NEW HAVEN, Conn., Dec. 17, 2019 /PRNewswire/ -- Biohaven
Pharmaceutical Holding Company Ltd. (NYSE: BHVN) today announced
positive topline results from its randomized, dose ranging, placebo
controlled, pivotal Phase 2/3 clinical trial (BHV3500-201;
NCT03872453) evaluating the efficacy and tolerability of intranasal
vazegepant 5, 10 and 20 mg versus placebo in 1,673 patients for the
acute treatment of migraine. Vazegepant 10 and 20 mg was
statistically superior to placebo on the co-primary endpoints of
pain freedom and freedom from most bothersome symptom (MBS,
photophobia, phonophobia or nausea) at 2 hours using a single dose
(Table 1). The benefits of vazegepant were durable and
sustained without rescue medication through 48 hours (nominal p
< 0.05), including: sustained pain freedom 2 to 24 hours (5, 10
and 20 mg); sustained pain freedom 2 to 48 hours (5, 10 and 20 mg);
sustained pain relief 2 to 24 hours (5, 10 and 20 mg); and
sustained pain relief 2 to 48 hours (5 and 10 mg). Additional
results from this study are anticipated to be presented at upcoming
scientific meetings in 2020.
Table 1: Vazegepant Met Co-Primary Endpoints of
Pain Freedom & Freedom from Most Bothersome Symptom
2 Hour
Endpoint
|
Vazegepant
|
Placebo
|
5
mg (N=387)
|
10
mg (N=391)
|
20
mg (N=402)
|
(N=401)
|
Pain
Freedom
|
19.6%
|
22.5%
|
23.1%
|
15.5%
|
p-value
|
0.1214
|
0.0113 *
|
0.0055 *
|
|
Freedom from
MBS
|
39.0%
|
41.9%
|
42.5%
|
33.7%
|
p-value
|
0.1162
|
0.0155 *
|
0.0094 *
|
|
* denotes statistical
superiority versus placebo
|
Richard B. Lipton, M.D.,
Professor and Vice Chair of Neurology, and Director of the
Montefiore Headache Center, at the Albert Einstein College of
Medicine commented, "A large number of patients need a non-oral,
acute migraine treatment option, particularly those with prominent
nausea, vomiting or gastroparesis. Most of my patients don't like
needles. Vazegepant is the first CGRP receptor antagonist delivered
in an intranasal formulation, a benefit for patients who need
non-oral therapy. This dose ranging study unequivocally
demonstrates the benefits of vazegepant in the acute treatment of
migraine."
Vazegepant was also superior to placebo on multiple secondary
endpoints demonstrating early activity (nominal p < 0.05).
Vazegepant had rapid onset with pain relief at 15 minutes (10 and
20mg), and return to normal function as early as 30 minutes
(20mg). The 10 and 20 mg vazegepant doses showed therapeutic
benefits on both pain relief and return to normal function at 2
hours.
Intranasal vazegepant was well tolerated in this single
dose trial. Individual adverse events (AEs) greater than 5%
were: dysgeusia (13.5 to 16.1% in the vazegepant arms, and
3.5% in the placebo arm) and nasal discomfort (1.3 to 5.2% in the
vazegepant arms, and 0.2% in the placebo arm). The majority (>
80%) of AEs were mild in intensity. There was no signal of
hepatoxicity as no subjects had AST or ALT > 3x ULN, or total
bilirubin > 2x ULN, in any treatment arm (Table 2).
Table 2: Liver Function Test (LFT)
Profile
Measure1
|
Vazegepant
|
Placebo
|
5
mg (N=388)
|
10
mg (N=394)
|
20
mg (N=403)
|
All (N=1185)
|
(N=403)
|
ALT or AST > 3x
ULN
|
0
|
0
|
0
|
0
|
0
|
Bilirubin > 2x
ULN
|
0
|
0
|
0
|
0
|
0
|
1. ALT alanine
aminotransferase; AST aspartate aminotransferase; ULN Upper limit
of normal
|
Vlad Coric, M.D., Chief Executive
Officer of Biohaven, stated, "Biohaven has now advanced yet another
CGRP signal-targeting product into the clinic highlighting the
value of our migraine platform and the capability of the
organization to develop products that meet patients' needs. This
shows our ability to execute on clinical trials, now delivering our
4th consecutive positive pivotal trial in
migraine." Dr. Coric added, "We are excited to demonstrate
the efficacy and tolerability of the first intranasal CGRP receptor
antagonist for patients with migraine. These positive results, in a
large, multiple arm phase 2/3 dose finding trial, may allow us to
accelerate this program with only one additional positive efficacy
trial likely needed for submission. Biohaven is grateful to
the patients and investigators who have contributed to the success
of the vazegepant and rimegepant programs."
