Biohaven Receives FDA May Proceed Letter And Initiates Phase 2/3 Clinical Trial Of Trigriluzole (BHV-4157) In Alzheimer's Disease

NEW HAVEN, Conn., July 24, 2018 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) ("Biohaven" or the "Company") announced today that it initiated a Phase 2/3 clinical trial of trigriluzole (BHV-4157), a novel glutamate modulator, in patients with mild-to-moderate Alzheimer's disease (AD).  The initiation of this trial follows Biohaven's filing of an investigational new drug application (IND) for trigriluzole in AD and receipt from FDA of authorization to proceed with clinical investigation in this indication. The trial is being conducted in collaboration with the Alzheimer's Disease Cooperative Study (ADCS), as previously announced, and the first AD patient is expected to enroll in the coming weeks.   

Vlad Coric, M.D., CEO of Biohaven, commented, "We are very pleased with the FDA's acceptance of the IND for trigriluzole for the treatment of Alzheimer's disease. We have designed our Phase 2/3 trial to serve as a well-controlled trial that, if positive, may contribute to establishing the effectiveness of trigriluzole for the treatment of Alzheimer's disease."

Alzheimer's disease is a progressive, fatal neurodegenerative dementia that accounts for 60 - 80 percent of dementia cases.  Alzheimer's disease currently has no cure. Although there are FDA-approved medications for symptomatic treatment of AD, their clinical benefits are generally limited. Novel therapeutic approaches aimed at normalizing synaptic and extra-synaptic glutamate levels, such as trigriluzole, may offer the potential for symptomatic benefit in AD by improving cognitive function, as well as the potential for disease modification by preventing the loss of synapses.

Phase 2/3 Alzheimer's Disease Clinical Trial of Trigriluzole
The Phase 2/3 clinical trial is a randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of trigriluzole in patients diagnosed with AD of mild-to-moderate severity (Mini-Mental State Examination scores of 14-24 at screening).  Patients who have been taking stable doses of FDA-approved AD medications (acetylcholinesterase inhibitors (AchEI) and/or memantine) for a minimum of three months prior to screening and who are willing to remain on the same regimen for the duration of the trial may be eligible to participate. Approximately 292 patients will be randomized on a 1:1 basis to receive 280 mg of trigriluzole or placebo, taken orally at bedtime. Duration of treatment will be 48 weeks.

About Trigriluzole

Trigriluzole is a third-generation prodrug and new chemical entity that modulates glutamate, the most abundant excitatory neurotransmitter in the human body. Trigriluzole has a wide range of pharmacological actions, including interactions with several types of ion channels, cellular signaling mechanisms and facilitation of glutamate reuptake. Some potential targets related to trigriluzole's mechanism of action include (1) reducing presynaptic glutamate release through actions at the voltage-gated ion channels, (2) facilitating glutamate uptake via EAATs located on glial cells, (3) enhancing transmission through synaptic AMPA receptors, (4) altering GABAergic neurotransmission, and (5) effecting neurotrophic agents such as BDNF. Several of these targets of trigriluzole balance abnormalities observed in human AD post-mortem tissue as well as in AD animal models. As such, trigriluzole potentially offers neuroprotective effects at the level of the synapse as well as improved synaptic functioning, mechanisms that could exert both symptomatic and disease-modifying effects in AD.

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 combined internal development and research with intellectual property licensed from companies and institutions including Bristol-Myers Squibb Company, AstraZeneca AB, Yale University, Catalent, 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 and regulatory pathway for trigriluzole in the treatment of AD, the mechanisms of action of trigriluzole and their potential symptomatic and disease-altering effects in AD, trigriluzole's expected improved pharmaceutical properties over its active metabolite and the timeline for enrollment in the Phase 2/3 clinical trial, are forward-looking statements. The use of certain words, including "potential", "believe", "could", "expect", "may" 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 trigriluzole in AD, and whether the results observed in previous pre-clinical studies and clinical trials of trigriluzole and its active metabolite will be observed in Biohaven's future clinical trials of trigriluzole in AD. 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 May 15, 2018. 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.

CONTACT: For further information, contact Dr. Vlad Coric, the Chief Executive Officer, at [email protected].

SOURCE Biohaven Pharmaceutical Holding Company Ltd.

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