Previously completed Phase 2A clinical study of PH10 demonstrated significant antidepressant effects without psychological side effects or safety concerns after only one week of administration
SOUTH SAN FRANCISCO, Calif., Dec. 10, 2020
SOUTH SAN FRANCISCO, Calif., Dec. 10, 2020 /PRNewswire/ -- VistaGen Therapeutics (NASDAQ: VTGN), a biopharmaceutical company developing new generation medicines with the potential to go beyond the current standard of care for anxiety, depression and other central nervous system (CNS) disorders, today announced that the Korean Intellectual Property Office (KIPO) in the Republic of Korea has issued a Decision to Grant Patent Application No. 10-2015-7020176 related to methods of treating depressive disorder with VistaGen's PH10, an investigational neuroactive nasal spray designed to have rapid-onset therapeutic potential in several neuropsychiatric indications involving depression, initially as potential stand-alone treatment for major depressive disorder (MDD). The patent is not set to expire earlier than 2034.
"The Republic of Korea is an important pharmaceutical market. With counterpart patents already issued in the U.S., Greater China, Europe and Japan, this patent enhances our patent protection for PH10 and is a key component of our global commercial protection strategy for PH10," stated Shawn K. Singh, Chief Executive Officer of VistaGen. "Our late-stage development and commercialization strategy for PH10 is similar to our strategy for PH94B, namely, to license these rights in key pharmaceutical markets outside of North America."
"MDD affects more than 264 million adults globally and can have significant emotional, functional and economic impact on those who suffer from the disorder and their loved ones. Recent studies have also shown that there has been an exacerbation of existing depression symptoms, with U.S. adults showing three times as many symptoms of depression during the COVID-19 pandemic we are battling, making the need for better, safer alternatives for depression treatments more imperative. We believe PH10 has the potential to transform the treatment landscape for individuals with MDD in global depression markets, and we believe this patent will help protect and propel global development," continued Mr. Singh.
About Major Depressive Disorder (MDD)
MDD is a serious neurobiologically based mood disorder affecting more than 264 million adults globally and is a leading cause of disability worldwide. Individuals diagnosed with MDD exhibit depressive symptoms, such as a depressed mood or a loss of interest or pleasure in daily activities, for more than a two-week period, as well as impaired social, occupational, educational or other important functioning, which has a negative impact on their quality of life.
PH10 is an innovative odorless investigational synthetic neuroactive nasal spray designed to have rapid-onset and therapeutic potential in several neuropsychiatric indications involving depression, including MDD and suicidal ideation. Following successfully completed exploratory Phase 2A clinical development, VistaGen is preparing for Phase 2B clinical development of PH10 as a potential stand-alone, rapid-onset treatment for MDD.
VistaGen Therapeutics is a biopharmaceutical company committed to developing and commercializing innovative medicines with the potential to go beyond the current standard of care for anxiety, depression, and other CNS disorders. Each of VistaGen's three drug candidates has a differentiated potential mechanism of action, has been well-tolerated in all clinical studies to date and has therapeutic potential in multiple CNS markets. For more information, please visit www.vistagen.com and connect with VistaGen on Twitter, LinkedIn and Facebook.
Forward Looking Statements
Various statements in this release are "forward-looking statements" concerning our future expectations, plans and prospects, including the potential for successful clinical development and commercialization of PH10 for depression disorders, including MDD. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties which could cause actual results to differ materially from those contemplated in these forward-looking statements, including the risks that: development and approval of PH10 may not be achieved in any market; the FDA or counterpart foreign regulatory authorities may decide that the results of the our PH10 clinical program are not sufficient for regulatory approval for treatment of MDD or any other depression-related disorder; development of PH10 may not be successful in any indication; success in nonclinical studies or in earlier-stage clinical trials may not be repeated or observed in future studies, which may not support further development or be sufficient to gain regulatory approval to market PH10; adverse events may be encountered at any stage of development that negatively impact further development. Other risks and uncertainties include, but are not limited to, issues related to: adverse healthcare reforms and changes of laws and regulations; general industry and market conditions; manufacturing and marketing risks, including risks related to the COVID-19 pandemic, which may include, but are not limited to, unavailability of or delays in delivery of raw materials for manufacture of PH10; inadequate and/or untimely supply of PH10 to meet demand; entry of competitive products; and other technical and unexpected hurdles in the development, manufacture and commercialization of PH10, as well as those risks more fully discussed in the section entitled "Risk Factors" in our most recent Annual Report on Form 10-K for the year ended March 31, 2020, and in our most recent Quarterly Report on Form 10-Q for the quarter and six months ended September 30, 2020, as well as discussions of potential risks, uncertainties and other important factors in our other filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.
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