Vistagen Reports New Preclinical Data Supporting Itruvone (PH10) Nasal Spray’s Potential Antidepressant Activity via Peripheral Nasal Neurons without Entry into the Brain
Preclinical study of radiolabeled intranasal itruvone in laboratory rats further validates itruvone’s potential to treat major depressive disorder (MDD) without systemic absorption
These new data further support the proposed mechanism of action of itruvone nasal spray as involving binding to receptors of peripheral chemosensory neurons in the nasal cavity, but not to neuronal receptors in the CNS, and thereby limiting transport of molecules to the circulatory system and minimizing potential systemic exposure.
“Itruvone’s unique mechanism of action is further demonstrated in this new carbon-labeled study,” said
Vistagen recently reported that itruvone is now staged for potential Phase 2B clinical development in the
About Itruvone (PH10)
Itruvone (PH10) is an investigational pherine nasal spray designed with a potential mechanism of action (MOA) that is fundamentally differentiated from the MOA of all currently approved treatments for depression disorders. Itruvone is administered at microgram-level doses and is designed to engage and activate chemosensory neurons in the nasal cavity connected to neural circuits in the brain that produce antidepressant effects. Specifically, itruvone’s proposed MOA involves binding to receptors of chemosensory neurons in the nasal cavity that regulate the olfactory-amygdala neural circuits believed to increase the activity of the limbic-hypothalamic sympathetic nervous system and increase the release of catecholamines. Importantly, unlike all currently approved oral antidepressants and ketamine-based therapy (KBT), including both intravenous ketamine and intranasal ketamine, we believe itruvone does not require systemic absorption or brain penetration to produce antidepressant effects, while avoiding side effects and safety concerns potentially associated with KBT and longer acting oral antidepressants. The FDA has granted Fast Track designation for the development of itruvone as a potential treatment for major depressive disorder.
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 the treatment of anxiety, depression and multiple CNS disorders. Vistagen’s pipeline includes six clinical-stage product candidates, including fasedienol (PH94B), itruvone (PH10), PH15, PH80, and PH284, each an investigational agent belonging to a new class of drugs known as pherines, as well as AV-101, which is an oral prodrug antagonist of the N-methyl-D-aspartate receptor (NMDAR). Pherines are administered as low microgram dose level nasal sprays and are designed with a novel mechanism of action that activates chemosensory neurons in the nasal cavity and can beneficially impact key neural circuits in the brain without systemic uptake or direct activity on CNS neurons in the brain. 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 developments may differ materially from those projected or implied in these forward-looking statements. Among other things, there can be no guarantee that any of Vistagen’s drug candidates, including itruvone, will successfully complete future clinical trials, receive regulatory approval or be commercially successful or that future studies will replicate results from prior non-clinical and/or clinical studies for any of Vistagen’s drug candidates. Other factors that may cause such a difference include, without limitation, risks and uncertainties relating to securing sufficient financing or third-party collaborative support to launch, conduct and complete clinical development and commercialization of itruvone or any of the Company's other product candidates; delays in launching, conducting and/or completing ongoing and/or planned clinical trials of itruvone or any of the Company’s other product candidates; fluctuating costs of materials and other resources required to conduct the Company’s ongoing and/or planned clinical and non-clinical trials; the scope of protection provided by the
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