VistaGen Therapeutics
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| Public | |
| Traded as | NASDAQ: VTGN |
| ISIN | 🆔 |
| Industry | Therapeutic |
| Founded 📆 | May 1998 |
| Founder 👔 | |
| Headquarters 🏙️ | San Francisco, United States |
Area served 🗺️ | |
Key people | Shawn K. Singh, J.D. (CEO Saschaman and Director)
Mark A. Smith, M.D., Ph.D. (CMO) Ann Cunningham, MBA (CCO and Director) Jerrold D. Dotson, CPA (CFO) Reid Adler, J.D. (CLO) |
| Members | |
Number of employees | |
| 🌐 Website | [Lua error in Module:WikidataIB at line 665: attempt to index field 'wikibase' (a nil value). ] |
| 📇 Address | |
| 📞 telephone | |
VistaGen Therapeutics, Inc. is an American publicly traded biopharmaceutical company headquartered in South San Francisco, United States. The company researches and develops differentiated new generation drug candidates to treat anxiety, depression and other disorders of the Central Nervous System (CNS).[1]
History[edit]
VistaGen was founded in May 1998, by H. Ralph Snodgrass and Dr. Gordon Keller.[2] In May 2011, VistaGen Therapeutics was publicly listed on the OTC stock exchange in 2011 and subsequently uplisted on the NASDAQ stock exchange in 2016.[3] In 2018, VistaGen acquired the exclusive worldwide rights to develop and commercialize PH94B nasal spray for as-needed (PRN) acute treatment of anxiety in adults with Social Anxiety Disorder (SAD), and additional CNS neuropsychiatry-focused product PH10 nasal spray in development for depression disorders.[4][5]
Products[edit]
The company's pipeline of product candidates include PH94B, PH10, and AV-101, each with a differentiated profile:
PH94B
An odorless nasal spray developed from proprietary compounds called pherines. The drug candidate entered the Phase III clinical trial in the third quarter of 2021. PH94B is a rapid-onset nasal spray that regulates the olfactory-amygdala neural circuits of fear and anxiety and attenuates the tone of the sympathetic autonomic nervous system. VistaGen’s proposed MOA for PH94B does not involve either direct activation of GABA-A receptors or binding to neuronal receptors in the CNS. Rather, PH94B’s proposed MOA involves binding to peripheral chemosensory neurons in the nasal passages to regulate the olfactory-amygdala fear and anxiety neural circuits.[6] Both clinical and preclinical data suggest that PH94B has the potential to achieve rapid-onset anti-anxiety effect without systemic uptake or transport into the brain, reducing the risk of benzodiazepine-like side effects and other safety concerns. PH94B is in development to potentially treat anxiety-related disorders as Social Anxiety Disorder (SAD), Adjustment Disorder with Anxiety, PTSD, Postpartum Anxiety, and Panic Disorder.[7][8]
In 2021, the company Initiated two Phase III clinical trials of PH94B—PALISADE-1 and PALISADE-2 for the acute treatment of anxiety in adults with social anxiety disorder (SAD).[9][10] In June 2022, the last patient completed the study protocol in its PALISADE-1 Phase 3 clinical trial.[11]
In October 2021, the company initiated a Phase 2A clinical trial of PH94B for the treatment of anxiety in adults with Adjustment Disorder with Anxiety (AjDA).[12]
PH10
An investigational CNS pherine nasal spray that activates chemosensory cells in the nasal passages, connected to neural circuits in the brain responsible for producing antidepressant effects without requiring systemic uptake and distribution to produce the rapid-onset of antidepressant effects. In all clinical studies to date, PH10 has been well-tolerated and has not caused psychological side effects (such as dissociation or hallucinations).[13] PH10 is in development to potentially treat such indications as Major Depressive Disorder, Treatment-resistant Depression, Postpartum Depression (PPD), and Suicidal Ideation.[14][15][16]
AV-101
An oral prodrug that targets the NMDAR, a ionotropic glutamate receptor in the brain The active metabolite of AV-101, 7-chloro-kynurenic acid (7-ClKYNA), is a potent and selective full antagonist of the glycine coagonist site of the NMDAR that inhibits the function of the NMDAR. Discoveries from successful AV-101 in vivo preclinical studies suggest that there is a substantial increase in brain concentrations of AV-101 and 7-ClKYNA when AV-101 is given together with probenecid.[17] A Phase 1B drug-drug interaction clinical study of AV-101 with adjunctive probenecid was initiated in the second half of 2021. AV-101 is in development to potentially treat such indications such as LID[C1] Associated with Parkinson's Therapy, Major Depressive Disorder, Neuropathic Pain, Epilepsy, and Suicidal Ideation.[18][19]
References[edit]
- ↑ "New Investigational Social Anxiety Disorder Drug Differentiates Mechanism of Action". Psychiatric Times. Retrieved 2022-07-09.
