- 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.
- Elevai believes that EL-22 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.
- Elevai plans to submit an Investigational New Drug (IND) application in 2025 that utilizes the licensed asset EL-22, previously called BLS-M221.
“With the growing prevalence of obesity, and popularity of drugs like Ozempic and Mounjaro, we believe there is a need for a treatment option that leads to weight loss without the associated loss of muscle. Based on the preclinical data generated by our licensor, we believe that EL-22 has the potential to treat obesity while supporting and preserving existing muscle,” said
Specifically, in the preclinical studies1:
- EL-22 showed a statistically significant increase in anti-myostatin IgG antibody concentration, where myostatin is a key negative regulator of muscle growth.
- Statistically significant decrease in creatine kinase levels, which indicates a decrease of muscle destruction.
- EL-22 administered to mdx mice, a mouse model of Duchenne muscular dystrophy, had improved physical activity and gross motor function, as demonstrated by a longer duration during rotarod tests.
Based on the highlighted preclinical data, Elevai believes that EL-22 has the potential to treat obesity in combination with GLP-1 by preserving muscle mass while decreasing fat mass. The Company intends to complete an IND submission in 2025 and to initiate clinical trials in the
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About Elevai Biosciences
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Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as “believes,” “expects,” “plans,” “potential,” “would” and “future” or similar expressions such as “look forward” are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning: Elevai’s expectations regarding its growth, strategy, progress and the design, objectives and timing of its clinical trials for EL-22; and the potential of EL-22 to treat obesity without an associated loss of muscle, both as a monotherapy and in combination with GLP-1 receptor agonists. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Elevai’s limited operating history and historical losses; Elevai’s ability to raise additional funding to complete the development and any commercialization of its product candidates; Elevai’s dependence on the success of its product candidates EL-22 and EL-32; that Elevai may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; Elevai’s ability to obtain, maintain and protect its intellectual property; and Elevai’s dependence on third parties in connection with manufacturing, clinical trials and preclinical studies.
These and other risks are described more fully in Elevai’s filings with the
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1 Reference: Sung DK, Kim H, Park SE, Lee J, Kim JA, Park YC, Jeon HB, Chang JW,
Source:
2024 GlobeNewswire, Inc., source