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CervoMed Inc., a clinical-stage biotechnology company developing treatments for age-related brain disorders (CervoMed or the Company), 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 dementia with Lewy bodies (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 programme, 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 programme 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.
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.
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 trial, neflamapimod significantly improved dementia severity and functional mobility in patients with DLB. Results from the 159-patient phase 2b RewinD-LB trial, a 16-week randomized, double-blind, placebo-controlled trial followed by a 32-week neflamapimod-only extension, 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, one by structural MRI and one a blood-based biomarker. Across both studies, the greatest benefits were observed in patients without AD co-pathology. Collectively, these findings underscore the therapeutic promise and scientific validity of neflamapimod as a potential treatment for DLB and other degenerative brain disorders.
The Lewy Body Society was the first Lewy body dementia charity in Europe.
The charity campaigns for greater recognition and resources for Lewy body dementia, funding cutting-edge research projects at leading universities across the UK to improve the diagnosis, treatment and care of people living with Lewy body dementia and their families.
It also provides information, advice and support to people affected by Lewy body dementia and their caregivers, as well as healthcare professionals and decision-makers.
CervoMed is a clinical-stage company developing treatments for age-related brain disorders. Its lead drug candidate, neflamapimod, is an oral small molecule targeting critical disease processes underlying degenerative disorders of the brain by inhibiting a key enzyme involved in neuroinflammation and neurodegeneration.
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