NEW HAVEN, Conn., April 13, 2021 /PRNewswire/ -- Biohaven
Pharmaceutical Holding Company Ltd. (NYSE: BHVN), today announced
that 22 abstracts, including three oral presentations, were
accepted at the 2021 American Academy of Neurology (AAN) virtual
annual meeting being held from April
17 – 22. The abstracts are available on the AAN website at
https://index.mirasmart.com/AAN2021/.
Biohaven will be presenting new data analyses of the company's
FDA-approved acute treatment for migraine in adults, Nurtec® ODT
(rimegepant) that show its efficacy and safety for both the acute
and preventive treatment of migraine, as well as multiple pipeline
assets including: intranasal zavegepant for the acute treatment of
migraine, troriluzole for the treatment of spinocerebellar ataxia
(SCA), and verdiperstat for multiple system atrophy (MSA).
Additional health economic and outcomes research analyses are also
being presented that highlight the clinical utility of Nurtec ODT,
the burden of migraine, and unmet needs of existing treatments.
Elyse Stock, MD, Chief Medical
Officer of Biohaven commented, "The presentation of more than 20
abstracts across therapeutic areas at AAN 2021 demonstrates
Biohaven's continued commitment to neuroscience research excellence
across all of the company's clinical candidates. We are excited
about these analyses reporting on the efficacy and safety of Nurtec
ODT for the acute and preventive treatment of migraine, as well as
advancements in pipeline assets including zavegepant, troriluzole,
and verdiperstat. Nurtec ODT has the potential to provide a unified
approach for the acute and preventive treatment of migraine and we
look forward to the U.S. Food and Drug Administration's decision
for this dual indication later this quarter."
Notable highlights include:
- Phase 2/3 data from the pivotal randomized, placebo-controlled
trial assessing rimegepant for the preventive treatment of migraine
evaluated 695 patients for efficacy. Rimegepant was superior to
placebo on the primary endpoint of change from the observation
period in mean monthly migraine days (MMDs) during weeks 9-12 (−4.3
vs −3.5, p=0.0099) as well as on the secondary endpoint of ≥50%
reduction in mean number of moderate or severe MMDs during weeks
9-12 (49% vs 41%, p=0.0438). A post-hoc analysis showed that
rimegepant demonstrated rapid onset of preventive treatment
efficacy with reductions in migraine days observed within the first
week of every other day dosing.
- Data from a Phase 2/3 dose-ranging study of intranasal
zavegepant, a third-generation, high-affinity, selective and
structurally unique, small molecule calcitonin gene-related peptide
(CGRP) receptor antagonist - the only intranasal CGRP receptor
antagonist currently in late-stage clinical trials for the acute
treatment of migraine. In the study, zavegepant 10 mg and 20 mg
demonstrated statistical superiority to placebo on the co-primary
endpoints of pain freedom [placebo: 15.5%; 5 mg: 19.6% (p=0.1214);
10 mg: 22.5% (p=0.0113); 20 mg: 23.1% (p=0.0055)] and most
bothersome symptom (MBS) freedom [placebo: 33.7%; 5 mg: 39.0%
(p=0.1162); 10 mg: 41.9% (p=0.0155); 20 mg: 42.5% (p=0.0094)].
Rapid onset of pain relief was also observed as early as 15
minutes.
- Preliminary data from a 96-week, open-label extension phase of
Phase 2b/3 study evaluating the
safety and efficacy of troriluzole in adults with spinocerebellar
ataxia suggested attenuation of disease progression in patients
treated with troriluzole. After up to 96 weeks of open-label
treatment with troriluzole, the mean change from baseline in total
SARA score (mean change ± SE) was 0.3 ± 0.30. Patients who had a
gap in troriluzole treatment (3 weeks to 12 months) showed a
greater than 1 point worsening during the off-treatment period.
This worsening increased with longer duration of time off
troriluzole. Improvements in total SARA score were observed after
re-initiation of troriluzole therapy.
The complete list of accepted abstract titles is below and full
presentations will be available on the 2021 AAN virtual annual
meeting website from April 17,
2021.
