EL-22 / MOA Life Plus, PMGC Holdings - LARVOL DELTA

Northstrive Biosciences Strengthens IP Portfolio with New US Patent Filings for EL-22 and EL-32 Programs Covering Obesity and Animal Health (GlobeNewswire) - "These patent applications cover the animal market, as well as treating muscle loss in obese patients, both as standalone and combination therapies alongside GLP-1 receptor agonists. The Company filed the following four patents today: (i) EL-22 in Animals: Fusion Protein of Myo-2 for Use in Encouraging Muscle Growth in Animals (Patent Application No. 19/191,246); (ii) EL-32 in Obesity as Monotherapy and Combination with GLP-1: Updated patent filings for Pharmaceutical Composition for Treatment of Muscle Loss Due to Obesity Treatments (Patent Application No. 19/191,209), and Combination Therapy for Treatment of Muscle Loss Due to Obesity Treatments utilizing GLP-1 receptor agonists (Patent Application No. 19/191,226); (iii) EL-32 in Animals: Animal Feed Additive to Encourage Muscle Growth (Patent Application No. 19/191,258)."

Patent • Obesity

Northstrive Biosciences Announces Positive FDA Response Supporting A Submission of IND for a Phase 2 Clinical Trial for EL-22 in Combination with GLP-1 Receptor Agonist for Obesity Treatment (GlobeNewswire) - "Northstrive Biosciences..announced that it has received preliminary responses and commentary from the U.S. Food and Drug Administration ('FDA') regarding its scheduled Type B pre-Investigational New Drug ('pre-IND') meeting....The FDA’s responses indicated, amongst other things, that it agreed that (i) Northstrive’s pharmacology studies support EL-22 activity; (ii) Northstrive’s nonclinical studies appear adequate to support the safety and activity of EL-22 in overweight and obese human populations, and (iii) data from Northstrive’s Phase 1 study and completed nonclinical studies appear adequate to allow the initiation of the proposed Phase 2 clinical trial. Northstrive believes the FDA’s preliminary responses regarding the pre-IND meeting were sufficient and will forego the pre-IND meeting. Northstrive aims to file the Investigational New Drug application in 2025 and thereafter initiate a Phase 2 clinical trial..."

FDA event • IND • New P2 trial • Obesity

Northstrive Biosciences Inc. Schedules Pre-IND Meeting with FDA for EL-22, an Obesity Therapy Targeting Fat Loss and Muscle Preservation in Combination with GLP-1 (GlobeNewswire) - "Northstrive Biosciences Inc....announced that it has scheduled a pre-Investigational New Drug ('pre-IND') meeting with the U.S. Food and Drug Administration ('FDA') for Wednesday, April 23, 2025. Northstrive will have a Type B pre-IND meeting with the FDA to discuss the path forward for filing an IND for EL-22 as a combination treatment with GLP-1 for muscle preservation."

FDA event • Obesity

EL-22: Preparing for FDA Pre-IND Meeting Request (GlobeNewswire) - "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....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."

FDA event • IND • Obesity

Elevai Biosciences, a Subsidiary of Elevai Labs Inc., Announces FDA Regulatory Pathway for EL-22, a Pioneering Obesity Therapy Targeting Fat Loss and Muscle Preservation (GlobeNewswire) - "Elevai Labs Inc...a diversified holding company, subsidiary Elevai Biosciences Inc...today announced the next steps in its regulatory strategy for EL-22, aimed at treating obesity and preserving muscle mass. In collaboration with KCRN Research, Inc., the Company is preparing for a pre-IND meeting with the FDA, anticipated in the first quarter of 2025. This meeting will establish the development pathway for EL-22, clarifying any additional preclinical requirements and adjustments to Chemistry, Manufacturing, and Controls before IND submission....Elevai aims to file the IND in 2025 and thereafter initiate clinical trials to evaluate the combination of EL-22 with GLP-1 receptor agonists for obesity treatment."

FDA event • IND • Metabolic Disorders • Obesity

A New Method of Myostatin Inhibition in Mice via Oral Administration of Lactobacillus casei Expressing Modified Myostatin Protein, BLS-M22. (PubMed, Int J Mol Sci) - "Myostatin blockade resulted in serological, histological, and functional improvements in mdx mice. Overall, the findings suggest the potential of BLS-M22 to treat DMD; however, further clinical trials are essential to ascertain its efficacy and safety in humans."

Journal • Preclinical • Duchenne Muscular Dystrophy • Fibrosis • Genetic Disorders • Immunology • Muscular Dystrophy

Safety Study of BLS-M22 in Healthy Volunteers (clinicaltrials.gov) - P1; N=37; Completed; Sponsor: BioLeaders Corporation; Recruiting ➔ Completed; Trial completion date: Aug 2020 ➔ Nov 2020

Clinical • Trial completion • Trial completion date • Duchenne Muscular Dystrophy • Muscular Dystrophy

Bioleaders “Discussing a new drug platform and ’BLS-M22’ LO at JP Morgan Healthcare” [Google translation] (iN THE NEWS Corp) - "...Bioleaders (CEO Young-cheol Park)...had discussed licensing out its new drug platform and new drug candidate 'BLS-M22' at the '2021 JP Morgan Healthcare Conference'. It is currently under a confidentiality agreement (CDA) and plans to go through the procedure for subsequent license out after signing....As new drugs can be released if the phase 2 clinical trial is completed, discussions on future clinical development plans and joint research and development in the United States and other countries have focused."

Licensing / partnership • Duchenne Muscular Dystrophy

Bioleaders completes Phase 1 clinical trial of’BLS-M22’, a drug for Duchenne disease, a rare childhood [Google translation] (MBN) - "Bioleaders...has completed a domestic phase 1 clinical trial of a new drug candidate'BLS-M22', which is being developed as an indication for the treatment of Duchenne disease, a rare childhood disease. The BLS-M22 Phase 1 clinical trial conducted at Seoul Samsung Hospital was conducted to evaluate the safety of healthy individuals...we are looking forward to the possibility of conditional approval after the end of phase 2 we will try to speed up the commercialization of the product."

Regulatory • Trial completion • Duchenne Muscular Dystrophy

[Business tour] Bioleaders 'Ciline cruising… 'New corona vaccine development efforts' [Google Translation] (E-Today) - "'The Phase 1 clinical trial of 'BLS-M22', a rare muscle disease...will be completed around March ~ April this year. We will announce the clinical results of two new drug pipelines in July.'"

P1 data • Trial status

Safety Study of BLS-M22 in Healthy Volunteers (clinicaltrials.gov) - P1; N=37; Recruiting; Sponsor: BioLeaders Corporation; Not yet recruiting ➔ Recruiting; Trial completion date: Dec 2019 ➔ Aug 2020; Trial primary completion date: Oct 2019 ➔ Jun 2020

Clinical • Enrollment open • Trial completion date • Trial primary completion date