Disclaimer: VistaGen does not currently have an approved / commercialized product in their product pipeline and the efficacy of a treatment for patients with diseases and disorders involving CNS is not easy to measure in a clinical setting.
VistaGen Therapeutics (VTGN) is a clinical-stage biopharmaceutical company focused developing and commercializing product candidates for patients with diseases and disorders involving the central nervous system (CNS).
PH94B is a neuroactive nasal spray that has being successfully tested in the PALISADE-2 trial (phase 2) to treat social anxiety disorder (SAD) and received FDA fast track designation for treating SAD (social anxiety disorder).
VistaGen recently filed for patent protection for the platform for PH94B in AjD and is set to complete its acquisition of Pherin Pharmaceuticals for full ownership of intellectual property rights to PH94B.
The clinical research journey of H94B to date…
H94B Phase 1 Data demonstrated its well-tolerated, reduced autonomic biomarkers and increased EGNR
In a second Phase 2 Study demonstrated potential to be a novel, fast-acting treatment of anxiety in adults and met again all its primary efficacy endpoints:
It is a bit usual to do another Phase 2 study. I believe its driven by the difficulties to measure the efficacy for a disease involving the central nervous system (CNS) in clinical setting. I believe they knew the data of first phase 2 study would be not sufficient.
Now its in phase 3 but the road cotnties to be bumpy. At same point the trial was on hold until Independent biostatisticians recommend continuing Phase 3 trial without any changes after conducting interim analysis of 140 completed subjects. Healthy subject data reported that treatment significantly increased the electrogram response recorded from the nasal mucosa, while rapidly lowering heart rate, respiratory rate, and electrodermal activity consistent with decreased sympathetic nervous system activity.
Upcoming Catalyst: Read out Phase 2a data from its trial of PH94B as a treatment for adjustment disorder with anxiety (AjDA).
VistaGen is looking at other opportunities beyond Social Anxiety Disorder (SAD) for PH94B and running a Phase 2 study for adjustment disorder with anxiety (AjDA).
“Adjustment disorder with anxiety is an emotional or behavioral reaction considered excessive or disproportionate to a sudden change, stressful event or major life change, such as loss of work, divorce or health setback, occurring within three months of the stressor, and/or significantly impairing a person’s social, occupational and/or other important areas of functioning.”
A total of 40 patients will be randomized (11 drug to placebo). The study design features the use of the ADNM and IADQ, newly developed according to ICD-11 criteria for evaluation of AjDA. While both are validated, neither has been tested in placebo-controlled clinical trials. Both scales begin with a list of stressors (18 for ADNM and 9 for IADQ);a yes answer to any 1 stressor triggers a series of questions about the frequency and duration of a patient’s reaction to the stressor (ADNM) or quantifies symptoms in response to the stressor (IADQ).
In addition good news on the IP front:
These new filings are intended to provide a global exclusivity platform for PH94B in AjD, similar to the Company’s patent protection for PH94B for the treatment of social anxiety disorder (SAD), and for its other late-clinical stage product candidate, PH10, for the treatment of major depressive disorder (MDD).
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 it will host a conference call and webcast on Tuesday, February 7, 2023, at 2:00 p.m. Pacific Time (5:00 p.m. Eastern Time) to report financial results for its fiscal year 2023 third quarter ended December 31, 2022 and provide a corporate update.
Wondering if they provide any update tomorrow, conference call was announced on a very short notice.
“The company believes it is not yet advisable to make a decision about resuming PALISADE-2 before discussing its broader phase 3 development plan for PH94B with the FDA and before further assessing the potential impact of the proposed adjustments to the PALISADE-2 protocol in light of two recently completed public speaking challenge [social anxiety disorder] studies conducted by peers, each of which did not achieve its primary efficacy endpoint,”
No direct impact to the catalyst of this DD but market reacts sensitive to any negative news. Pre-Market down 20%.
PH94B (Adjustment Disorder with Anxiety) (Phase 2a): Top-line data due in 1Q 2023
Global PH94B (Social Anxiety Disorder) (Phase 3): Phase 3 trial discussions ongoing with FDA.
AV-101 (Major depressive disorder) (Phase 1b): Phase 1b trial to be completed in 1H 2023.
PH94B (Social Anxiety Disorder): Phase 3 restart preparations are underway after an independent interim analysis recommended the study to continue as planned, Trial protocol changes submitted to FDA on February 7, 2023.
Basically the FDA provided positive feedback on their phase 3 study design and the defined endpoints in that study. This is positive as the phase 3 will be the basis for the new drug application to the FDA.
