Scholar Rock (NASDAQ: SRRK) has reported positive results from the Phase 2 embraze proof-of-concept trial, demonstrating the statistically significant preservation of lean mass with apitegromab during tirzepatide-induced weight loss.
Here are the key findings from the trial:
- Patients receiving apitegromab with tirzepatide over 24 weeks showed 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.
- 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.
- A higher quality of weight loss was observed for patients receiving apitegromab with tirzepatide (85% fat mass/15% lean mass) compared to tirzepatide alone (70% fat mass/30% lean mass).
The trial demonstrated that 30% of total weight loss with tirzepatide alone was due to lean mass loss. Apitegromab therapy (10 mg/kg) with tirzepatide preserved an additional 4.2 pounds (1.9 kilograms) or 54.9% of lean mass compared to tirzepatide alone, leading to higher quality weight loss.
Dr. Akshay Vaishnaw, President of R&D at Scholar Rock, commented that the results validated their hypothesis that their platform of highly selective myostatin inhibitors has the potential to support healthier weight loss for patients on glp therapies by safely preserving lean mass.
The analysis based on participants who completed treatment and had a week 24 dual-energy X-ray absorptiometry (DEXA) scan showed that lean mass and fat mass were calculated, and body weight was measured with a scale.
Moreover, it was noted that apitegromab was generally well tolerated, and the encouraging safety profile was consistent with the safety profile observed in prior clinical studies.
The company announced that it remains on track to file an Investigational New Drug (IND) application for SRK-439 in the second half of the year to support the first in human study.
Scholar Rock will hold an investor conference call today to discuss these findings and will be presenting additional data from the trial at upcoming medical congresses.
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 Phase 2 embraze trial was designed to assess the ability to preserve lean body mass associated with tirzepatide-induced weight loss in patients with obesity or overweight. The 24-week data demonstrated the preservation of lean mass, thus improving the quality of weight loss with tirzepatide therapy.
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 that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need, with a focus on neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role. The market has reacted to these announcements by moving the company's shares 15.94% to a price of $36.115. For the full picture, make sure to review Scholar Rock's 8-K report.
