MartinLutherKing
5 days ago
Elevai Biosciences, a Subsidiary of Elevai Labs Inc., Engages Leading Contract Research Organization (CRO) to Support Regulatory Planning Efforts and Pre-IND Meeting with the Food and Drug Administration For EL-22 For The Treatment of Obesity
NEWPORT BEACH, Calif., Oct. 22, 2024 (GLOBE NEWSWIRE) --
EL-22 is a novel myostatin asset for the potential treatment of obesity in combination with existing GLP-1 medicines
The Investigational New Drug application is planned for submission to the U.S. Food and Drug Administration (โFDAโ) in 2025
Muscle wasting is a common side effect of popular GLP-1 weight-loss medications, with no current approved treatments. EL-22 may offer an importation solution by preserving muscle mass while reducing fat mass
Elevai Biosciences Inc. (โElevai Biosciencesโ), a subsidiary of Elevai Labs Inc. (NASDAQ: ELAB) (the โCompanyโ or โElevaiโ), today announced that it has engaged KCRN Research, Inc., a global contract research organization (CRO), to support the Companyโs initial efforts to prepare for an Investigational New Drug (โINDโ) application to the FDA for EL-22 in the treatment of obesity and muscle loss preservation.
KCRN specializes in bridging the regulatory gap for Korean-originated assets like EL-22 and preparing early phase drug development projects for the FDA. The Company and CRO partner KCRN are gathering the development work required for the IND submission, including preparing and scheduling a pre-IND meeting with the FDA to determine the path forward for EL-22. The Company intends to complete an IND submission in 2025 and to initiate clinical trials in the U.S. to evaluate the myostatin approach in combination with one or more GLP-1 receptor agonists in obesity.
โMyostatin is currently being pursued as a leading approach for muscle preservation in clinical trials with GLP-1 medications,โ said Deniel Mero, Co-founder of Elevai Biosciences. โWe are excited by this validated pathway and look forward to KCRNโs support in preparing EL-22 for IND submission. We think this collaboration is the first step to preparing EL-22 for eventual clinical trials and KCRNโs familiarity and experience with both the FDA and our asset make them an ideal CRO partner.โ
EL-22, an engineered probiotic expressing myostatin on its surface, targets a clinically validated myostatin pathway that plays an important role in regulating muscle. Preclinical results of EL-22 from a 2022 study demonstrated physiological (serum creatine kinase level), physical (body weight change), and functional (rotarod test) improvements in the dystrophic features of mdx mice, a mouse model of Duchenne muscular dystrophy (DMD)1. The Company believes that EL-22 offers a differentiated, oral approach as compared to other injection myostatin strategies being tested in obesity. It is believed that the mechanism of EL-22 induces mucosal immunity through the bodyโs own anti-myostatin antibodies and has the potential to treat obesity in combination with popular weight loss therapeutics, including GLP-1 receptor agonists, by preserving muscle mass while decreasing fat mass.
โWe are delighted in our continued support of Elevai and their myostatin program,โ said Hugh Lee, CEO & Founder of KCRN. โWe are hopeful that this work may result in a new treatment option for the millions of GLP-1 patients in need of a way to preserve muscle.โ