British Virgin Islands (PRWEB) November 19, 2015
Biohaven Pharmaceutical Holding Company Limited (d/b/a Biohaven) announced today 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. 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 affective 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.
Robert Berman, M.D., Chief Medical Officer of Biohaven commented, “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.”
Biohaven is a privately-held biopharmaceutical company engaged in the identification and development of clinical stage compounds targeting the glutamatergic system. The company has licensed intellectual property from Yale University and Massachusetts General Hospital. Biohaven is owned by a group of investors including Portage Biotech Inc. (OTC Market: PTGEF, Canadian Securities Exchange: PBT.U), Yale University and other private investors. The company's first drug candidate, BHV-0223, is a novel formulation of a glutamate-modulating agent, being developed under FDA 505(b)(2) guidelines. BHV-4157, a prodrug form of the same glutamate modulating agent, is being developed as a New Chemical Entity (NCE). The FDA cleared the company’s Investigational New Drug application (IND) in August 2015 and BIOHAVEN has completed a PK study in humans with the final study report expected by 4Q2015 to enable the Phase 2/3 start in 2016. The company plans to advance other glutamatergic approaches and is actively exploring licenses for additional compounds.
For further information, contact Dr. Declan Doogan, the Chairman at Declan.doogan(at)biohavenpharma.com.
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