CervoMed Announces Neflamapimod Awarded Innovation Passport Designation Under the UK Innovative Licensing and Access Pathway (ILAP) for Treatment of Dementia with Lewy Bodies (DLB)

CervoMed Announces Neflamapimod Awarded Innovation Passport --> Accessibility: Skip TopNav CervoMed Announces Neflamapimod Awarded Innovation Passport Designation Under the UK Innovative Licensing and Access Pathway (ILAP) for Treatment of Dementia with Lewy Bodies (DLB) August 04, 2026 05:15 ET | Source: Cervomed Cervomed Innovation Passport award designed to support accelerated time to market and help expedite patient access to potentially transformative new investigational medicines Neflamapimod selected for the ILAP by joint consensus — recognized for being an innovative therapy that addresses a condition of high unmet need, with the demonstrated potential to offer a major therapeutic advantage in DLB treatment Program provides CervoMed with early and coordinated guidance from the UK Medicines and Healthcare products Regulatory Agency (MHRA), the National Health System (NHS), and health technology assessment (HTA) bodies BOSTON, Aug. 04, 2026 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical-stage biotechnology company developing treatments for age-related brain disorders (CervoMed or the Company), today announced that neflamapimod, its oral, small molecule drug candidate targeting neuroinflammation-driven disease processes underlying degenerative disorders of the brain, has been granted an Innovation Passport to enter the UK’s ILAP for neflamapimod’s development in DLB. Focusing on potentially transformative investigational treatments that address unmet clinical needs, the ILAP is designed to accelerate time to market and facilitate patient access to new medicines in the UK. “We’re proud that neflamapimod has been granted entry into this unique and selective program, which recognizes both the highly significant need for an effective treatment for DLB and the transformative potential of neflamapimod for people with DLB and their families,” said Dr. Mark De Rosch, Ph.D., Executive Vice President, Regulatory and Government Affairs, and Program Management of CervoMed. “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. We look forward to working with the UK regulators, the HTA bodies, and all NHS partners as we prepare for our planned Phase 3 trial and work diligently to get neflamapimod to the patients who may benefit.” "DLB is the second most common progressive dementia in older people in the UK , yet it remains poorly understood and is often misdiagnosed. It is encouraging for the DLB community to see an investigational treatment for this devastating disease included in a program like ILAP. We are hopeful that the coordination between MHRA, the HTA bodies, and the NHS can bring us closer to patients having access to the UK's first approved treatment for DLB," said Jacqui Cannon, Chief Executive of the Lewy Body Society. The Innovation Passport designation provides access to a single integrated platform for sustained collaboration between biopharmaceutical companies and the ILAP Partners: the MHRA, NHS, the HTA bodies – 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. This includes priority access to services such as clinical trials support and NHS engagement, to help speed up access for patients where current treatment options are limited or non-existent. About Dementia with Lewy Bodies DLB is the second most common progressive dementia after AD, affecting millions worldwide. Patients may experience a combination of decline in cognitive function, cognitive fluctuations, visual hallucinations, and sleep disorders, as well as motor symptoms similar to Parkinson’s disease. There are no approved treatments for DLB in the United States or European Union, and the current standard-of-care therapies only temporarily relieve symptoms. About Neflamapimod Neflamapimod is an investigational, orally administered small-molecule drug that readily crosses the blood-brain barrier and selectively inhibits the alpha isoform of p38 MAP kinase, a key driver of neuroinflammation and synaptic dysfunction. By targeting the critical disease processes underlying degenerative disorders of the brain, neflamapimod has the potential to reverse synaptic dysfunction, improve neuron health, and slow or prevent disease progression. Neflamapimod is currently in clinical development for the treatment of DLB, recovery after ischemic stroke, and primary progressive aphasia. In nonclinical studies, neflamapimod restored synaptic function within the basal forebrain cholinergic system, the brain region most affected in DLB. Across Phase 1 and 2 clinical trials involving more than 800 participants, the drug has been generally well tolerated and demonstrated consistent signals of efficacy. In the 91-patient Phase 2a AscenD-LB