CATUG Biotechnology Supports BodMed's Positive Clinical Progress with BMD003, a First-in-Class non-LNP, non-Viral Inhaled mRNA Freeze-Dried Formulation
November 13 , 2024

BodMed, an innovative biotechnology company specializing in "Mucosal RNA Medicines," recently announced positive interim data from an investigator-initiated trial (IIT) led by Peking Union Medical College Hospital. The trial evaluates BMD003, a first-in-class non-lipid nanoparticle (non-LNP), non-viral inhaled mRNA freeze-dried formulation, developed on BodMed's proprietary MucoRD® mucosal delivery platform. As the CRDMO partner for this program, CATUG Biotechnology extends its warm congratulations to BodMed on this milestone.

 

The study assesses safety, tolerability, pharmacokinetics, and preliminary efficacy of nebulized BMD003 in adult patients with cystic fibrosis (CF). In the single ascending dose (SAD) phase, subjects in all three dose groups demonstrated favorable safety and tolerability, with no drug-related adverse events. Follow-up data indicated clinically meaningful lung function improvement (ppFEV1). The pharmacokinetic profile supports a potential weekly (QW) or biweekly (Q2W) dosing regimen, which could significantly improve patient compliance.

 

This achievement stems from BodMed's groundbreaking scientific R&D and successful translation from bench to bedside. CATUG Biotechnology supported the BMD003 program by providing GMP manufacturing facilities and testing services for IIT samples, including: · Providing GMP-compliant production site for clinical batches;

we ensure clinical supply and quality consistency through mature formulation processes and GMP standards, steadily advancing our partners' scientific achievements to the clinical stage."

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