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news.Portage Biotech and Biohaven Pharmaceutical announced that preliminary results from a Phase I study with BHV-0223, a glutamate modulating agent, met its study objectives and supports advancing the asset into late phase clinical development.
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BHV-0223 is a unique formulation of a glutamate modulating agent that utilizes the Zydis® ODT fast-dissolve technology under an exclusive worldwide agreement with Catalent.
Agents that modulate glutamate neurotransmission may have therapeutic potential in multiple glutamatergically driven disease states including amyotrophic lateral sclerosis (ALS), Alzheimer’s disease, Rett syndrome, dementia, dystonia, tinnitus, anxiety disorders, and numerous affective disorders like GAD and OCD.
Affective disorders constitute psychiatric disorders related to anxiety and mood. Despite the significant public health burden of these illnesses and decades of active pharmaceutical research, existing treatments almost exclusively target the monoamine neurotransmitter systems.
While there are numerous approved first-line medications for these disorders, most have similar mechanisms of action and many do not experience remission with first or second-line pharmacologic treatments.
BHV-0223 targets this unmet need and introduces an agent with a novel mechanism to treat these disorders.
The Phase I trial was designed to demonstrate the safety and unique pharmacokinetic characteristics of BHV-0223 in single and then multiple dosing in humans. In the first phase of the study, approximately 10 participants were treated with varying doses of BHV-0223 on four separate occasions.
In the second phase of the trial, participants received multiple daily doses of BHV-0223. The study tested three doses of BHV-0223 along with an oral tablet formulation of the active pharmaceutical ingredient.
Dosing with BHV-0223 showed favorable pharmacokinetic properties and greater exposure than the oral tablet formulation on a dose normalized basis. The pharmacokinetic modeling and analysis of metabolites is pending. The vast majority of adverse events were classified as mild. There were no serious or severe adverse events.
Biohaven chief medical officer Robert Berman said: "This preliminary data is exciting as it demonstrates that we have designed a truly unique formulation of this glutamate modulating agent with advantages over generic competition. Based upon the preliminary pharmacokinetic, safety and tolerability findings, we are moving forward with our plans to begin clinical trials in early 2016."
The Board of Directors of Biohaven also has appointed Vlad Coric, M.D. as Chief Executive Officer. Dr. Coric has had a distinguished academic and pharmaceutical career with more than 15 years of drug discovery and clinical development experience at Yale University School of Medicine and Bristol-Myers Squibb.
Within the pharmaceutical industry, Dr. Coric has worked across therapeutic areas including neuroscience, oncology, immuno-oncology and virology. He has been involved in multiple research and development programs including marketed drugs such as ABILIFY (aripiprazole; partial dopamine agonist), OPDIVO (nivolumab; anti-PD1), YERVOY (Ipilimumab; anti-CTLA-4), DAKLINZA(daclatasvir; NS5A inhibitor) and SUNVEPRA (asunaprevir; NS3 inhibitor).
"I am excited to join Biohaven and bring my drug development background from Yale and Bristol-Myers along with my extensive experience working with Dr. Berman on the glutamatergic system to Biohaven," said Dr Coric.
He added, "I believe our team is well-positioned so that we are not just a neuroscience opportunity but a company that can address multiple pathologies associated with the glutamate."