On August 18, PMGC Holdings (formerly Elevai Labs), a NASDAQ-listed U.S. company that entered into a technology transfer agreement worth a total of $131.06 million (approximately KRW 187.8 billion) with global healthcare company Moa Life Plus, announced that it will officially proceed with Phase 2 clinical trials of EL-22 in combination with a GLP-1 obesity treatment.
If the company proceeds with Phase 2 clinical trials this year in combination with a GLP-1-based obesity treatment, it will receive a milestone payment of $3 million, corresponding to the initiation of both Phase 1 and Phase 2 trials.
In April last year, Moa Life Plus transferred the technology for 'BLS-M22', a new drug candidate for Duchenne muscular dystrophy, to PMGC Holdings. 'BLS-M22' is a new drug candidate for muscle disease treatment based on a lactic acid bacteria platform technology that expresses myostatin, a protein antigen targeting diseases related to muscle loss. The company had previously completed Phase 1 clinical trials in Korea through its own research and development.
After Elevai Labs received the technology transfer for 'BLS-M22' from Moa Life Plus, it changed its name to PMGC Holdings at the end of last year and has since been conducting further research on 'BLS-M22' under the development name 'EL-22' through its subsidiary, Northstrive Biosciences Inc.
Northstrive Biosciences Inc. is pursuing the development of a treatment that can address muscle loss issues that may arise during weight loss therapies, such as GLP-1 receptor agonists, by utilizing a myostatin gene-modified lactic acid bacteria approach.
To advance clinical trials in the United States, Moa Life Plus discussed its research results with the U.S. Food and Drug Administration (FDA). As a result, the FDA concluded that the company’s non-clinical and Phase 1 clinical trial data are sufficient to proceed to Phase 2 clinical trials targeting overweight and obese individuals. Accordingly, Northstrive Biosciences Inc. plans to submit an Investigational New Drug (IND) application for Phase 2 clinical trials within this year and officially commence Phase 2 trials.
Additionally, in April of this year, Northstrive Biosciences Inc. filed a new U.S. patent application for both monotherapy and combination therapy with GLP-1 receptor agonists for the treatment of muscle loss in obese patients, thereby strengthening its pipeline and IP portfolio.
According to data from global market research firm Frost & Sullivan, sales of GLP-1 obesity treatments reached $6.2 billion (approximately KRW 8 trillion) last year, accounting for about 93% of the total obesity treatment market. The GLP-1 obesity treatment market is expected to grow at a steep compound annual growth rate of 48.4% over the next four years, reaching a market size of $48 billion (approximately KRW 65 trillion) by 2028.
A Moa Life Plus representative stated, "If Northstrive Bioscience Inc., which received the technology transfer for the Duchenne muscular dystrophy treatment 'BLS-M22', proceeds with Phase 2 clinical trials in combination with a GLP-1-based obesity treatment, it will receive a $3 million milestone payment for the initiation of Phases 1 and 2. This is expected to raise expectations for milestone revenues from further development and sales after Phase 2," adding, "The entire milestone payment received by our company will be recognized as revenue and profit, which is expected to have a positive effect on our financial structure as well as on the technology transfer of other pipelines."
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