Oral Presentations:
- Oral Rimegepant 75 mg is Safe and Well Tolerated in Adults with
Migraine and Cardiovascular Risk Factors: Results of a Multicenter,
Long-Term, Open-Label Safety Study
- Intranasal Zavegepant is Effective and Well Tolerated for the
Acute Treatment of Migraine: A Phase 2/3 Dose-Ranging Clinical
Trial
- Analysis of 96 Week, Long-Term Open Label Extension Phase of
Study BHV4157-201: A Phase IIb/III, Randomized, Double-blind,
Placebo-controlled Trial of the Safety and Efficacy of Troriluzole
in Adult Subjects with Spinocerebellar Ataxia
Poster Presentations:
- A Phase 2/3, Randomized, Double-blind, Placebo-controlled Study
to Evaluate the Efficacy and Safety of Rimegepant for the
Preventive Treatment of Migraine
- Long-term Use of Rimegepant 75 mg for the Acute Treatment of
Migraine Reduces Use of Analgesics and Antiemetics
- Rimegepant for the Acute Treatment of Migraine in Patients with
a History of Triptan Treatment Failure: Pooled Results From 3 Phase
3 Clinical Trials
- Long-Term Safety of Rimegepant 75 mg for the Acute Treatment of
Migraine in Adults With a History of Triptan Treatment Failure
- Acute Treatment of Migraine with Rimegepant Improves Health
Related Quality of Life in Adults with a History of Triptan
Treatment Failure: Results from a Long-Term, Open-Label Safety
Study
- Preference for Rimegepant and Improved Clinical Global
Impression of Change Among Adults with a History of Triptan
Treatment Failure: Results from a Long-Term Open-Label Safety
Study
- Rimegepant 75 mg for the Acute Treatment of Migraine in Adults
with Frequent Migraine: Long-Term Safety and Clinical Improvement
Versus Baseline
- Acute Treatment with Rimegepant 75 mg Confers Long Term
Improvements in Median Time to 30% and 50% Reductions in Monthly
Migraine Days – Post Hoc Results from an Open Label Safety Study
(BHVN-3000-201)
- Estimated Migraine Acute-therapy Savings from MMD Reduction
Achieved with Preventive Treatment
- Acute Treatment with Rimegepant 75 mg Confers Clinically
Relevant Improvement in Lost Time (Days) Due to Migraine: Results
From a 1-Year, Open-Label Safety Study (BHV3000-201)
- Migraine Patients Exhibit Increased Risk Of Developing Chronic
Migraine With Sustained Triptan Treatment - Results From A
Large-Scale Real-World Claims Analysis
- Low Rates of Rescue Medication Usage in Subjects Treated with a
Single Dose of Rimegepant 75 mg for the Acute Treatment of
Migraine: Results from 3 Phase 3 Clinical Trials
- Rimegepant is Safe and Tolerable for the Acute Treatment of
Migraine in Patients Using Preventive Migraine Medications: Results
from a Long-Term Open-Label Safety Study
- Migraine Patients Exhibit Increased Risk of Opioid Dependence
with Sustained Triptan Treatment - Results from a Large-Scale
Real-World Claims Analysis
- Migraine Patients Exhibit Risk of Medication Overuse Headache
with Sustained Triptan Treatment - Results from a Large-Scale
Real-World Claims Analysis
- MIDAS Disability Grades are Associated with Total Health Care
and Pharmaceutical Costs – A US-Based Real World Longitudinal
Analysis
- Acute Migraine Medication and Medication Overuse Headache: A
Systematic Literature Review
- MSQ Utility Mapping of Rimegepant by Change in Monthly Migraine
Days
- M-STAR, an Ongoing Phase 3 Study in Participants with Multiple
System Atrophy–Baseline Characteristics
About NURTEC ODT
NURTEC® ODT (rimegepant) is the first and only calcitonin
gene-related peptide (CGRP) receptor antagonist available in a
quick-dissolve ODT formulation that is approved by
the U.S. Food and Drug Administration (FDA) for the acute
treatment of migraine in adults. The activity of the neuropeptide
CGRP is thought to play a causal role in migraine pathophysiology.
NURTEC ODT is a CGRP receptor antagonist that works by reversibly
blocking CGRP receptors, thereby inhibiting the biologic activity
of the CGRP neuropeptide. The recommended dose of NURTEC ODT is 75
mg, taken as needed, up to once daily to treat up to 15 migraine
attacks in a 30-day period. For more information about NURTEC ODT,
visit www.nurtec.com. The most common adverse reaction was
nausea (2% in patients who received NURTEC ODT compared to 0.4% in
patients who received placebo). Avoid concomitant administration of
NURTEC ODT with strong inhibitors of CYP3A4, strong or moderate
inducers of CYP3A or inhibitors of P-gp or BCRP. Avoid another dose
of NURTEC ODT within 48 hours when it is administered with moderate
inhibitors of CYP3A4.
Indication
NURTEC ODT is indicated for the acute treatment of migraine with or
without aura in adults.
Limitations of Use
NURTEC ODT is not indicated for the preventive treatment of
migraine.
Important Safety Information
Contraindications: Hypersensitivity to NURTEC ODT or any of
its components.
Warnings and Precautions: If a serious hypersensitivity
reaction occurs, discontinue NURTEC ODT and initiate appropriate
therapy. Serious hypersensitivity reactions have included
dyspnea and rash, and can occur days after administration.
Adverse Reactions: The most common adverse reaction was
nausea (2% in patients who received NURTEC ODT compared to 0.4% in
patients who received placebo). Hypersensitivity, including
dyspnea and rash, occurred in less than 1% of patients treated with
NURTEC ODT.
Drug Interactions: Avoid concomitant administration of
NURTEC ODT with strong inhibitors of CYP3A4, strong or moderate
inducers of CYP3A or inhibitors of P-gp or BCRP. Avoid another
dose of NURTEC ODT within 48 hours when it is administered with
moderate inhibitors of CYP3A4.
