- Phase 2/3 clinical trials of troriluzole, a glutamate modulator, in Alzheimer's disease, generalized anxiety disorder, and obsessive-compulsive disorder are all expected to complete enrollment by end of 2019
- Phase 2/3 clinical trial of troriluzole in Alzheimer's disease has enrolled over 100 patients, enabling the planned futility analysis by end of 2019
- Phase 3 clinical trial of troriluzole in spinocerebellar ataxia is expected to complete enrollment by the first quarter of 2020
- Phase 3 clinical trial of verdiperstat, an oral myeloperoxidase inhibitor, in multiple system atrophy will begin enrollment in third quarter of 2019
- Ongoing non-clinical studies defined under the scientific research agreement with University of Connecticut continue to support the advancement of UC1MT
NEW HAVEN, Conn., May 7, 2019 /PRNewswire/ -- (BHVN) - Biohaven Pharmaceutical Holding Company Ltd. (BHVN), today announced continued progress in its glutamate modulating platform with enrollment expected to complete in three Phase 2/3 clinical trials of troriluzole in Alzheimer's disease, generalized anxiety disorder and obsessive-compulsive disorder by the end of 2019. Enrollment in the spinocerebellar ataxia Phase 3 clinical trial is expected to complete by the first quarter of 2020. In addition, the first Phase 3 trial from the company's myeloperoxidase (MPO) inhibition platform is set to begin by the third quarter of 2019. The study of verdiperstat will examine efficacy and safety of the drug in multiple system atrophy (MSA).
"We continue to advance our late stage assets targeting some of the most disabling neurodegenerative and neuropsychiatric disorders with our novel drug candidates. Our neuroinnovation platforms are evaluating the next generation of treatments for diseases in which there are currently limited or no treatments available," said Vlad Coric, M.D., Chief Executive Officer of Biohaven. "We are looking to efficiently advance these candidates through the clinic and work with regulatory agencies to provide new treatment options for patients with devastating neurological conditions."
Troriluzole, a product candidate in Biohaven's glutamate modulation platform, which modulates the brain chemical glutamate, is currently being studied in four ongoing clinical trials that are expected to complete enrollment this year:
- The Phase 2/3 clinical trial of troriluzole in Alzheimer's disease, which has already enrolled over 100 patients.
- A Phase 3 clinical trial of troriluzole in SCA, an inherited form of ataxia, a rare and progressive neurological disease.
- A Phase 2/3 clinical of troriluzole in generalized anxiety disorder.
- A Phase 2/3 clinical of troriluzole in obsessive-compulsive disorder.
Additionally, Biohaven's first clinical trial from its MPO platform for verdiperstat (formerly known as BHV-3241) is expected to enter a Phase 3 clinical trial in MSA in the third quarter of 2019. A previous Phase 2 clinical trial of Verdiperstat was observed to be generally well tolerated in a previous Phase 2 clinical trial of patients with MSA, with numerical improvements on the change from baseline Unified MSA Rating Scale. Patients with MSA have a life expectancy of 6 to 10 years from the time of symptom onset and there are currently no disease modifying treatments available for MSA.
Beyond neurological indications, Biohaven continues to advance the University of Connecticut collaboration as the metallothionein (MT) program non-clinical program supports lead molecule selection.
About Biohaven's Glutamate Modulation Platform
Biohaven's glutamate modulation platform is comprised of candidates that are designed to balance the glutamate system. Glutamate is an important neurotransmitter present in over 90 percent of all brain synapses and is a naturally occurring molecule that nerve cells use to send signals to other cells in the central nervous system. Glutamate plays an essential role in normal brain functioning and its tight regulation is critical to its proper brain function. Abnormal glutamate release is known to disrupt nerve health, potentially leading to neuronal cell death which is associated with devastating neurogenerative diseases such as amyotrophic lateral sclerosis (ALS), spinocerebellar ataxia (SCA), Alzheimer's disease (AD), anxiety, depression, obsessive-compulsive disorder (OCD), chronic pain, and a variety of cancers. Modulating glutamate has the potential to be neuroprotective and increase the release of neurotrophic factors, including brain derived neurotrophic factor, which are endogenous molecules that help to support the survival of existing neurons, and encourage the growth and differentiation of new neurons and synapses.
About Biohaven's Myeloperoxidase (MPO) Inhibition Platform
Myeloperoxidase (MPO) is one of the most important enzymes for generative oxidative stress and inflammation. MPO levels are increased in a range of brain disorders, and inhibition of MPO activity may reduce production of oxidants that feed neuroinflammatory processes, thereby slowing progression of several neurodegenerative diseases, including MSA. Studies have also linked increased MPO levels with multiple sclerosis and Alzheimer's disease.
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, ALS Biopharma LLC and Massachusetts General Hospital. Currently, Biohaven's lead development programs include multiple compounds across its CGRP receptor antagonist, glutamate modulation and myeloperoxidase inhibition platforms. More information about Biohaven is available at www.biohavenpharma.com.
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 regarding the Company's business and product candidate plans and objectives are forward-looking statements. Forward-looking statements include those related to: the expected timing, commencement and outcomes of the Company's planned and ongoing clinical trials, the timing of planned interactions and filings with the FDA, the timing and outcome of expected regulatory filings, the potential commercialization of the Company's product candidates and the potential for the Company's product candidates to be first in class or best in class therapies. The use of certain words, including "believe", "continue", "may", "on track", "expects" and "will" and similar expressions, are intended to identify 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. Additional important factors to be considered in connection with forward-looking statements are described in the "Risk Factors" section of the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 28, 2019. 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, Chief Executive Officer, at Vlad.Coric@biohavenpharma.com
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