CervoMed Inc. (NASDAQ: CRVO) announced that its drug candidate neflamapimod has been granted an Innovation Passport under the UK's Innovative Licensing and Access Pathway (ILAP) for the treatment of dementia with Lewy bodies (DLB).

The designation provides CervoMed with coordinated guidance from the UK Medicines and Healthcare products Regulatory Agency (MHRA), the National Health Service (NHS), and health technology assessment bodies including the National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC), the All Wales Therapeutics and Toxicology Centre (AWTTC), and the Department of Health Northern Ireland.

The company said the ILAP entry criteria were revised in early 2025, raising the scientific threshold required to receive the designation.

"Very few drugs have been granted this opportunity through the ILAP since the entry criteria into the program were revised and the scientific hurdle for receiving the designation was increased in early 2025," said Dr. Mark De Rosch, Executive Vice President, Regulatory and Government Affairs, and Program Management at CervoMed.

Neflamapimod is an oral small-molecule drug that selectively inhibits the alpha isoform of p38 MAP kinase. Across Phase 1 and 2 trials involving more than 800 participants, the drug has been generally well tolerated. In the 91-patient Phase 2a AscenD-LB trial, neflamapimod showed improvement in dementia severity and functional mobility. Results from the 159-patient Phase 2b RewinD-LB trial showed improvement in cognitive and functional outcomes.

There are currently no approved treatments for DLB in the United States or the European Union. DLB is described as the second most common progressive dementia after Alzheimer's disease.

CervoMed stated it is currently seeking a strategic partner to advance neflamapimod into a Phase 3 trial in DLB. The company also expects interim biomarker data from its ongoing Phase 2a trial in primary progressive aphasia in early fourth quarter of 2026, and anticipates dosing the first patient in the EXPERTS-ALS Phase 2a trial in the fourth quarter of 2026.