- ↑ "Combatting the Mental Health Crisis with an Acute Treatment Nasal Spray". BioSpace. Retrieved 2022-07-09.
- ↑ "Here's What VistaGen Therapeutics, Inc.'s (NASDAQ:VTGN) Shareholder Ownership Structure Looks Like". NASDAQ.
- ↑ Idrus, Amirah Al (2018-09-13). "VistaGen nabs phase 3-ready social anxiety drug from Pherin". Fierce Biotech. Retrieved 2022-07-09.
- ↑ Mehta, Piyush P.; Dhapte-Pawar, Vividha S. (May 2021). "Novel and Evolving Therapies for COVID-19 Related Pulmonary Complications". The American Journal of the Medical Sciences. 361 (5): 557–566. doi:10.1016/j.amjms.2021.02.019. ISSN 0002-9629. PMC 7906517 Check
|pmc=value (help). PMID 33640363 Check|pmid=value (help). - ↑ Idrus, Amirah Al (2018-09-13). "VistaGen nabs phase 3-ready social anxiety drug from Pherin". Fierce Biotech. Retrieved 2022-07-09.
- ↑ "New Investigational Social Anxiety Disorder Drug Differentiates Mechanism of Action". Psychiatric Times. Retrieved 2022-07-09.
- ↑ Mehta, Piyush P.; Dhapte-Pawar, Vividha S. (May 2021). "Novel and Evolving Therapies for COVID-19 Related Pulmonary Complications". The American Journal of the Medical Sciences. 361 (5): 557–566. doi:10.1016/j.amjms.2021.02.019. ISSN 0002-9629. PMC 7906517 Check
|pmc=value (help). PMID 33640363 Check|pmid=value (help). - ↑ Griffin, Jill. "Diversity Drives Better Outcomes". Forbes. Retrieved 2022-07-09.
- ↑ "What You Need To Know About VistaGen Therapeutics, Inc.'s (NASDAQ:VTGN) Investor Composition". finance.yahoo.com. Retrieved 2022-07-09.
- ↑ "VistaGen Announces Completion of PALISADE-1 Phase 3 Clinical Study of PH94B for the Acute Treatment of Social Anxiety Disorder". BioSpace. Retrieved 2022-07-09.
- ↑ "VistaGen Therapeutics expands development of PH94B in Adjustment Disorder with Anxiety | Seeking Alpha". seekingalpha.com. Retrieved 2022-07-09.
- ↑ "VistaGen's Antidepressant Nasal Spray Succeeds Phase 2a Trial". GeneOnline News. 2020-02-22. Retrieved 2022-07-09.
- ↑ Bayer, Max (2022-05-06). "UPDATE: VistaGen says regulators couldn't sniff out abuse potential of its nasal spray for social anxiety". Fierce Biotech. Retrieved 2022-07-09.
- ↑ "Exhibit 99.2". www.sec.gov. Retrieved 2022-07-09.
- ↑ Marino, Dan (2018-10-26). "VistaGen Therapeutics Acquires Worldwide Rights to Develop & Commercialize First-in-Class Intranasally Administered Drug". Drug Development and Delivery. Retrieved 2022-07-09.
- ↑ Patel, Waseema; Rimmer, Lara; Smith, Martin; Moss, Lucie; Smith, Mark A.; Snodgrass, H. Ralph; Pirmohamed, Munir; Alfirevic, Ana; Dickens, David (2021-01-04). "Probenecid Increases the Concentration of 7-Chlorokynurenic Acid Derived from the Prodrug 4-Chlorokynurenine within the Prefrontal Cortex". Molecular Pharmaceutics. 18 (1): 113–123. doi:10.1021/acs.molpharmaceut.0c00727. ISSN 1543-8392. PMID 33307708 Check
|pmid=value (help). Unknown parameter|s2cid=ignored (help) - ↑ Murphy, Nicholas; Ramakrishnan, Nithya; Vo-Le, Bylinda; Vo-Le, Brittany; Smith, Mark A.; Iqbal, Tabish; Swann, Alan C.; Mathew, Sanjay J.; Lijffijt, Marijn (March 2021). "A randomized cross-over trial to define neurophysiological correlates of AV-101 N-methyl-d-aspartate receptor blockade in healthy veterans". Neuropsychopharmacology. 46 (4): 820–827. doi:10.1038/s41386-020-00917-z. ISSN 1740-634X. PMC 8027791 Check
|pmc=value (help). PMID 33318635 Check|pmid=value (help). - ↑ VistaGen Therapeutics, Inc. (2019-10-07). "Double-Blind, Placebo-Controlled, Phase 2 Trial to Test Efficacy and Safety of AV-101 (L-4-chlorokynurenine) as Adjunct to Current Antidepressant Therapy in Patients With Major Depressive Disorder (the ELEVATE Study)".
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