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Cerevance buoyed by postive clinical trial results for schizophrenia compound

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Cambridge Science Park-based Cerevance has confirmed positive results from a trial of a potential treatment for cognitive impairment associated with schizophrenia.

The private drug discovery and development company, which is focused on brain diseases, said the findings of the Phase 1b clinical trial of its oral compound - CVN058 - were encouraging for the millions of people living with schizophrenia with comorbid cognitive impairment.

Mark Carlton, chief scientific officer of Cerevance (34747000)
Mark Carlton, chief scientific officer of Cerevance (34747000)

Dr David H Margolin, senior vice president of clinical and translational medicine at Cerevance, said: “A single dose of CVN058 elicited a statistically significant improvement in mismatch negativity (MMN), an auditory evoked potential generated in the cerebral cortex that is typically impaired in schizophrenics.

“The normalisation of MMN brainwaves, a biomarker of cortical dysfunction, leads us to believe our approach can potentially improve diverse aspects of cognition in schizophrenic patients.”

Cognitive impairment associated with schizophrenia (CIAS) can lead to deficits in attention, working memory and executive function. Such symptoms in schizophrenia are well characterized, but there are no formal diagnostic criteria and no approved treatments.

CVN058 is a novel, brain-penetrant, small-molecule antagonist of the type 3 receptor for serotonin, which is an important neurotransmitter.

The double-blind, placebo-controlled, three-period cross-over study evaluated its target engagement in the cerebral cortex by measuring mismatch negativity (MMN) as a pharmacodynamic marker.

Nineteen male and female subjects with schizophrenia or schizoaffective disorder, aged 18-50, received a single oral dose or matching placebo at each study visit and MMN and other cortical biomarkers were recorded in the hours after dosing.

Cerevance said the sequence in which a subject took each of the three regimens was randomised, with a minimum of a seven-day ‘washout’ between doses, and no serious or severe adverse effects were reported.

Dr Daniel C Javitt, lead investigator and a world-renowned researcher in the study of schizophrenia and cognition, said: “The cognitive impairment experienced by many patients with schizophrenia desperately needs an effective treatment.

“We are very encouraged by CVN058’s results in our MMN translational study and look forward to confirming its potential cognitive benefits in future clinical trials.”

Dr Javitt directs the schizophrenia research program at the Nathan S Kline Institute for Psychiatric Research and is also professor and director of the Division of Experimental Therapeutics in the Department of Psychiatry and Neuroscience at Columbia University College of Physicians and Surgeons.

Brad Margus, CEO of Cerevance. Picture: Vance Jacobs 2016 (34746993)
Brad Margus, CEO of Cerevance. Picture: Vance Jacobs 2016 (34746993)

By 2022, more than four million diagnosed prevalent cases of schizophrenia with comorbid cognitive impairment are expected in the seven major pharmaceutical market.

Cerevance, also based in Boston, Massachusetts, is applying new technology called NETSseq to reveal transcriptional and epigenetic differences between specific cell types in mature human brains.

It profiles neuronal and glial cell populations in unprecedented depth.

The company has partnered with 17 brain banks around the world, assembling a growing collection of more than 8,000 clinically annotated, human brain tissue samples from healthy and diseased donors spanning nine decades in age.

Cerevance’s scientists are applying NETSseq to specific cell types critical to circuits disrupted by disease and comparing vulnerable and resilient cell populations.

This approach is helping the company identify targets and advance a pipeline of novel therapeutics.

Cerevance, which raised $45million in May from investors including Bill Gates, is a finalist in the Cambridge Independent Science and Technology Awards 2020, shortlisted in both Biotech Company of the Year and Life Science Company of the Year categories.

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