WASHINGTON, Dec. 2, 2022
/PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA)
today reported results in a Phase II clinical study of VQW-765, a
novel small molecule alpha 7 nicotinic acetylcholine receptor
(α7-nAChR) partial agonist, in the treatment of acute performance
anxiety in social situations, such as public speaking.
In clinical study VP-VQW-765-2201 (Study 2201), 230 volunteers
with prior history of performance anxiety were randomized to
receive a single dose of VQW-765 or placebo and were challenged
with the standardized Trier Social Stress Test (TSST). The TSST
creates an acute stress by requiring participants to make an
interview-style presentation in front of a panel who provides no
feedback or encouragement. Participants who received VQW-765 showed
numerically lower stress levels compared to those who received
placebo.
In Study 2201, the stress level was assessed by the Subjective
Units of Distress Scale (SUDS), a self-rating scale of level of
nervousness or distress ranging from 0 to 100 at multiple
timepoints during the duration of the TSST. In particular, female
participants (approximately 70% of the total participants) reported
a larger magnitude and statistically significant response to
VQW-765. A higher stress reaction in females (as well as higher
prevalence of performance anxiety) as compared to male participants
is consistent with prior reports in this particular test of acute
performance anxiety.1 A significant relationship was
also seen between exposure to VQW-765 (amount of drug measured in
blood) and the clinical response.
This is the first time that an alpha 7 nicotinic acetylcholine
receptor (α7-nAChR) partial agonist has shown efficacy in a
clinical study of performance anxiety. The observed significant
relationship between exposure and clinical outcome further supports
the hypothesis that VQW-765 could be effective in treating
performance anxiety and creates a valuable roadmap to future
confirmatory studies. Clinical data gathered indicates an adverse
event profile similar to placebo and there were no observed
negative cognitive effects reported by any participant in Study
2201. If the results of the current study are confirmed, VQW-765
could be the first drug in the class of nicotinic receptor agonists
approved to treat performance anxiety.
About VQW-765
VQW-765 is a novel small molecule alpha 7 nicotinic
acetylcholine receptor (α7-nAChR) partial agonist, with potential
use for the treatment of psychiatric disorders. VQW-765 binds and
enhances the activity of one type of nicotinic receptors composed
of a pentameric assembly of the alpha 7 subtype. While nicotine can
also bind this receptor, the binding affinity of VQW-765 is much
higher than nicotine itself making it a potent and specific
molecule for the alpha 7 receptor. VQW-765, formerly known as
AQW-051, was licensed to Vanda from Novartis.
About Performance Anxiety
An estimated over 20% of the U.S. population experiences
debilitating performance anxiety that ranges from public speaking
to test taking, writer's block and musical performance.2,
3 The most common type of performance anxiety is public
speaking anxiety. People with performance anxiety report that the
condition can hinder or even threaten their professional career of
choice. Similarly, musicians report that performance anxiety makes
them perform at levels below their capabilities. Currently, there
is no FDA-approved drug treatment available for performance anxiety
and general anti-anxiolytic drugs tend to be sedating which is not
preferred in a performance situation.
References
- Santl, J., Shiban, Y., Plab, A., Wüst, S., Kudielka, B. M.,
& Mühlberger, A. (2019). Gender Differences in Stress Responses
during a Virtual Reality Trier Social Stress Test. International
Journal of Virtual Reality, 19(2).
https://doi.org/10.20870/ijvr.2019.19.2.2912
- Stein, M. B., Walker, J. R., & Forde, D. R. (1996).
Public-Speaking Fears in a Community Sample. Prevalence, Impact on
Functioning, and Diagnostic Classification. Archives of
general psychiatry, 53(2), 169–174.
https://doi.org/10.1001/archpsyc.1996.01830020087010
- Ebrahimi, O. V., Pallesen, S., Kenter, R. M., & Nordgreen,
T. (2019). Psychological Interventions for the Fear of Public
Speaking: A Meta-Analysis. Frontiers in Psychology,
10. https://doi.org/10.3389/fpsyg.2019.00488
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 clinical development plan
and strategies for VQW-765 and the safety and efficacy of VQW-765,
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, the ability of VQW-765 to safely
and effectively treat performance anxiety and Vanda's ability to
complete the clinical development of, and obtain regulatory
approval for, VQW-765. 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. 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,
2021, 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.