Use in Specific Populations:
- Pregnant/breast feeding: It is not known if NURTEC ODT can harm
an unborn baby or if it passes into breast milk.
- Hepatic impairment: Avoid use of NURTEC ODT in persons with
severe hepatic impairment.
- Renal impairment: Avoid use in patients with end-stage renal
disease.
Please click here for full Prescribing Information.
You are encouraged to report side effects of prescription drugs
to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088 or report side effects to Biohaven at
1-833-4NURTEC.
Please click here for full Prescribing
Information and Patient Information.
About Zavegepant
Zavegepant is a third generation, high affinity, selective and
structurally unique, small molecule CGRP receptor antagonist from
Biohaven's NOJECTION™ Migraine Platform and the only CGRP receptor
antagonist in clinical development with both intranasal and oral
formulations. The efficacy and safety profile of intranasal
zavegepant for the acute treatment of migraine, as compared to
placebo, was shown in a randomized controlled Phase 2/3
dose-ranging trial with a total of over 1000 patients who received
zavegepant. In this study, zavegepant showed statistical
superiority to placebo on the coprimary endpoints of 2 hour freedom
from pain and freedom from a patients' most bothersome symptom
(either nausea, photophobia or phonophobia). Following successful
end of Phase 2 interactions with FDA (clinical and nonclinical),
zavegepant is advancing to Phase 3 for the acute treatment of
migraine in adults. For more information,
visit https://www.biohavenpharma.com/science-pipeline/cgrp/bhv-3500.
About Verdiperstat
Verdiperstat (BHV-3241) is an
investigational first-in-class, potent, selective, brain-penetrant,
and myeloperoxidase (MPO) enzyme inhibitor that Biohaven is
developing for the treatment of neurodegenerative
diseases. Verdiperstat may help preserve neurons through
inhibition of MPO-induced pathological oxidative stress and
inflammation that contribute to cellular injury in
neurodegenerative diseases such as ALS and multiple system atrophy
(MSA). Biohaven licensed verdiperstat (BHV-3241) from AstraZeneca
in September 2018, where it was known
as AZD3241. For more information about the HEALEY ALS Platform
Trial, visit
at www.massgeneral.org/als and clinicaltrials.gov/ct2/show/NCT04436510.
Information about verdiperstat is available at
www.biohavenpharma.com/science-pipeline/mpo/verdiperstat.
About Troriluzole
Troriluzole is a third-generation prodrug and new chemical entity
that modulates glutamate, the most abundant excitatory
neurotransmitter in the human body. The primary mode of action of
troriluzole is normalization of synaptic levels of glutamate.
Troriluzole increases glutamate uptake from the peri-synaptic
space, by augmenting the expression and function of excitatory
amino acid transporters (i.e., EAAT2 also called GLT-1) located on
glial cells that play a key role in clearing glutamate from the
synapse. For more information,
visit https://www.biohavenpharma.com/science-pipeline/glutamate/troriluzole.
About Biohaven
Biohaven is a commercial-stage
biopharmaceutical company with a portfolio of innovative,
best-in-class therapies to improve the lives of patients with
debilitating neurological and neuropsychiatric diseases, including
rare disorders. Biohaven's neuroinnovation portfolio includes
FDA-approved NURTEC ODT (rimegepant) for the acute treatment of
migraine and a broad pipeline of late-stage product candidates
across three distinct mechanistic platforms: CGRP receptor
antagonism for the acute and preventive treatment of migraine;
glutamate modulation for obsessive-compulsive disorder, Alzheimer's
disease, and spinocerebellar ataxia; and MPO inhibition for
multiple system atrophy and amyotrophic lateral sclerosis. More
information about Biohaven is available
at www.biohavenpharma.com.
Forward-looking Statement
This news release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
The use of certain words, including "believe", "may" and "will" and
similar expressions, are intended to identify forward-looking
statements. These forward-looking statements involve substantial
risks and uncertainties, including statements that are based on the
current expectations and assumptions of Biohaven's management about
NURTEC ODT as an acute treatment for patients with migraine.
Forward-looking statements include those related to: Biohaven's
ability to effectively commercialize NURTEC ODT, delays or problems
in the supply or manufacture of NURTEC ODT, complying with
applicable U.S. regulatory requirements, the expected
timing, commencement and outcomes of Biohaven'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 Biohaven's
product candidates, the potential for Biohaven's product candidates
to be first in class or best in class therapies and the
effectiveness and safety of Biohaven's product candidates. 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 March 1, 2021. The
forward-looking statements are made as of this date and Biohaven
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.
NURTEC and NURTEC ODT are registered trademarks of Biohaven
Pharmaceutical Ireland DAC.
Biohaven Contact
Dr. Vlad Coric
Chief Executive Officer
Vlad.Coric@biohavenpharma.com
Media Contact
Mike Beyer
Sam Brown Inc.
mikebeyer@sambrown.com
312-961-2502
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.