CervoMed (NASDAQ:CRVO) is positioning its lead candidate, neflamapimod, as a targeted treatment for dementia with Lewy bodies, or DLB, while advancing additional clinical programs in a subtype of frontotemporal dementia and amyotrophic lateral sclerosis.
Speaking at a Canaccord Genuity conference, Chief Executive Officer John Alam said the Boston-based biotechnology company has made substantial progress during the first half of the year, including becoming “phase III-ready” in DLB and advancing a study in non-fluent variant primary progressive aphasia, or nf-vPPA.
DLB program centers on inflammation biology
He also cited a July paper in Neuron that, according to Alam, identified interleukin-6 and interleukin-1 beta signaling as key mechanisms associated with symptoms and disease progression in DLB. Neflamapimod is designed to block interleukin-1 beta signaling and affect interleukin-6 production and other downstream inflammatory factors, he said.
The company presented data at the ADPD conference in April showing that neflamapimod was a potent blocker of interleukin-1 beta signaling and that this effect translated into lower interleukin-6 levels in cerebrospinal fluid, Alam said.
Phase IIb results and MRI findings
Alam highlighted additional analyses from CervoMed’s Phase IIb DLB trial, including results from patients characterized as having “pure” DLB rather than DLB with coexisting Alzheimer’s disease pathology. In the placebo-controlled period, a lower-exposure capsule batch produced a 0.7-point improvement in Clinical Dementia Rating Sum of Boxes, or CDR-SB, according to Alam.
He said the analysis had a P value of 0.054 and involved roughly 45 to 48 patients. CervoMed views a 0.5-point change in CDR-SB as clinically meaningful, he said. Higher blood concentrations of neflamapimod were associated with a greater treatment effect in the company’s analyses.
Alam also discussed an MRI substudy conducted among participants in the United Kingdom and the Netherlands. The data included a small number of patients, but he described the results as compelling. In the placebo-controlled period, the neflamapimod group showed a 3.5% increase in basal forebrain volume, while placebo-treated participants experienced declining volume.
According to Alam, placebo patients who later moved onto neflamapimod in the extension period showed stabilization or improvement in basal forebrain volume. He said the findings could reflect recovery of shrunken neurons after treatment of the underlying disease process, rather than solely prevention of neuronal death.
Regulatory status and partnership discussions
CervoMed submitted its DLB data to the United Kingdom’s Innovative Licensing and Access Pathway, or ILAP, and received an Innovation Passport designation. Alam said the submission included the placebo-controlled analysis of the lower-exposure capsule batch, which had not previously been reviewed by regulators.
He said the U.K. Medicines and Healthcare products Regulatory Agency, or MHRA, and the U.S. Food and Drug Administration have aligned on CDR-SB as the primary endpoint and on the design of a single Phase III trial. However, he said the U.K. designation evaluates a product’s potential value through approval and patient access, including an element involving the National Health Service.
Alam said CervoMed is in discussions regarding a strategic partnership to advance neflamapimod’s Phase III program. He did not provide a timeline, saying the company is considering multiple partnership structures and does not want to pursue a deal prematurely.
Additional programs in PPA and ALS
Beyond DLB, CervoMed enrolled 25 patients in what Alam described as the first mechanism-based therapeutic trial in nf-vPPA, a subtype of frontotemporal dementia. He said nf-vPPA affects approximately 15,000 people in the United States and currently has no available treatments.
The company has reviewed preliminary biomarker data from the first eight patients and considers the results encouraging, Alam said, while emphasizing that the dataset remains early. CervoMed plans to present 12-week neurofilament light chain data at the International Society for Frontotemporal Dementias meeting in October and expects to have most 24-week data available for the Clinical Trials on Alzheimer’s Disease meeting later in the year.
In ALS, Alam said CervoMed is working with a U.K. group on the EXPERTS-ALS trial and plans to use neflamapimod at a 50-milligram, three-times-daily dose. The study is expected to start by year-end, with data anticipated late next year, he said.
About CervoMed (NASDAQ:CRVO)
CervoMed Inc, a biotechnology company, engages in the development and commercialization of treatments for age-related neurologic disorders. Its lead drug candidate is neflamapimod, an orally administered small molecule brain penetrant for the treatment of dementia with Lewy bodies (DLB), Alzheimer's diseases, frontotemporal dementia, and ischemic stroke recovery. The company also develops EIP200 for central nervous system which is in preclinical trials. CervoMed Inc was founded in 2010 and is headquartered in Boston, Massachusetts.
