Biohaven Announces Positive Results from Phase 1 Study with BHV-0223

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Biohaven Pharmaceutical Holding Company Limited (d/b/a Biohaven) announced today positive results from a Phase I study with BHV-0223, a glutamate modulating agent. The final study results confirm that the pharmacokinetic, safety, and tolerability data with sublingual BHV-0223 support advancement of its clinical development.

Biohaven Pharmaceutical Holding Company Limited (d/b/a Biohaven) announced today positive results from a Phase I study with BHV-0223, a glutamate modulating agent. The final study results confirm that the pharmacokinetic, safety, and tolerability data with sublingual BHV-0223 support advancement of its clinical development. Additionally, lower doses of BHV-0223 appear to have a similar exposure profile to the current standard of care medication.

BHV-0223 is a unique formulation of riluzole, a glutamate modulating agent, that utilizes the Zydis® ODT fast-dissolve technology under an exclusive worldwide agreement with Catalent.

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. A comparison arm with the generic standard of care riluzole was included in the study to demonstrate potential advantages of the unique BHV-0223 formulation and route of administration. 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 the standard oral tablet formulation of riluzole.

Dosing with BHV-0223 showed favorable pharmacokinetic properties. That is, as compared to the oral tablet formulation, BHV-0223 demonstrated faster absorption and, on a dose-normalized basis, higher peak concentrations and greater exposure. With regard to AEs, the most common AE was transient and mild oral numbness. Of note, there were no severe or serious adverse events (AEs), and the vast majority of AEs were considered mild.

Robert Berman, M.D., Chief Medical Officer of Biohaven commented, “This data is exciting as it shows that our novel formulation is able to achieve equivalent exposures with lower doses of the active pharmaceutical ingredient, thereby reducing overall drug burden to patients. In addition, BHV-0223 provides a new route of administration, especially important for those patients with difficulty swallowing. We believe that BHV-0223 offers tangible benefits over the standard oral formulation.” Biohaven’s plans for BHV-0223 will hinge on feedback from the FDA regarding its previously submitted Pre-Investigational New Drug Application (PIND) meeting request with the FDA for Amyotrophic Lateral Sclerosis.

About Biohaven

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 being developed under FDA 505(b)(2) guidelines. The FDA cleared the company’s Investigational New Drug application (IND) in August 2015. 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(dot)com.

Forward-Looking Statements
This news release includes forward-looking statements within the meaning of the U.S. federal and Canadian securities laws.  These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of the Company’s management. All statements, other than statements of historical facts, included in this press release regarding the Company’s plans and objectives, expectations and assumptions of management are forward-looking statements. The use of certain words, including the words “estimate,” “project,” “intend,” “expect,” “believe,” “anticipate,” “will, ”plan,” “could,” “may” and similar expressions are intended to identify forward-looking statements. The Company may not actually achieve the plans, intentions or expectations disclosed in the forward-looking statements and you should not place undue reliance on the Company’s forward-looking statements. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by our forward-looking statements including receipt of regulatory approvals and market conditions. The forward-looking statements are made as of this date and the Company does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

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Dr. Declan Doogan, Chairman
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