WASHINGTON, Jan. 31,
2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc.
(Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug
Administration (FDA) has approved the Investigational New Drug
(IND) application to evaluate VTR-297 for the treatment of
onychomycosis.
Onychomycosis, or tinea unguium, is a fungal infection of the
nail. Onychomycosis can result in discoloration of the nail,
onycholysis (nail separation from the nail bed), and nail plate
thickening. Onychomycosis accounts for one half of all nail disease
with an estimated U.S. prevalence of up to 14%.1 In
addition to cosmetic issues, onychomycosis infection may indirectly
decrease peripheral circulation, thereby worsening conditions such
as venous stasis and diabetic foot ulcers.2
"The initiation of clinical studies with VTR-297 in the
treatment of onychomycosis is an important milestone in studying
and developing potential new therapies for this common disorder,"
said Mihael H. Polymeropoulos, M.D.,
Vanda's President, CEO and Chairman of the Board.
VTR-297 is a small molecule histone deacetylase (HDAC) inhibitor
with activity against dermatophytes and fungi, originally isolated
from the yeast species Streptomyces hygroscopicus as an antifungal
antibiotic, first described in 1976.3 Current therapies
for onychomycosis include topical agents JUBLIA®
(efinaconzole), KERYDIN® (tavaborole), and
PENLAC® (ciclopirox). There have not been any new
onychomycosis treatments approved by the FDA since
2014.4
References
- Centers for Disease Control and Prevention. Fungal Nail
Infections. Updated September 13,
2022. Accessed January 30,
2024. Available
online: https://www.cdc.gov/fungal/nail-infections.html
- Scher, R. Onychomycosis: a significant medical disorder. J
Am Acad Dermatol. 35, S2–5 (1996). Available online:
https://doi.org/10.1016/s0190-9622(96)90061-4
- Tsuji, N., Kobayashi, M., Nagashima, K., Wakisaka, Y., Koizumi,
K. A New Antifungal Antibiotic, Trichostatin. J Antibiot
(Tokyo). 1976 Jan;29(1):1-6.
Available online: https://doi.org/10.7164/antibiotics.29.1
- Markham, A. Tavaborole: First Global Approval. Drugs 74,
1555–1558 (2014). Available online:
https://doi.org/10.1007/s40265-014-0276-7
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 the estimated prevalence of
onychomycosis and the development of new antifungals, are
"forward-looking statements" under the securities laws. All
statements other than statements of historical fact are statements
that could be deemed forward-looking statements. Forward-looking
statements are based upon current expectations and assumptions 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 accuracy of the reporting and
diagnosis of onychomycosis and onychomycosis cases and the ability
to successfully complete the clinical development of, and obtain
regulatory approval for, VTR-297 in the treatment of onychomycosis.
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 most recent Annual Report on Form
10-K, 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
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SOURCE Vanda Pharmaceuticals Inc.