WASHINGTON, July 16, 2019 /PRNewswire/ -- Vanda
Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that
tradipitant, a neurokinin-1 receptor antagonist, was effective in
treating motion sickness in a clinical study conducted in the
Pacific Ocean.
The clinical efficacy results reported today are from the Motion
Sifnos Phase II clinical study. In this study, 126 people with a
prior history of motion sickness were subjected to sea travel in
the Pacific Ocean. Study participants were randomized to
receive either tradipitant or placebo in a blinded fashion.
The study had two primary endpoints: percentage of participants
vomiting, and Motion Sickness Severity Scale (MSSS) Worst
score.
In the overall population, a significantly higher percentage of
participants experienced vomiting in the placebo arm as compared to
the tradipitant arm, 39.7% versus 17.5% respectively, p value =
0.0039. The MSSS Worst score endpoint also favored tradipitant, but
the difference did not reach statistical significance, 3.75 versus
3.4, p value = 0.293 (Table 1).
An exploratory analysis was also performed to evaluate the
effects of tradipitant under "calm" and "rough" seas. Under "calm"
sea conditions, only a small percentage of participants in either
arm experienced vomiting, 26.7% versus 18.2% for placebo and
tradipitant respectively (not significant). A similar MSSS Worst
score was seen between the two groups, 3.32 and 3.40, for placebo
and tradipitant respectively (not significant).
Under "rough" sea conditions, 72.2% of the placebo treated
patients vomited as compared to 15.8% of those treated with
tradipitant, p value = 0.0009. A significant effect was also seen
under "rough" conditions in the MSSS Worst score, 4.57 and 3.19 for
placebo and tradipitant respectively, p value = 0.0235 (Table
1).
Vanda intends to initiate a Phase III program in Motion
Sickness, with a plan to file for marketing authorization in
2020.
Table 1: Results of Motion Sifnos study for the Overall
population and for the Calm and Rough Sea sub-populations.
|
|
Tradipitant
|
Placebo
|
Difference
|
P-value
|
|
ITT*
|
n=63
|
n=63
|
|
|
% Vomiting
|
|
17.5%
|
39.7%
|
22.2%
|
0.0039
|
Worst MSSS
|
|
3.40
|
3.75
|
0.35
|
0.2936
|
|
|
|
|
|
|
|
Calm Sea
|
n=44
|
n=45
|
|
|
% Vomiting
|
|
18.2%
|
26.7%
|
8.5%
|
0.3123
|
Worst MSSS
|
|
3.4
|
3.32
|
-0.09
|
0.8271
|
|
|
|
|
|
|
|
Rough Sea
|
n=19
|
n=18
|
|
|
% Vomiting
|
|
15.8%
|
72.2%
|
56.4%
|
0.0009
|
Worst MSSS
|
|
3.19
|
4.57
|
1.38
|
0.0235
|
* ITT = Intent To Treat
Motion Sickness
Motion Sickness is a disorder that arises often as a response to
real or perceived movement, as occurring during vehicular travel.
Vomiting is the most disturbing symptom of motion sickness,
although the disorder is often accompanied by a constellation of
symptoms that includes nausea, sweating, pallor, headache and
anorexia1.
It is believed that a discrepancy between actual body position
and perceived body position triggers the maladaptive response of
motion sickness2. It is reported that approximately 30%
of the general population suffers from Motion Sickness under
ordinary travel conditions that include sea, air and land
travel3.
Despite the increasing prevalence of the disorder, the
treatments available today, antihistamines and anticholinergics,
were first discovered in the 1940's and found utility in
transporting US troops across the Atlantic Ocean in the post World
War II era.
According to IQVIA data, approximately two to three million
doses of Dramamine, a common motion sickness remedy, are purchased
monthly in the US. Dramamine treated patients represent only
a fraction of the people treated monthly for motion sickness.
Motion sickness is one of the most prevalent episodic disorders
in the world, whose prevalence has dramatically increased with
world population mobility over the last 100 years.
The US Transportation Department, Bureau of Transportation
Statistics, reports 10 billion trips per year in mass transit
(buses and trains), with an additional 965 million passenger trips
in domestic and international air travel4.
Motion Sifnos clinical study
The Motion Sifnos study was a proof of concept Phase II clinical
study. During this randomized double blind placebo controlled
study, 126 people with prior history of motion sickness were
exposed to sea travel in the Pacific Ocean under varied weather
conditions.
