Northstrive Biosciences is advancing obesity treatments EL-22 and EL-32, focusing on muscle preservation during weight loss therapies.
Quiver AI Summary
Northstrive Biosciences Inc. is advancing its obesity treatment candidates EL-22 and EL-32, which utilize a myostatin-engineered probiotic approach to maintain muscle mass during weight loss therapies, including GLP-1 receptor agonists. The company is preparing for a pre-Investigational New Drug meeting with the U.S. FDA and plans to file an Investigational New Drug application for EL-22 in 2025, following successful preclinical and clinical results in South Korea. Additionally, Northstrive has engaged a contract research organization to conduct preclinical studies on EL-32, which targets myostatin and activin-A for improved muscle regulation and will be assessed for efficacy in combination with semaglutide, a GLP-1 receptor agonist. The company aims to present its findings at the upcoming UCLA Obesity Symposium.
Potential Positives
- Northstrive is preparing for a pre-Investigational New Drug meeting with the FDA, indicating progress towards regulatory approval for its lead asset EL-22, which addresses obesity while preserving muscle mass.
- EL-22 has completed a Phase 1 clinical trial in South Korea, demonstrating safety and general tolerability, which enhances its credibility in the market.
- The company has engaged a leading contract research organization to support preclinical studies for EL-32, which diversifies its research efforts in obesity treatment.
- Northstrive will present its innovative obesity drug candidates at a prestigious UCLA Symposium, raising its visibility in the scientific and medical communities.
Potential Negatives
- Northstrive is still in the preparation stages for a pre-Investigational New Drug meeting with the FDA, which indicates that they have not yet secured approval for clinical trials, potentially delaying product rollout.
- The heavy reliance on data from a South Korean licensing partner raises concerns regarding the robustness and independence of their research findings, which could affect credibility.
- Forward-looking statements highlight uncertainties and risks, including the potential for actual results to differ materially from anticipated outcomes, which may undermine investor confidence.
FAQ
What is Northstrive Biosciences Inc. focused on?
Northstrive Biosciences Inc. concentrates on developing innovative treatments for obesity while preserving muscle mass during weight loss therapies.
What is the significance of the EL-22 probiotic?
EL-22 is an engineered probiotic designed to express myostatin, aimed at supporting muscle health during weight loss treatments.
When does Northstrive expect to meet with the FDA?
Northstrive anticipates a Type B pre-IND meeting with the FDA in the second quarter of 2025.
What does the research on EL-32 involve?
The research on EL-32 will evaluate its effectiveness in combination with GLP-1 receptor agonist semaglutide for glycemic control.
Where will Northstrive present its obesity treatment candidates?
Northstrive will present its obesity drug candidates at the UCLA Obesity Symposium on February 7, 2025.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$ELAB Hedge Fund Activity
We have seen 7 institutional investors add shares of $ELAB stock to their portfolio, and 4 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- SABBY MANAGEMENT, LLC added 2,541,779 shares (+inf%) to their portfolio in Q3 2024, for an estimated $210,967
- WHITTIER TRUST CO OF NEVADA INC removed 80,666 shares (-100.0%) from their portfolio in Q3 2024, for an estimated $6,695
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- TWO SIGMA SECURITIES, LLC added 43,265 shares (+inf%) to their portfolio in Q3 2024, for an estimated $3,590
- TOWER RESEARCH CAPITAL LLC (TRC) added 39,128 shares (+inf%) to their portfolio in Q3 2024, for an estimated $3,247
- HRT FINANCIAL LP added 35,853 shares (+inf%) to their portfolio in Q3 2024, for an estimated $2,975
- DIVERSIFY ADVISORY SERVICES, LLC removed 25,000 shares (-100.0%) from their portfolio in Q4 2024, for an estimated $57,250
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Full Release
- Lead asset EL-22 is leveraging a myostatin-engineered probiotic approach to address obesity’s pressing issue of preserving muscle while on weight loss treatments, including GLP-1 receptor agonists.
- Northstrive Biosciences Inc. is preparing the necessary steps to leverage existing EL-22 animal data and human safety studies from Korean licensing partner to arrange an Investigational New Drug filing with the U.S. Food and Drug Administration.
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EL-32 is a pre-clinical, engineered probiotic expressing dual myostatin & activin-A, focusing on two clinically validated targets that play an important role in regulating muscle.
