Scholar Rock (NASDAQ: SRRK) has reported positive results from the phase 2 Embraze trial, demonstrating statistically significant preservation of lean mass with apitegromab during tirzepatide-induced weight loss. The trial showed that patients receiving apitegromab with tirzepatide over 24 weeks exhibited a 54.9% preservation of lean mass (+4.2 lbs of lean mass) versus tirzepatide alone (p=0.001).
Patients receiving apitegromab with tirzepatide over 24 weeks lost 18.8 lbs of fat mass while those on tirzepatide alone lost 17.7 lbs of fat mass. Additionally, patients receiving apitegromab with tirzepatide over 24 weeks lost 12.3% of body weight while those on tirzepatide alone lost 13.4% of body weight.
The trial also revealed a higher quality of weight loss for patients receiving apitegromab with tirzepatide (85% fat mass/15% lean mass) compared to tirzepatide alone (70% fat mass/30% lean mass).
The company's president of R&D, Dr. Akshay Vaishnaw, expressed satisfaction with the trial's results, stating that the platform of highly selective myostatin inhibitors has the potential to support healthier weight loss for patients on GLP therapies by safely preserving lean mass. He also highlighted the exciting potential of the platform in studying a range of neuromuscular diseases with high unmet need.
The Embraze trial, designed to assess the ability to preserve lean body mass associated with tirzepatide-induced weight loss in patients with obesity or overweight, demonstrated proof-of-concept for a highly selective, anti-myostatin antibody to preserve lean mass and improve the quality of weight loss with tirzepatide therapy.
The 24-week data from the trial demonstrated that apitegromab with tirzepatide preserved an additional 4.2 pounds (1.9 kilograms) or 54.9% of lean mass compared to tirzepatide alone. Moreover, the incidence of adverse events was generally similar between apitegromab and placebo, with no subjects experiencing serious adverse events (SAEs) or discontinuations considered to be related to apitegromab treatment, and no deaths reported.
The company is set to host a conference call to discuss the results and share further insights into the trial. Additionally, Scholar Rock is on track to file an IND application for SRK-439 in the second half of the year to support the first in human study.
Apitegromab is an investigational fully human monoclonal antibody inhibiting myostatin activation by selectively binding the pro* and latent forms of myostatin in the skeletal muscle. It is the first muscle-targeted treatment candidate in spinal muscular atrophy (SMA) to demonstrate clinical success in a pivotal phase 3 clinical trial. The U.S. Food and Drug Administration (FDA) has granted fast track, orphan drug, and rare pediatric disease designations to apitegromab for the treatment of SMA.
Moreover, SRK-439 is a novel, preclinical, investigational, subcutaneous myostatin inhibitor that has high in vitro affinity for pro* and latent myostatin and maintains myostatin specificity. The company intends to explore SRK-439’s potential in various neuromuscular disorders.
Scholar Rock is a biopharmaceutical company focused on developing and commercializing apitegromab for patients with spinal muscular atrophy (SMA) and additional severe and debilitating neuromuscular diseases. The company aims to deliver life-changing therapies for people with serious diseases that have high unmet need by leveraging its proprietary platform to develop novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. The market has reacted to these announcements by moving the company's shares -3.05% to a price of $31.15. For the full picture, make sure to review Scholar Rock's 8-K report.
