NEW HAVEN, Conn., Jan. 18, 2018 /PRNewswire/ -- Biohaven
Pharmaceutical Holding Company Ltd. (Biohaven or the "Company")
and its wholly owned subsidiary, Biohaven Pharmaceuticals,
Inc., today announced that the U.S. Food and Drug
Administration (FDA) has notified the Company that it may proceed
with its clinical investigation of BHV-5000. Enrollment of
subjects has started for the IND opening study, which will test
single and multiple doses of a solid-dose formulation of BHV-5000
in healthy volunteers. BHV-5000 is being developed as a
potential treatment for symptoms associated with Rett syndrome,
including breathing irregularities. Biohaven also plans to
explore development of BHV-5000 in other potential future
indications including neuropathic pain and treatment-resistant
depression.
BHV-5000 is a low trapping,
potent N-methyl-D-aspartate (NMDA) receptor antagonist
licensed to Biohaven from AstraZeneca. BHV-5000 was
previously advanced into a Phase 1 clinical trial, as a drug in
solution formulation, and the active metabolite of BHV-5000,
lanicemine, was previously advanced through Phase 2 trials.
Unlike other potent NMDA receptor targeting compounds, BHV-5000 is
a NMDA antagonist that has not been associated with the prominent
psychotomimetic effects. In addition, BHV-5000 is orally
bioavailable.
"BHV-5000 is a novel glutamate receptor antagonist that we are
planning to evaluate for efficacy in neurologic and
neuropsychiatric indications, including Rett syndrome," said
Vlad Coric, M.D., CEO of Biohaven.
"Currently there are no approved drugs for this severe
neurodevelopmental disorder. Advancement of the clinical
investigation of BHV-5000 supports Biohaven's global development
strategy of providing improved therapies for patients suffering
from some of the most disabling neurologic disorders."
"This IND allows Biohaven to study the first solid-dose
formulation of BHV-5000 in healthy volunteers," said Robert Berman, M.D., Chief Medical Officer of
Biohaven. "Based on protocol feedback from the FDA, Biohaven
will initially assess BHV-5000 in single and multiple doses to
characterize its pharmacokinetic and safety profile.
Subsequently, Biohaven plans to advance BHV-5000 into clinical
trials in patient populations. We are eager to advance BHV-5000 in
clinical testing to understand if preclinical effects translate
into therapeutic benefits for patients."
About Biohaven
Biohaven is a clinical-stage biopharmaceutical company with a
portfolio of innovative, late-stage product candidates targeting
neurological diseases, including rare disorders. Biohaven has
combined internal development and research with intellectual
property licensed from companies and institutions including
Bristol-Myers Squibb Company, AstraZeneca AB, Yale University, Catalent, Rutgers, ALS Biopharma LLC and Massachusetts
General Hospital. Currently, Biohaven's lead development programs
include multiple compounds across its CGRP receptor antagonist and
glutamate modulation platforms. The Company's common shares are
listed on the New York Stock Exchange and traded under the ticker
symbol BHVN. More information about Biohaven is available at
www.biohavenpharma.com.
Forward-Looking Statements
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 plans for the clinical
development of BHV-5000, the expected lack of prominent
psychotomimetic effects of BHV-5000 and the potential to expand
clinical development of BHV-5000 into other indications, as well as
the size of the potential market for BHV-5000 in Rett syndrome, are
forward-looking statements. The use of certain words, including the
"believe", "could", "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 BHV-5000, and whether the results observed in previous
clinical trials of BHV-5000 and lanicemine will be observed in
Biohaven's future clinical trials of BHV-5000. 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 November 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
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.