INmune Bio receives MHRA pediatric plan approval for Ebstrocel

INmune Bio Inc. (NASDAQ: INMB) announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved the Pediatric Investigation Plan (PIP) for Ebstrocel, the company's treatment candidate for Recessive Dystrophic Epidermolysis Bullosa (RDEB), a rare and severe skin disease.

The PIP approval is a required first step toward a Marketing Authorization Application (MAA) submission in the United Kingdom. The company stated the milestone aligns with its plan to file an MAA with the MHRA in 2026 and a US filing for Accelerated Approval in early 2027.

The MHRA completed its review in under three months, compared to the standard ten-month review cycle. The company had requested an accelerated review citing unmet medical need in RDEB. According to INmune Bio, the MHRA raised no objections to the clinical data or the claims presented in the submission.

"The MHRA's turnaround in under three months represents a clear endorsement of the clinical data package," said Dr. Mark Lowdell, Chief Scientific Officer of INmune Bio. "Their constructive advice on minor adjustments to the phase 3 open-label trial protocol has already been integrated."

Approximately 300 children in the United Kingdom are affected by RDEB, part of a broader epidermolysis bullosa community of at least 5,000 individuals. The PIP submission establishes the scientific justification for treating children with RDEB, citing chronic wounds, intractable itch, and severe pain as primary symptoms.

Ebstrocel is part of INmune Bio's CORDStrom platform, which uses pooled, allogeneic, human umbilical cord-derived mesenchymal stromal cells. The company said it is now focused on final preparations for the MAA submission and completing commercial manufacturing steps required for Ebstrocel authorization.

According to the company's statement, the MHRA also provided written alignment across chemistry, manufacturing and controls, non-clinical, and clinical strategy elements ahead of the planned MAA filing.

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