WASHINGTON, Feb. 4, 2022 /PRNewswire/ -- Vanda
Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced results
from its Phase III clinical study, VP-VLY-686-3303, evaluating the
efficacy and safety of tradipitant in treating the symptoms of
gastroparesis. The study did not meet its prespecified primary
endpoint which was the difference between drug and placebo on the
change of the severity of nausea from baseline at week 12 of
treatment. Both treatment arms showed significant improvements from
baseline on nausea as well as the other core symptoms of
gastroparesis.
Initial exploratory analysis has identified potential
confounders that may have masked the beneficial effect of the drug
previously observed in the Phase II study of tradipitant, which
include a baseline imbalance of rescue medication use between the
two treatment arms as well as an observed poor compliance with
study drug for some patients in the study. When restricting the
analysis in the group of patients that used no rescue medications
at baseline and adjusting for poor compliance, Vanda identified
strong evidence of a drug effect across a number of symptoms and
across the duration of the study, including a significant and
meaningful effect at the prespecified primary endpoint of nausea
change at week 12.
The Phase III study also continued to demonstrate that
tradipitant is safe and well-tolerated, as seen in previous studies
over the 12 weeks of treatment. Patients on tradipitant experienced
a similar number of treatment emergent adverse events as patients
receiving placebo. The most common adverse event where tradipitant
frequency was higher than placebo was diarrhea. Patients that
participated in the clinical program also had the opportunity to
seek expanded access to tradipitant based on the benefit in the
study and their individual unmet medical needs. Ten patients have
received more than 3 months of tradipitant treatment, 6 of whom
have received at least 1 year of tradipitant treatment.
"While disappointed that the study did not meet its prespecified
outcome, we are encouraged by the evidence that is emerging from
further analysis that confirms observations made in the prior
clinical study," said Mihael H.
Polymeropoulos, M.D., Vanda's President, CEO and Chairman of
the Board. "We are committed to completing our analysis and working
to bring tradipitant to patients with gastroparesis to fill a
significant unmet medical need."
Vanda plans to continue the analysis of the data of this study
and prepare the results for submission to peer review journals as
well as prepare the data for submission to regulatory
authorities.
Conference Call
Vanda intends to schedule a conference call to discuss these
results in the coming weeks. Details on timing and instructions to
access the call will be publicly announced in advance.
About Tradipitant
Tradipitant is a neurokinin-1 receptor antagonist licensed by
Vanda from Eli Lilly and Company. Tradipitant is currently in
clinical development for gastroparesis and motion sickness. The FDA
has imposed a partial clinical hold on tradipitant clinical
protocols of longer than 12 weeks duration.
About Gastroparesis
Gastroparesis is a serious medical condition characterized by
delayed gastric emptying associated with the symptoms of nausea,
vomiting, bloating, fullness after meals and abdominal pain, along
with significant impairment of social and occupational functioning.
The estimated prevalence of gastroparesis in the U.S. is
approximately 6 million patients, many of whom remain
undiagnosed.1 Gastroparesis affects mostly women and it
can be of diabetic, idiopathic or other etiology. The only U.S.
Food and Drug Administration approved treatment for gastroparesis
is metoclopramide, approved in 1979, which due to its potential of
severe side effects carries a black box warning and limitations of
use of no more than 3 months. Patients are faced with limited
therapeutic options and clinical guidelines recommend, in addition
to metoclopramide, the off label use of different drugs including
erythromycin, domperidone (not approved in the U.S.), botulinum
toxin injections, gastric stimulators and a variety of surgical
procedures in an effort to relieve even temporarily some of the
symptoms of the disease.2 Gastroparesis treatment
represents a significant unmet medical need as underscored by the
testimonies of interested parties and advocacy organizations
including the International Foundation for Gastrointestinal
Disorders (IFFGD) and Gastroparesis Patient Association for Cures
and Treatments, Inc. (G-Pact).
References
- Rey, E., Choung, R. S., Schleck, C. D., Zinsmeister, A. R.,
Talley, N. J., & Locke, G. R., 3rd (2012). Prevalence of hidden
gastroparesis in the community: the gastroparesis
"iceberg". Journal of neurogastroenterology and
motility, 18(1), 34–42.
https://doi.org/10.5056/jnm.2012.18.1.34
- Camilleri, M., Chedid, V., Ford, A. C., Haruma, K., Horowitz,
M., Jones, K. L., Low, P. A., Park, S. Y., Parkman, H. P., &
Stanghellini, V. (2018). Gastroparesis. Nature reviews.
Disease primers, 4(1), 41.
https://doi.org/10.1038/s41572-018-0038-z
About Vanda Pharmaceuticals Inc.
Vanda is a leading 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 and follow us on Twitter @vandapharma.
CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS
Various statements in this press release, including, but not
limited to statements regarding Vanda's plans for further
analysis of study data and publication of study
results and Vanda's continued pursuit of regulatory
approval of tradipitant for the treatment of the symptoms of
gastroparesis 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, among others, Vanda's ability
to complete the clinical development of, submit a new drug
application for, and obtain regulatory approval of tradipitant in
the treatment of the symptoms of gastroparesis, Vanda's ability to
resolve its disagreement with the FDA regarding the conduct of a
9-month non-rodent chronic toxicity study, and the FDA's assessment
of the adequacy of Vanda's safety and efficacy data. Therefore, no
assurance can be given that the 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.
Forward-looking statements in this press release should be
evaluated together with the various risks and uncertainties that
affect Vanda's business and market, particularly those identified
in the "Cautionary Note Regarding Forward-Looking Statements",
"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, 2020, as updated by Vanda's
subsequent Quarterly Reports on Form 10-Q, Current Reports on Form
8-K and other filings with the U.S. Securities and Exchange
Commission, which are available at www.sec.gov.
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 press release is
provided only as of the date of this press 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,
except as required by law.
Corporate Contact:
Kevin
Moran
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.com
Elizabeth Van Every
Head of Corporate Affairs
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.com
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SOURCE Vanda Pharmaceuticals Inc.