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July 21, 2016

Biohaven starts dosing patients in first clinical trial of BHV-4157

US-based biopharmaceutical company Biohaven has initiated dosing the first patient in its initial clinical trial of BHV-4157.

US-based biopharmaceutical company Biohaven has initiated dosing the first patient in its initial clinical trial of BHV-4157.

BHV-4157 is a pro-drug form involving the modulation of the glutamate system, which is considered as the most important neurotransmitters in the brain and present in more than 90% of all brain synapses.

The clinical trial has been designed to determine the safety, tolerability and pharmacokinetics profile of BHV-4157 administered in single and multiple ascending doses.

Biohaven CEO Dr Vlad Coric said: “Reaching this step in the clinical development process is a very exciting moment for Biohaven and brings us one step closer to our ultimate goal of testing BHV-4157 for efficacy in patent populations.

"We continue to remain on track to begin our phase III registrational trial in SCA over the coming months."

“Our first dosing in this pharmacokinetic study represents the culmination of many years of chemistry discovery work and pre-clinical studies that are required to safely begin dosing a NCE in clinical trials.

“We continue to remain on track to begin our phase III registrational trial in SCA over the coming months.”

Biohaven’s new chemical entity (NCE), BHV-4157 modulates glutamate neurotransmission, which is believed to possess therapeutic potential in treating a range of disease states such as glutamate dysfunction, including ALS, Alzheimer’s disease, Rett syndrome, dementia, dystonia and tinnitus.

BHV-4157 is also designed to treat affective disorders such as major depressive disorder and anxiety disorders.

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