UK-based pharmaceutical company Cerevance has announced positive outcomes from its Phase I trial of CVN293, a drug candidate designed to treat neurodegenerative conditions.
The first-in-human single-ascending dose (SAD) and multiple-ascending dose (MAD) study involved 72 healthy volunteers.
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The trial’s SAD portion involved administering a single dose of CVN293, ranging from 3mg to 1,000mg, or placebo to 48 participants.
In the MAD segment, 24 participants received doses from 50mg to 750mg or placebo for a period of 14 days.
Key outcomes from the study indicate that CVN293 was generally well-tolerated at all doses, with no serious adverse events reported.
The trial also observed dose-dependent increases in CVN293 exposure, with plasma concentrations reaching levels deemed clinically relevant based on preclinical studies.
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By GlobalDataIn addition, cerebrospinal fluid sampling showed high brain penetrance of CVN293.
These findings support the drug’s potential progression into Phase II trials for neurodegenerative conditions characterised by neuroinflammation, such as frontotemporal dementia, amyotrophic lateral sclerosis and Alzheimer’s disease.
CVN293’s clinical safety and pharmacokinetic profile have also been deemed favourable.
CVN293 targets KCNK13, a potassium two pore domain channel subfamily K member 13 linked to the activation of the NOD-like receptor family, pyrin domain containing 3 (NLRP3) inflammasome, a component believed to contribute to neuroinflammation.
KCNK13 can be detected using Cerevance’s NETSseq platform, which can pinpoint novel targets even at very low expression levels or within rare cell types.
Cerevance co-founder and chief scientific officer Mark Carlton said: “We are very encouraged by the clinical data for CVN293, observing that it was generally well-tolerated and achieved favourable brain penetration.
“CVN293 selectively inhibits KCNK13, a gene selectively expressed in microglia with minimal expression in peripheral tissues. CVN293 may offer a disease-modifying approach for challenging CNS disorders.”
Cerevance recently secured $47m in a Series B-1 extension round to fund a Phase III trial of CVN424, its drug candidate for treating Parkinson’s disease.
