CAMBRIDGE, Mass. - Scholar Rock (NASDAQ: SRRK), a biopharmaceutical company, has initiated a Phase 2 EMBRAZE proof-of-concept trial to evaluate apitegromab's ability to preserve lean muscle mass in obese individuals undergoing GLP-1 receptor agonist therapy. The trial's initiation and new preclinical data on SRK-439, another myostatin inhibitor, were announced ahead of the company's Investor Event today in New York City.
Apitegromab, a selective myostatin inhibitor, is being tested for its safety and efficacy in maintaining lean muscle mass, which could be a significant advancement in the treatment of obesity. The EMBRAZE trial, which started ahead of schedule, will include 100 overweight or obese adults without diabetes, all receiving a GLP-1 receptor agonist.
Participants will be randomized to receive either apitegromab or a placebo intravenously every four weeks for 24 weeks. The primary endpoint of the study is the change from baseline at Week 24 in lean mass, measured by dual-energy X-ray absorptiometry.
The company also revealed preclinical findings showing that SRK-439 is potentially more potent than an anti-ActRII antibody in preserving lean mass in diet-induced obesity (DIO) mice models. SRK-439 demonstrated significant lean mass preservation at all tested doses when used with semaglutide, a GLP-1 receptor agonist. Notably, a dose of 1mg/kg of SRK-439 showed equivalent lean mass preservation to a 20mg/kg dose of the anti-ActRII antibody.
Dr. Mo Qatanani, Chief Scientific Officer at Scholar Rock, highlighted the importance of selectivity in mitigating safety concerns and believes that the new data supports the hypothesis that selective latent myostatin inhibition could maintain lean muscle mass more effectively and safely than less selective approaches.
Primary data from EMBRAZE are expected in mid-2025 and will guide the development of SRK-439, with an anticipated Investigational New Drug (IND) filing in the same year. SRK-439 is being developed for cardiometabolic disorders, including obesity, and is yet to be approved by the FDA or any other regulatory agency.
InvestingPro Insights
As Scholar Rock (NASDAQ: SRRK) embarks on the Phase 2 EMBRAZE trial for apitegromab, the company's financial health and market performance provide critical context for investors monitoring its progress. According to InvestingPro data, Scholar Rock holds a market capitalization of approximately $978.58 million, reflecting its position in the biopharmaceutical sector. Despite the potential of its myostatin inhibitors, the company's P/E ratio stands at -5.39, indicating that it is not currently profitable.
InvestingPro Tips reveal that while Scholar Rock has more cash than debt on its balance sheet, it is quickly burning through cash. This is a vital consideration for investors, as it may impact the company's ability to sustain long-term research and development efforts. Additionally, analysts have revised their earnings downwards for the upcoming period, which could signal caution regarding the company's near-term financial outlook.
Moreover, the company's stock has experienced a significant decline over the last week, with a one-week price total return of -12.61%. This volatility may be a point of concern for investors, although it's worth noting that the company has seen a high return over the last year, with a one-year price total return of 63.82%. These metrics suggest that while the company faces challenges, there is a potential upside that investors may want to consider.
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