New Haven, Connecticut (NYSE: BHVN) September 11, 2017 – Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a clinical-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological diseases, including rare disorders, will provide an update of its key clinical development programs at the Morgan Stanley 15th Annual Global Healthcare Conference in New York today. The update will be provided by Vlad Coric, MD, CEO of Biohaven, and include the following:
- Biohaven remains on track, or ahead of timelines, in its clinical programs across its two primary technology platforms: oral CGRP-receptor antagonists for patients with migraine, and oral glutamate modulators for patients with spinocerebellar ataxia (SCA) and other severe neurologic conditions that are related to glutamate dysregulation.
- Enrollment and randomization are proceeding strongly in both of the company’s Phase 3 clinical trials of rimegepant, the lead drug candidate in Biohaven’s CGRP-antagonist platform:
- Over 1,200 subjects have been enrolled across the two Phase 3 rimegepant trials for the acute treatment of migraine
- Over 750 subjects have been randomized to treatment across the two Phase 3 rimegepant trials
- Enrollment commenced in the long-term safety trial with rimegepant in August 2017.
- An investigational new drug (IND) filing for BHV-3500, the company’s third generation small molecule CGRP-antagonist, remains on-track for the fourth quarter of 2017.
- The company completed dosing of all subjects in the 8-week treatment phase of trigriluzole (BHV-4157) in the spinocerebellar ataxia trial and the study database has been locked for analysis. Topline results are expected early in the fourth quarter of 2017.
- The company filed an IND for trigriluzole in obsessive compulsive disorder and a Phase 3 trial is expected to commence in the fourth quarter of 2017.
“We are pleased to be driving toward a number of key near term milestones across multiple clinical programs that have the potential to bring patients first-in-class and best-in-class therapies for severe neurologic disorders,” said Dr. Coric. “We will continue to apply our innovative neuroscience and clinical expertise toward helping patients who currently suffer without safe and effective treatments.”
This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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, including the Company’s timing of initiation and the expected data readouts from the Company’s ongoing and planned clinical trials and the expected timing of regulatory filings, are forward-looking statements. The use of certain words, including the “continue,” “expect” and “will” and similar expressions are intended to identify forward-looking statements. The Company may not actually achieve the plans and objectives 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 uncertainties relating to the future clinical success of rimegepant, and whether the results observed in the Phase 2b clinical trial will be observed in the Phase 3 pivotal trials. Additional important factors to be considered in connection with forward-looking statements are described in the “Risk Factors” section of the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 14, 2017. 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, except as required by law.
For further information, contact Dr. Vlad Coric, the Chief Executive
Officer at Vlad.Coric@biohavenpharma.com