Vistagen Announces European Patent Office Intention to Grant New PH80 Nasal Spray Patent for the Treatment of Migraine
13 Junho 2023 - 9:00AM
Business Wire
Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical
company aiming to transform the treatment landscape for individuals
living with anxiety, depression, and other central nervous system
(CNS) disorders, today announced that the European Patent Office
(EPO) issued an intention to grant a patent for the treatment of
migraine by nasal administration of PH80 nasal spray, one of the
Company’s five rapid-onset investigational neuroactive pherine
therapeutics. The patent claims also include treatment administered
at the onset of migraine symptoms and treatment of migraines
associated with traumatic brain injury. The patent, once granted,
will not expire until at least 2040. The U.S. Patent and Trademark
Office (USPTO) recently granted a related U.S. patent for
Vistagen’s PH80 nasal spray for treatment of migraine and similar
patent applications are pending in several additional major
pharmaceutical markets.
PH80 is a clinical-stage investigational pherine nasal spray
designed with a potential rapid-onset mechanism of action (MOA)
that is fundamentally differentiated from all currently approved
treatments for migraine. PH80’s proposed MOA does not require
systemic exposure to produce a therapeutic effect, providing a
significant potential treatment advantage over traditional
pharmaceuticals targeted at the CNS, including current treatments
for migraine. PH80 nasal spray initiates neural impulses in the
olfactory bulb transmitted by pathways that rapidly affect the
function of multiple structures in the brain, including the
amygdala and hypothalamus, which have been linked to the pathology
of migraine.
About PH80
PH80 nasal spray is a first-in-class, rapid-onset product
candidate, designed to be used in a manner analogous to a rescue
inhaler for asthma, with user-friendly, patient-tailored intranasal
administration as-needed up to multiple times daily. The proposed
rapid-onset mechanism of action of PH80 nasal spray is
fundamentally differentiated from all currently approved treatment
options for migraine and does not require systemic uptake or direct
action on CNS neurons. PH80 has demonstrated an excellent safety
profile in all clinical trials to date. Vistagen’s PH80 development
program is currently focused on both the acute management of
menopausal hot flashes and acute treatment of migraine.
About Migraine
Migraine affects more than one billion individuals each year
across the world and is one of the most common neurological
disorders. Migraine is characterized by recurrent attacks of
moderate to severe throbbing and pulsating pain on one side of the
head and, left untreated, can last from four to 72 hours with
debilitating symptoms such as nausea, vomiting, and increased
sensitivity to light, noise, and odors. While approved treatments
exist for migraine, many individuals could benefit from safer and
more efficacious treatment options.
About Vistagen
Vistagen (Nasdaq: VTGN) is a late clinical-stage
biopharmaceutical company aiming to transform the treatment
landscape for individuals living with anxiety, depression and other
CNS disorders. Vistagen is advancing therapeutics with the
potential to be faster-acting, and with fewer side effects and
safety concerns, than those currently available for treating
anxiety, depression and multiple CNS disorders. Vistagen’s pipeline
includes six clinical-stage product candidates, including five
investigational agents belonging to a new class of neuroactive
drugs known as pherines, in addition to AV-101, an oral antagonist
of the glycine site of the N-methyl-D-aspartate receptor (NMDAR).
Pherines, which are administered as nasal sprays, are designed with
an innovative rapid-onset mechanism of action that activates
chemosensory neurons in the nasal passages and can selectively and
beneficially impact key neural circuits in the brain without
requiring systemic uptake or direct activity on CNS neurons.
Vistagen’s AV-101 inhibits activity of the ion channel of the NMDAR
but does not block it, unlike some approved therapeutics having
significant side effects. Vistagen is passionate about transforming
mental health care and redefining what is possible in the treatment
of anxiety, depression and several other CNS disorders. Connect at
www.vistagen.com.
Forward Looking Statements
This press release contains certain forward-looking statements
within the meaning of the federal securities laws. These
forward-looking statements involve known and unknown risks that are
difficult to predict and include all matters that are not
historical facts. In some cases, you can identify forward-looking
statements by the use of words such as “may,” “could,” “expect,”
“project,” “outlook,” “strategy,” “intend,” “plan,” “seek,”
“anticipate,” “believe,” “estimate,” “predict,” “potential,”
“strive,” “goal,” “continue,” “likely,” “will,” “would” and
variations of these terms and similar expressions, or the negative
of these terms or similar expressions. Such forward-looking
statements are necessarily based upon estimates and assumptions
that, while considered reasonable by Vistagen and its management,
are inherently uncertain. As with all pharmaceutical products,
there are substantial risks and uncertainties in the process of
development and commercialization and actual results or development
may differ materially from those projected or implied in these
forward-looking statements. Among other things, there can be no
guarantee that the scope of protection and enforceability provided
by any patents issued for any of the Company’s drug candidates,
including PH80, will be sufficient to deter competition, or that
any of the Company’s drug candidates, including PH80, will
successfully complete ongoing or future clinical trials, receive
regulatory approval or be commercially successful. Other factors
that may cause such a difference include, without limitation, risks
and uncertainties relating to the Company’s ability to secure
adequate financing for its operations, including financing or
collaborative support for continued clinical development of the
Company’s product candidates; other risks and uncertainties related
to delays in launching, conducting and/or completing ongoing and
planned clinical trials; fluctuating costs of materials and other
resources and services required to conduct the Company’s ongoing
and/or planned clinical and non-clinical trials; market conditions;
the impact of general economic, industry or political conditions in
the United States or internationally; and other technical and
unexpected hurdles in the development, manufacture and
commercialization of the Company’s drug candidates. These risks are
more fully discussed in the section entitled "Risk Factors" in the
Company’s most recent Annual Report on Form 10-K for the fiscal
year ended March 31, 2022, and in the Company’s most recent
Quarterly Report on Form 10-Q for the quarter ended December 31,
2022, as well as discussions of potential risks, uncertainties, and
other important factors in our other filings with the U.S.
Securities and Exchange Commission (SEC). The Company’s SEC filings
are available on the SEC’s website at www.sec.gov. Additionally,
you should not place undue reliance on these forward-looking
statements in the future, because they apply only as of the date of
this press release and should not be relied upon as representing
the Company’s views as of any subsequent date. The Company
explicitly disclaims any obligation to update any forward-looking
statements, other than as may be required by law. If the Company
does update one or more forward-looking statements, no inference
should be made that the Company will make additional updates with
respect to those or other forward-looking statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20230613270446/en/
Investors: Mark McPartland Senior Vice President, Investor
Relations (650) 577-3606 markmcp@vistagen.com
Media: Nate Hitchings SKDK nhitchings@skdknick.com
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