ELEVAI LABS, inc. announced that it has entered into an exclusive licensing agreement with MOA Life Plus Co., Ltd., (“MOA”) a South Korean corporation, with the aim to develop and commercialize two novel assets for the treatment of obesity and muscle loss prevention.
The licensed assets include EL-22, a clinical stage engineered probiotic expressing myostatin, and EL-32, a preclinical engineered probiotic expressing dual myostatin & activin-A. EL-22 has completed a Phase 1 clinical trial in South Korea, demonstrating it was generally well tolerated and safe in healthy volunteers. Elevai intends to evaluate EL-22 for efficacy and safety in combination with popular weight-loss therapeutics currently on the market, with the goal of decreasing fat mass while preventing the muscle wasting that commonly occurs with weight-loss drugs.
“This license agreement represents a transformational and strategic milestone for Elevai,” said Jordan R. Plews, PhD, Co-Founder and Chief Executive Officer of the Company. “The adoption and use of other GLP-1 drugs has resulted in rapid weight loss and increases the desire for related aesthetic procedures linked to the side effects from these drugs, including significant unwanted muscle loss. We see the licensing of these two assets as an opportunity to provide an unmet need and expand into a large and growing multi-billion-dollar market.”
According to the CDC, 42% of adults suffer from obesity and could benefit from weight loss medication. Approved popular GLP-1 drugs such as Ozempic® (semaglutide), Wegovy® (semaglutide) or Mounjaro® (tirzepatide) are expected to lead the anti-obesity market to $100 billion by 2030, according to Goldman Sachs Research. However, there remains a significant challenge as weight loss from the approved GLP-1 medications also results in collective loss of fat mass and lean muscle mass, which is critical for metabolism, strength, and mobility.
Based on preclinical data, Elevai believes that the assets it has licensed have the potential to significantly improve the standard of care for the treatment of obesity in combination with GLP-1 by preserving muscle mass while decreasing fat mass. The Company plans to make an IND submission in 2025 and to initiate clinical trials in the U.S. to evaluate the probiotic approach of EL-22 and EL-32 in combination with one or more GLP-1 receptor agonists in obesity.
“Myostatin is a clinically validated target that has demonstrated potential in muscle mass and strength building and is currently being tested in combination with GLP-1 weight loss drugs,” said Dr. Tim Sayed, Chief Medical Officer of Elevai. “With our new additions, we believe that we have a differentiated, oral approach as compared to other myostatin strategies being tested in obesity. Our approach induces mucosal immunity through the body’s own anti-myostatin antibodies, which could have an important role in addressing the unmet medical need of obese patients, who need to preserve muscle while losing weight.”
Under the terms of the license agreement, the Company obtained global rights outside of South Korea to develop and commercialize the assets in exchange for upfront cash and equity consideration. MOA is also eligible to receive milestone payments based upon the achievement of certain of the Company’s development and sales milestones, and royalties on net sales of certain royalty-bearing products sold by Elevai and its affiliates or sublicensees.
