Elevai Biosciences: Charting a Course for Obesity Treatment with EL-22
Tuesday, Oct 22, 2024 10:01 am ET
1min read Elevai Biosciences, a subsidiary of Elevai Labs Inc., has taken a significant step towards addressing the global obesity epidemic by engaging KCRN Research, Inc., a leading contract research organization (CRO), to support regulatory planning efforts and a pre-IND meeting with the Food and Drug Administration (FDA) for EL-22, a novel myostatin asset for the potential treatment of obesity.
Obesity is a pressing global health concern, with muscle wasting being a common side effect of popular GLP-1 weight-loss medications. EL-22, an engineered probiotic expressing myostatin on its surface, targets the clinically validated myostatin pathway that plays an important role in regulating muscle. Preclinical results from a 2022 study demonstrated physiological, physical, and functional improvements in the dystrophic features of mdx mice, a mouse model of Duchenne muscular dystrophy (DMD).
KCRN Research, with its extensive experience in bridging the regulatory gap for Korean-originated assets and preparing early phase drug development projects for the FDA, will provide invaluable support to Elevai Biosciences in navigating the complex regulatory landscape. 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. This collaboration is a significant milestone in the development of EL-22 and underscores Elevai Biosciences' commitment to addressing the unmet medical needs of obesity patients.
Elevai Biosciences believes that EL-22 offers a differentiated, oral approach compared to other injection myostatin strategies being tested in obesity. The mechanism of EL-22 induces mucosal immunity through the body's own anti-myostatin antibodies, potentially treating obesity in combination with popular weight loss therapeutics, including GLP-1 receptor agonists, by preserving muscle mass while decreasing fat mass.
In conclusion, Elevai Biosciences' engagement of KCRN Research, Inc. marks a crucial step in the development and regulatory planning of EL-22, a promising novel myostatin asset for the potential treatment of obesity. With the support of KCRN's expertise and experience, Elevai Biosciences is well-positioned to navigate the regulatory landscape and bring EL-22 to clinical trials, ultimately aiming to address the unmet medical needs of obesity patients.
Obesity is a pressing global health concern, with muscle wasting being a common side effect of popular GLP-1 weight-loss medications. EL-22, an engineered probiotic expressing myostatin on its surface, targets the clinically validated myostatin pathway that plays an important role in regulating muscle. Preclinical results from a 2022 study demonstrated physiological, physical, and functional improvements in the dystrophic features of mdx mice, a mouse model of Duchenne muscular dystrophy (DMD).
KCRN Research, with its extensive experience in bridging the regulatory gap for Korean-originated assets and preparing early phase drug development projects for the FDA, will provide invaluable support to Elevai Biosciences in navigating the complex regulatory landscape. 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. This collaboration is a significant milestone in the development of EL-22 and underscores Elevai Biosciences' commitment to addressing the unmet medical needs of obesity patients.
Elevai Biosciences believes that EL-22 offers a differentiated, oral approach compared to other injection myostatin strategies being tested in obesity. The mechanism of EL-22 induces mucosal immunity through the body's own anti-myostatin antibodies, potentially treating obesity in combination with popular weight loss therapeutics, including GLP-1 receptor agonists, by preserving muscle mass while decreasing fat mass.
In conclusion, Elevai Biosciences' engagement of KCRN Research, Inc. marks a crucial step in the development and regulatory planning of EL-22, a promising novel myostatin asset for the potential treatment of obesity. With the support of KCRN's expertise and experience, Elevai Biosciences is well-positioned to navigate the regulatory landscape and bring EL-22 to clinical trials, ultimately aiming to address the unmet medical needs of obesity patients.
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