Vazegepant is the newest member of Biohaven's
NOJECTIONTM Migraine Platform to have demonstrated
efficacy in a pivotal trial. The lead product rimegepant Zydis™ ODT
is under FDA review with a first quarter 2020 PDUFA date. Biohaven
believes that intranasal vazegepant will be complementary to other
CGRP targeting agents, including Biohaven's rimegepant.
About Migraine
Over 36 million Americans suffer from migraine. Migraine attacks
can differ in intensity and frequency, with many being highly
disabling. More than 90 percent of migraine sufferers are unable to
work or function normally during an attack. In the Global Burden of
Disease Study, updated in 2015, migraine was ranked as the seventh
highest cause worldwide of years lost due to disability. CGRP
receptor antagonists represent a novel class of drug candidates for
the treatment of migraine and are the first new class specific to
the acute treatment of migraine in over 25 years. This unique and
specific mode of action potentially offers an alternative to
current agents, particularly for patients who have
contraindications to the use of triptans, such as those with
underlying cardiovascular diseases, or who either do not respond or
have inadequate or inconsistent response to triptans or are
intolerant to them.
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. Currently, Biohaven's
lead development programs include multiple compounds across its
CGRP receptor antagonist, glutamate modulation, and myeloperoxidase
inhibitor platforms. Biohaven'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
About Aptar Pharma
Aptar Pharma is part of AptarGroup, Inc., a leading global
supplier of a broad range of innovative dispensing, sealing and
active packaging solutions for the beauty, personal care, home
care, prescription drug, consumer health care, injectables, food
and beverage markets. Aptar uses insights, design, engineering and
science to create innovative packaging technologies that build
brand value for its customers, and, in turn, make a meaningful
difference in the lives, looks, health and homes of people around
the world. Aptar is headquartered in Crystal Lake, Illinois and has over 14,000
dedicated employees in 18 different countries. For more
information, visit www.aptar.com/pharma. Media Contact:
Carolyn Penot, Aptar Pharma, +33 1
39 17 20 38, carolyn.penot@aptar.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 statements about the potential
safety, efficacy and attractive mode of administration of
vazegepant as a treatment for migraine, as well as its potential
for rapid onset and sustained activity, the potential of the
Company's CGRP receptor antagonist drug candidates to provide an
improved, effective and safe treatment option for the acute and
preventive treatment of migraine and the Company's expected
timelines for receipt of data from clinical trials, are
forward-looking statements. The use of certain words, including
"believe," "potential" and "will" and similar expressions, is
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 that topline data is based on preliminary
analysis of key efficacy and safety data, and such data could
change following a more comprehensive review and evaluation of more
extensive data from the trials that the Company has not yet
received, and these preliminary conclusions may not accurately
reflect the complete results of the clinical trials, and
uncertainties relating to the timing for submitting an NDA and the
potential regulatory approval of vazegepant. 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, as updated by the Company's subsequent
Quarterly Report on Form 10-Q for the quarter ended September 30, 2019, filed with the Securities and
Exchange Commission on November 1,
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.
Biohaven Contact
Dr. Vlad Coric
Chief Executive Officer
Vlad.Coric@biohavenpharma.com
View original content to download
multimedia:http://www.prnewswire.com/news-releases/biohaven-achieves-positive-topline-results-in-pivotal-phase-23-study-of-vazegepant-the-first-and-only-intranasal-cgrp-receptor-antagonist-in-clinical-development-for-the-acute-treatment-of-migraine-300976000.html
SOURCE Biohaven Pharmaceutical Holding Company Ltd.