VistaGen Therapeutics Inc (NASDAQ: VTGN) has reported financial results for its fiscal Q1 2023 for the quarter ending June 230, 2022, and offered a corporate update.
VistaGen developing PH94B for management of social anxiety disorder
CEO Shawn Singh said, “We remain steadfast in our commitment to change the trajectory of mental health care for millions of people affected by anxiety and depression disorders. While we examine the results of our PALISADE-1 Phase 3 study in social anxiety disorder, we have paused enrollment in our PALISADE-2 Phase 3 study and have engaged an independent biostatistician to conduct an interim analysis of data collected to date. We then plan to meet with the FDA to pursue a consensus path forward for further Phase 3 development of PH94B in social anxiety disorder.”
The company still has faith that PH94B will be beneficial to people with social anxiety disorder. Preliminary results from a cohort of over 200 patients in the PALISADE open-label safety trial who have finished three months of acute, as-needed PH94B usage are also encouraging. The Liebowitz Social Anxiety Scale (LSAS), which has long served as the medical gold standard for patient examination of social anxiety disorder, suggests that recurrent acute, as-needed usage of PH94B over a prolonged period of time may gradually lessen signs of social anxiety disorder.
The company deferred a significant part of its DNA enabling activities and, as a result, reduced its expected cash requirements for operations over the coming years.
PH94B didn’t attain primary efficacy in the PALISADE-1 study
During the quarter, the company released PALISADE-1 Phase 3 study results in which PH94B didn’t attain the primary efficacy endpoint. VistaGen continues to assess the results of the study. Min response to the findings, the company has halted enrolment in PALISADE-2, a third phase replicating the clinical study in the PALISADE clinical development program, as a third-party biostatistician carried out an interim analysis of available findings from PALISADE-2. Despite PALISADE-1 not meeting the primary efficacy endpoint, PH94B showed a favorable tolerability profile.