Shares of Scholar Rock (SRRK) are up nearly 13% at $35.18 in premarket trading on Wednesday, following positive results from its EMBRAZE trial.
EMBRAZE is a phase II proof-of-concept trial evaluating the company's lead drug candidate Apitegromab in combination with Lilly's Zepbound, an approved GLP-1 receptor agonist, in patients with obesity or overweight.
Glucagon-like peptide-1 (GLP-1) therapies like Zepbound (tirzepatide) have been an effective and important innovation for individuals living with obesity and cardiometabolic disorders. However, they are associated with significant reductions in lean body mass, including muscle, leading to unwanted health risks.
The EMBRAZE trial has now demonstrated that Apitegromab in combination with a GLP-1 receptor agonist can effectively address this critical challenge of muscle loss during weight management.
According to the EMBRAZE trial results, a combination therapy of Apitegromab with Zepbound for over 24 weeks preserved an additional 4.2 pounds (1.9 kilograms) or 54.9% of lean mass compared to Zepbound alone, leading to higher quality weight loss. Apitegromab with Zepbound was generally well tolerated by participants.
The combination group lost 12.3% of their body weight compared to 13.4% for Zepbound alone. While the Zepbound-only group lost slightly more total weight, the quality of that weight loss was much better in the combination group, the company noted.
Additional data from the study are expected to be presented at upcoming medical congresses.
Scholar Rock's Apitegromab is under FDA review for the proposed indication of Spinal Muscular Atrophy, with a decision anticipated on September 22, 2025.
Spinal muscular atrophy, or SMA, is a rare, genetic neuromuscular disease characterized by the loss of motor neurons, atrophy of the voluntary muscles of the limbs and trunk, and progressive muscle weakness. An estimated 30,000 to 35,000 people in the United States and Europe are afflicted by SMA.
SRRK first caught our attention on September 27, 2023, when the stock was trading at $6.45. We alerted readers again on October 7, 2024, after the stock had surged to $26.34.
SRRK has traded in a range of $6.76 to $46.98 in the last 1 year. The stock closed yesterday's trading at $31.15, down 3.05%.
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