The biotech is taking a synergistic approach to obesity with two muscle-preserving antibodies set to enter a Phase II study in mid-2024 in combination with existing incretin-based treatments.
Pictured: A muscle pattern dissolving/Nicole Bean for BioSpace
Regeneron is gearing up to jump into the highly lucrative obesity market with a Phase II trial for its muscle-conserving antibodies slated for the middle of 2024, the company revealed Friday during its fourth-quarter and full-year 2023 earnings presentation.
“Despite all the enthusiasm surrounding GLP-1 agonist for obesity, it has been increasingly recognized that the profound weight loss is accompanied by substantial muscle loss accounting for up to as much as 40% of the weight loss,” Regeneron CEO George Yancopoulos said during Friday’s call with investors.
Yancopoulos called the risk of muscle atrophy “potentially irretrievable” and “catastrophic,” with the possibility of triggering “major public health concerns in the future.”
While Regeneron will be up against market leaders Novo Nordisk and Eli Lilly in the obesity space, its approach is more an attempt at synergy than direct competition. The New York-based pharma is developing two monoclonal antibodies—trevogrumab and garetosmab—which it aims to test in combination with incretin-based therapies, such as semaglutide and tirzepatide.
Trevogrumab targets and inhibits myostatin which is a negative regulator of skeletal muscle, while garetosmab binds to activin A, also a key player in muscle deterioration. By blocking both pathways, Regeneron’s antibodies could potentially boost the quality of weight loss in patients by preserving lean muscle in patients taking GLP-1 receptor agonists, according to the company’s presentation.
Regeneron expects to start enrolling obese patients in the Phase II study in mid-2024, pending findings from a safety and tolerability study of high-dose trevogrumab in healthy volunteers.
Both Novo and Lilly have also begun to try to address muscle atrophy in their already-dominant obesity franchises. In July 2023, Lilly bought Versanis for $1.925 billion gaining access to bimagrumab, which also blocks the activin and myostatin cascades to preserve muscle mass during weight loss.
Novo dropped $255 million in January 2024 to license from Swiss biotech EraCal Therapeutics an oral pill designed to suppress appetite and control body weight.
Regeneron reported total revenue of $3.43 billion in the fourth quarter of 2023, representing a slight 1% improvement from the same period the prior year. Full-year revenues, however, jumped 8% from $12.17 billion in 2022 to $13.12 billion in 2023.
Much of the slowdown in the fourth quarter was attributed to Regeneron’s COVID-19 drug Ronapreve (casirivimab/imdevimab). In the quarter, Regeneron only received $2.1 million gross profit payments from Roche in connection with Ronapreve sales, compared to $396.4 million during the same period in 2022.
Regeneron’s fourth-quarter results and obesity plans come shortly after it announced that it had acquired full development and commercialization rights to 2seventy bio’s pipeline of immune cell therapies, including the biotech’s discovery and manufacturing facilities. Regeneron will fold these acquired assets into a new R&D unit—Regeneron Cell Medicines—focused on oncology and immunology.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
