Moa Life Plus Accelerates U.S. Commercialization Process for Obesity Drug 'EL-22'... Local Clinical Development Gains Momentum

Moa Life Plus (142760) announced on August 5 that NorthStrive Biosciences, a subsidiary of its U.S. partner PMGC Holdings, has begun quantitative characterization and comparability assessments of the locally manufactured batch of the obesity therapeutic candidate substance 'EL-22,' following its technology transfer.

NorthStrive is progressing through sequential stages of manufacturing, analysis, and characterization, with the goal of entering Phase 2 clinical trials in the United States for EL-22. This comparability assessment is also part of the procedures to strengthen the development foundation for the submission of a Phase 2 Investigational New Drug (IND) application.

The company recently decided to launch an independent Fluorescence-Activated Cell Sorting (FACS) program to quantitatively confirm the expression levels of the target antigen for EL-22. The analysis will compare and assess the comparability of locally manufactured EL-22 in the U.S. with Moa Life Plus’s previously produced EL-22.

The analysis will focus on quantitatively measuring the target antigen expression levels on the surface of the lactic acid bacteria cells expressing EL-22 and identifying antigen expression characteristics at the individual cell level. Through this, the company plans to verify the identity of the product, consistency in the manufacturing process, and comparability with previously produced batches.

NorthStrive aims to further enhance product characterization and quality control systems for EL-22 through this assessment and to establish a foundation for upcoming IND submissions and clinical development in the U.S. To this end, specialized independent organizations will conduct antibody conjugation, cell viability and apoptosis analysis, sample testing, and quantitative data production.

Moa Life Plus expects that the establishment of the local manufacturing infrastructure in the U.S. is proceeding as planned and that global clinical development will gain further momentum.

A representative from Moa Life Plus said, “This comparability evaluation is a critical process to verify whether EL-22 produced in the U.S. secures product characteristics and manufacturing consistency identical to those of existing batches,” adding, “As our partner continues to sequentially build a local development and production system, we will continue to provide technical support and collaboration for the global clinical development of EL-22.”

This comparability assessment is considered a key step in validating the U.S. local manufacturing process for EL-22, ensuring manufacturing quality consistency, and expediting both Phase 2 clinical trials in the U.S. and the global commercialization process.

This content was produced with the assistance of AI translation services.