INmune Bio Files MHRA Pre-Submission Package for CORDStrom Program
INmune Bio submitted a pre-submission package to the UK MHRA for its lead candidate CORDStrom, marking the first formal engagement ahead of a regulatory filing. The package incorporates available safety, pharmacokinetics and preclinical efficacy data to support protocol design for upcoming clinical trials in the UK.
1. Submission Details
On February 11, 2026, INmune Bio formally submitted a detailed pre-submission package to the UK Medicines and Healthcare products Regulatory Agency for its CORDStrom candidate. The dossier outlines safety profiles, pharmacokinetic results and key preclinical efficacy findings to inform regulatory expectations ahead of a full marketing authorization application.
2. CORDStrom Program Overview
CORDStrom is INmune Bio’s lead therapeutic asset, designed to modulate innate immune pathways for treatment of severe inflammatory disorders. Initial Phase I studies demonstrated a favorable safety and tolerability profile, while preclinical models showed dose-dependent efficacy signals that underpin the package’s clinical protocol recommendations.
3. Next Steps and Timeline
MHRA typically issues feedback requests or meeting invitations within 30 days of submission. INmune Bio plans a scientific advice meeting by Q2 2026, with the aim of finalizing its UK clinical trial protocol and filing a Clinical Trial Application by mid-2026.