BOSTON, Massachusetts — August 4, 2026 — Leads & Copy — CervoMed Inc., a clinical-stage biotechnology company focused on developing treatments for age-related brain disorders, announced today that its investigational drug candidate, neflamapimod, has received an Innovation Passport designation to enter the UK’s Innovative Medicines and Health Products Regulatory Agency (MHRA) Accelerated Access Pathway (ILAP) for the development of neflamapimod in dementia with Lewy bodies (DLB).
The ILAP program is designed to expedite the time to market and improve patient access to innovative new medicines in the UK that address significant unmet clinical needs. Neflamapimod was selected for the ILAP through a joint consensus, recognized for its potential as an innovative therapy for DLB, a condition with a high unmet need and the demonstrated potential to offer a major therapeutic advantage.
This designation provides CervoMed with early and coordinated guidance from key UK regulatory and health bodies, including the MHRA, the National Health System (NHS), and health technology assessment (HTA) bodies such as 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.
“We are 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.”
Dementia with Lewy bodies (DLB) is the second most common progressive dementia in older people in the UK, yet it remains poorly understood and is often misdiagnosed. Jacqui Cannon, Chief Executive of the Lewy Body Society, commented, “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.”
Neflamapimod is an investigational, orally administered small-molecule drug that targets neuroinflammation-driven disease processes underlying degenerative disorders of the brain. It selectively inhibits the alpha isoform of p38 MAP kinase, a key driver of neuroinflammation and synaptic dysfunction. Neflamapimod readily crosses the blood-brain barrier and has shown potential to reverse synaptic dysfunction, improve neuron health, and slow or prevent disease progression.
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 Phase 2a AscenD-LB trial, neflamapimod significantly improved dementia severity and functional mobility in patients with DLB. Results from the Phase 2b RewinD-LB trial further supported neflamapimod’s potential to deliver meaningful clinical benefit, improving both cognitive and functional outcomes and showing positive effects on key markers of neurodegeneration.
CervoMed is focused on developing treatments for age-related brain disorders. The company has obtained alignment with the FDA and global regulatory authorities on a potential registration path for neflamapimod in DLB and is currently seeking a strategic partner to advance the drug into a Phase 3 trial. CervoMed is also evaluating neflamapimod in other neurological conditions, including nfvPPA and amyotrophic lateral sclerosis (ALS).
Source: CervoMed Inc.
