approval of apitegromab in SMA..."

Commercial • IND • Launch US • New P2 trial • P2 data • CNS Disorders • Metabolic Disorders • Muscular Atrophy • Obesity

SRK-439 Selectively Inhibits Myostatin to Promote Healthy Body Composition During Metformin Therapy (OBESITY WEEK 2024) - "Selectively inhibiting myostatin in combination with metformin administration increases lean mass and reduces fat mass in DIO mice. This supports the use of SRK-439 to promote healthy body composition during treatment for obesity and type 2 diabetes."

Clinical • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Scholar Rock Reports Second Quarter 2024 Financial Results and Highlights Business Progress (Businesswire) - "Remains on track to report topline data from pivotal Phase 3 SAPPHIRE trial in patients with Spinal Muscular Atrophy (SMA) in 4Q 2024...Phase 2 EMBRAZE proof-of-concept trial enrolling ahead of schedule, topline data expected in 2Q 2025...The Company plans to file an IND for SRK-439 for the treatment of obesity in 2025."

IND • P2 data • P3 data: top line • CNS Disorders • Metabolic Disorders • Muscular Atrophy • Obesity

The Antimyostatin Antibody SRK-439 Promotes Healthy Body Composition in Combination with GLP-1RAs in a Mouse Model of Obesity (ADA 2024) - "Mice that received sema + SRK-439 had 18.0% body fat, compared to 28.7% in the sema + IgG group (p<0.05) and circulating leptin was lower in the sema + SRK-439 group when compared to the sema + IgG group (21.7 vs 37.9 ng/mL, p<0.01). These results demonstrate that SRK-439 maintains a healthy body composition during GLP-1RA-induced weight loss."

Combination therapy • Preclinical • Metabolic Disorders • Obesity • LEP

Scholar Rock Presents New Preclinical Data Demonstrating Potential Benefit of SRK-439 for Healthy Weight Loss Management (Businesswire) - "Scholar Rock...today announced new preclinical data showing the potential of SRK-439 to preserve lean mass and improve metabolic health as part of healthy weight loss. These data showed that SRK-439 maintained lean mass and improved fat mass loss when used in combination with a GLP-1 receptor agonist (GLP-1 RA; in separate experiments with semaglutide and liraglutide) in diet-induced obesity (DIO) mice. SRK-439 treatment also led to incremental lowering of fasting glucose beyond the levels seen with semaglutide alone. Detailed results were presented by Melissa Fulham, PhD, of Scholar Rock, at the Keystone Symposia’s Obesity: Causes and Consequences meeting in Vancouver, BC, Canada on February 5."

Preclinical • Metabolic Disorders • Obesity

Scholar Rock Announces Presentation of New Preclinical Data Evaluating SRK-439 in Obesity at Keystone Symposia (Businesswire) - "Scholar Rock...today announced a poster presentation at the upcoming Keystone Symposia’s Obesity: Causes and Consequences meeting, to be held February 4 – 6, 2024, in Vancouver, BC, Canada. Scholar Rock will present preclinical data evaluating SRK-439 in combination with GLP-1 receptor agonists in obesity to maintain lean mass and enhance fat mass loss." "

Preclinical • Metabolic Disorders • Obesity

Scholar Rock Reports Third Quarter 2023 Financial Results and Highlights Business Progress (Businesswire) - "Plans to initiate a Phase 2 proof-of-concept trial with apitegromab in combination with a GLP-1 receptor agonist (GLP-1 RA) in obesity in 2024. 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 RA in 2024, subject to IND clearance. Data from the clinical trial are expected in mid-2025 and will be used to inform further clinical development of SRK-439. The Company plans to file an IND for SRK-439 for the treatment of obesity in 2025."

IND • New P2 trial • P2 data • Metabolic Disorders • Obesity