CervoMed is already in the planning stages for the next trial with neflamapimod in dementia with Lewy bodies, CEO Dr John Alam told Clinical Trials Arena.
The US-based company has already had discussions with the US Food and Drug Administration (FDA) about what is required in terms of a Phase III trial.
Alam shared that the trial will likely recruit 300 patients, but the specific number will be decided after a data readout from the ongoing Phase IIb trial. CervoMed is likely to focus on early-stage dementia with Lewy bodies population.
In the long run, Alam said that the company will conduct research in the more advanced population, most likely as a parallel trial or as a post-marketing study. The Phase III trial is likely to be initiated in 2025, with data readout and filling for approval expected two years later.
While there are approved treatments such as acetylcholinesterase inhibitors to help treat the disease symptomatically, Alam said they are transient and there is a need for disease-modifying drugs.
Neflamapimod is an oral p38MAP kinase alpha (p38a) inhibitor that has the potential to treat synaptic dysfunction. It is the reversible aspect of the underlying neurodegenerative processes in dementia with Lewy bodies.
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CervoMed was recently formed after the merger completion of EIP Pharma and Diffusion Pharmaceuticals.
The ongoing Phase IIb trial
CervoMed is currently conducting a Phase IIb trial with neflamapimod. The company dosed its first patient in August.
The Phase IIb trial (NCT05869669) will randomise 160 patients into treatment and placebo cohorts in a 1:1 ratio. At the end of the 16-week placebo-controlled period, there will be a 32-week open-label extension so all participants will receive a minimum of eight months of the active drug.
The company plans to fully enrol the trial within the first half of next year, with topline data expected by the end of 2024.
CervoMed has opened 40 sites. The majority of sites are based in the US while the rest of them are in the UK and the Netherlands. Alam said that in the long run, the company wants to expand outside Europe and the US, but it would only be done with a partner. The company recently presented new statistical calculations that included simulations based on Phase IIa data.
He said: “This is a drug that deserves to be accessible to patients everywhere.”
A recent GlobalData report estimates that the highest diagnosed prevalent cases of dementia with Lewy bodies will be in China and India in 2028. Additionally, the therapeutic management of the disease has not changed substantially in the past decade.
GlobalData is the parent company of Clinical Trials Arena.