Study participants were distributed over seven boat trips that
took place between January and May of 2019 off the coast of
Los Angeles. Sea conditions were
recorded for each trip, as was participant evaluation of the
symptoms of motion sickness. For three of the seven trips, sea
conditions were "rough", conducive to producing motion sickness
with wave heights above 1 meter. For the remaining four trips,
conditions were "calm", with wave heights less than 1 meter and,
therefore, less likely to produce motion sickness. Under "rough"
sea conditions, 72.2% of the placebo treated patients experienced
vomiting compared to only 26.7% under "calm" conditions.
Study participants were randomized to receive tradipitant 170 mg
or placebo by mouth in a blinded fashion, prior to travel
initiation, and reported their symptoms at predetermined time
intervals during the travel period. The study had two primary
endpoints: Percentage of participants vomiting and MSSS Worst
score. The MSSS is a 7 point scale ranging from 0 "no symptoms" to
6 "vomiting".
About Vanda
Vanda is a global biopharmaceutical
company focused on the development and commercialization of
innovative therapies to address high unmet medical needs and
improve the lives of patients. For more on Vanda
Pharmaceuticals Inc., please visit www.vandapharma.com.
References
1. Simon RP, Aminoff MJ, Greenberg DA. Clinical Neurology. 2017.
New York, New York: McGraw-Hill.
2. Reason JT. Motion sickness adaptation: a neural mismatch
model. Journal of the Royal Society of Medicine. 1988: 71:
819-829.
3. Turner M, Griffin MJ. Motion sickness in public road
transport: passenger behavior and susceptibility. Egonomics. 1999:
42: 444-461.
4. US Department of Transportation, Office of the Secretary of
Transportation, Bureau of Transportation Statistics. 2018
Transportation Statistics Annual Report.
FORWARD LOOKING STATEMENTS
Various statements in this release are "forward-looking
statements" under the securities laws. Forward-looking statements
are based upon current expectations that involve risks, changes in
circumstances, assumptions and uncertainties. Important factors
that could cause actual results to differ materially from those
reflected in Vanda's forward-looking statements include
tradipitant's potential to be approved by regulatory authorities
and become an approved treatment for motion sickness and other
factors that are described in the "Risk Factors" and "Management's
Discussion and Analysis of Financial Condition and Results of
Operations" sections of Vanda's annual report on Form 10-K for the
fiscal year ended December 31, 2018 and quarterly report on
Form 10-Q for the quarter ended March 31, 2019, which are on
file with the Securities and Exchange Commission (SEC) and
available on the SEC's website at www.sec.gov. Additional factors
may be set forth in those sections of Vanda's quarterly report on
Form 10-Q for the quarter ended June 30,
2019, to be filed in the third quarter of 2019. In addition
to the risks described above and in Vanda's annual report on Form
10-K and quarterly reports on Form 10-Q, other unknown or
unpredictable factors also could affect Vanda's results. There can
be no assurance that the actual results or developments anticipated
by Vanda will be realized or, even if substantially realized, that
they will have the expected consequences to, or effects on, Vanda.
Therefore, no assurance can be given that the outcomes stated in
such forward-looking statements and estimates will be achieved.
All written and verbal forward-looking statements attributable
to Vanda or any person acting on its behalf are expressly qualified
in their entirety by the cautionary statements contained or
referred to herein. Vanda cautions investors not to rely too
heavily on the forward-looking statements Vanda makes or that are
made on its behalf. The information in this release is provided
only as of the date of this release, and Vanda undertakes no
obligation, and specifically declines any obligation, to update or
revise publicly any forward-looking statements, whether as a result
of new information, future events or otherwise.
Investor Contact:
Jim
Kelly
Executive Vice President & Chief Financial Officer
Vanda Pharmaceuticals Inc.
(202) 734-3428
jim.kelly@vandapharma.com
Media Contacts:
AJ Jones II
Burson Cohn & Wolfe (BCW)
1110 Vermont Avenue, NW, Suite 1200
Washington, D.C. 20005
202-530-0400
pr@vandapharma.com
Elizabeth Van Every
Burson Cohn & Wolfe (BCW)
230 Park Avenue South
New York, NY 10003
212-614-3881
pr@vandapharma.com
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SOURCE Vanda Pharmaceuticals Inc.