NEWPORT BEACH, Calif., Feb. 04, 2025 (GLOBE NEWSWIRE) -- Northstrive Biosciences Inc. ("Northstrive"), a subsidiary of PMGC Holdings Inc. (NASDAQ: ELAB) ("PMGC," "we," or "our"), announced an update for its innovative obesity treatment candidates, EL-22 and EL-32, both aimed at optimizing fat loss while preserving muscle mass in patients undergoing weight loss therapies, including GLP-1 receptor agonists.
EL-22: Preparing for FDA Pre-IND Meeting Request
Northstrive is finalizing preparations for a pre-Investigational New Drug ("pre-IND") meeting request with the U.S. Food and Drug Administration ("FDA"). Northstrive anticipates having a Type B pre-IND meeting with the FDA in the second quarter of 2025. Northstrive has completed necessary translations and compiled preclinical and clinical inquiries from existing data from its South Korean licensing partner to support the meeting request. Concurrently, Northstrive is seeking a U.S.-based Current Good Manufacturing Practices (cGMP) manufacturing partner for EL-22.
EL-22 is a novel, patent-pending engineered probiotic designed to express myostatin on its surface, targeting the validated myostatin pathway to support muscle health. Preclinical studies, including a 2022 publication in mdx mice (a model of Duchenne muscular dystrophy), demonstrated significant physiological and functional improvements. 1 EL-22 has also completed a Phase 1 clinical trial in South Korea, where it was shown to be generally well-tolerated and safe in healthy volunteers.
Upon regulatory confirmation, Northstrive aims to file the Investigational New Drug application in 2025 and thereafter initiate clinical trials to evaluate the combination of EL-22 with GLP-1 receptor agonists for obesity treatment.
EL-32: Engaged CRO for Preclinical Study
Northstrive has entered into a research agreement with a leading preclinical contract research organization (CRO) specializing in metabolic disorders. The research agreement will support a planned study to evaluate EL-32, an engineered probiotic expressing dual myostatin and activin-A inhibitors, both as a monotherapy and in combination with the GLP-1 receptor agonist semaglutide. The focus of the study will be on glycemic control and body composition in diet-induced obese (DIO) mice.
"We are laying the groundwork to move both programs forward as potential treatments for obesity," said Deniel Mero, Co-founder of Northstrive Biosciences. "The FDA has cleared other myostatin-based therapies to start clinical trials in combination with GLP-1 receptor agonists, which gives us confidence and a precedent to follow a similar path by leveraging existing data from our Korean licensing partner to accelerate our pre-IND process."
Upcoming Presentation
Northstrive will present its novel obesity drug candidates at the exclusive UCLA Obesity Symposium, "Anti-Obesity Treatments: Challenges and Emerging Solutions," organized by the UCLA Metabolism Theme, an initiative of the UCLA David Geffen School of Medicine. The presentation, titled "Myostatin-Engineered L. Casei Bacteria As A Muscle Preserving Therapeutic," is scheduled for Friday, February 7, 2025.
About Northstrive Biosciences
Northstrive Biosciences Inc., a PMGC Holdings Inc. company, is a biopharmaceutical company focusing on the development and acquisition of cutting-edge aesthetic medicines. Northstrive's lead asset, EL-22, is leveraging an engineered probiotic approach to address obesity’s pressing issue of preserving muscle while on weight loss treatments, including GLP-1 receptor agonists. For more information, please visit www.northstrivebio.com
About PMGC Holdings Inc.
PMGC Holdings Inc. is a diversified holding company that manages and grows its portfolio through strategic acquisitions, investments, and development across various industries. Currently, our portfolio consists of three wholly owned subsidiaries: Northstrive Biosciences Inc., PMGC Research Inc., and PMGC Capital LLC. We are committed to exploring opportunities in multiple sectors to maximize growth and value. For more information, please visit https://www.pmgcholdings.com .
Forward-Looking Statements
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. Forward-looking statements are made as of the date of this press release and are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy, activities of regulators and future regulations and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct, and the Company cautions investors that actual results may differ materially from the anticipated results. Therefore, you should not rely on any of these forward-looking statements. These and other risks are described more fully in PMGC Holdings’ filings with the United States Securities and Exchange Commission (“SEC”), including the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 29, 2024, and its other documents subsequently filed with or furnished to the SEC. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at www.sec.gov . All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
IR Contact:
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1 Reference: Sung DK, Kim H, Park SE, Lee J, Kim JA, Park YC, Jeon HB, Chang JW, Lee J. A New Method of Myostatin Inhibition in Mice via Oral Administration of Lactobacillus casei Expressing Modified Myostatin Protein, BLS-M22, Int. J. Mol. Sci. 2022 , 23, 9059. https://doi.org/10.3390/ijms23169059 .