In an exclusive interview with The Fly, the company's CEO Shawn Singh talked about VistaGen's PH10 and PH94B studies: "We have two novel, first-in-class neuroactive
nasal spray product candidates, each, like AV-101, with an exceptional safety profile in studies to date and each with therapeutic potential in multiple large and growing mental health markets where current treatments are inadequate at meeting the needs of millions of patients.
The increase in research and development expense is primarily related to the continued progress of ELEVATE, the Company's Phase 2 clinical study evaluating efficacy and safety of AV-101, its novel oral NMDA (N-methyl-D-aspartate) receptor glycine site antagonist, as an add-on treatment (together with an FDA-approved oral antidepressant) for adults with major depressive disorder (MDD), several preclinical studies, including studies supporting AV-101's potential for treating neuropathic pain (NP) and levodopa-induced dyskinesia (LID) in patients with Parkinson's disease, and manufacturing activities involving AV-101 and the Company's two novel, clinical-stage neuroactive
nasal spray candidates, PH94B for social anxiety disorder (SAD) and PH10 for MDD.
Scientists at the Uskudar University, in Istanbul, noted that microorganisms in our digestive system are capable of producing and delivering neuroactive
substances such as serotonin, and preclinical research in rodents suggested certain probiotics could have antidepressant and anxiolytic activities.
This link further supports Axial Biotherapeutics' foundational scientific rationale, suggesting that the gut microbiome regulates behavior in mice via the production of neuroactive
Such mechanisms may include alterations in microbial composition, immune activation, vagus nerve signaling, alterations in tryptophan metabolism, production of specific microbial neuroactive
metabolites, and bacterial cell wall sugars.
insecticides: Targets, selectivity, resistance, and secondary effects.
Acute and chronic effects of electroconvulsive therapy on neuroactive
steroids in patients with major depressive disorder.
The team behind the research studied the genomes of more than 500 types of gut bacteria and analysed their ability to produce a range of neuroactive
compounds - chemicals shown to affect how the brain works.
In anxiety and depression, many studies have reported that neuroactive
steroids and steroidal hormones such as testosterone and estrogen in brain structures such as hippocampus and amygdala affect neural excitability and are associated with mood disorders (19,25-27).
The team behind the research studied the genomes of more than 500 types of gut bacteria and analyzed their ability to produce a set of neuroactive
compounds -- chemicals shown to affect brain function.
KEGG pathway analysis identified 2 enriched pathways, hsa04080: Neuroactive
ligand-receptor interaction (GRM8, DRD5, GRIN3A, FSHR) and hsa04024: cAMP signaling pathway (DRD5, GRIN3A, FSHR) (Table 4).