INmune Bio Inc. (NASDAQ: INMB) announced it has received official written alignment from the UK Medicines and Healthcare products Regulatory Agency (MHRA) following a May 12 pre-Marketing Authorization Application (pre-MAA) scientific advice meeting for its Ebstrocel cell therapy in Recessive Dystrophic Epidermolysis Bullosa (RDEB).

The MHRA confirmed agreement across all questions submitted by INmune Bio covering chemistry, manufacturing and controls (CMC), non-clinical, and clinical evidence packages. The company said the alignment supports its planned 2026 UK Conditional Marketing Authorization Application for Ebstrocel, the RDEB-specific formulation derived from its CORDStrom cell platform.

In written pediatric feedback, the MHRA recognized data from INmune Bio's MissionEB Phase 2 trial as demonstrating "clinically meaningful symptomatic benefit, particularly in pain and pruritus," and stated the data "could support the positioning as chronic or intermittent supportive therapy for RDEB." The agency also noted the study did not show durable wound closure or sustained reduction in total wound burden after treatment stopped, calling that "a significant limitation."

The MHRA advised INmune Bio to broaden its planned pediatric age range to zero to 18 years and shift endpoint focus away from wound closure. The agency also indicated openness to Bayesian statistical models and patient- and parent-reported outcome data, given the small patient populations typical of ultra-rare diseases.

"MHRA's comments recognize the patient-relevant symptomatic benefits observed in MissionEB and provide specific guidance on the evidence package, manufacturing transition and confirmatory trial design needed to support review," said Chief Executive Officer David Moss.

INmune Bio said it is incorporating the MHRA's endpoint recommendations into a confirmatory Phase 3 program, which is expected to open in 2026. The company also plans to submit a Marketing Authorization Application to the European Medicines Agency and a Biologics License Application to the U.S. Food and Drug Administration, with additional filings targeted for late 2026 or early 2027.