Biohaven begins dosing in Phase I trial with lead drug candidate BHV-0223

Portage holds 54% equity interest in Biohaven, which filed an investigational drug application (IND) regarding BHV-0223 and recently secured approval from the US Food and Drug Administration (FDA) to proceed with human testing.

BHV-0223 is formulated using the Zydis ODT fast-dissolve technology under an exclusive worldwide agreement with Catalent.

The company noted that agents that modulate glutamate neurotransmission may have therapeutic potential in multiple glutamatergically driven disease states such as amyotrophic lateral sclerosis (ALS), Alzheimer’s disease, Rett syndrome, dementia, dystonia, tinnitus, anxiety disorders, affective disorders and a variety of cancers.

Portage CEO and Biohaven executive chairman Declan Doogan said: "Dosing of the first human subject with our novel Zydis ODT formulation of BHV-0223 within days of receiving clearance from the FDA demonstrates the Biohaven team’s commitment and readiness to execute the clinical development plan in an expeditious fashion.

"We are now transitioning from research concept into the clinic with plans to launch a fully registrational trial in 2016."

The company noted that the existing treatments almost exclusively target the monoamine or GABA neurotransmitter systems, while there are several approved first-line medications for these disorders.

Biohaven is focused on the identification and development of clinical stage neuroscience compounds targeting the glutamatergic system.