VistaGen Therapeutics said that it has initiated the PALISADE-2 Phase 3 clinical trial of its PH94B aloradine nasal spray for the treatment of social anxiety disorder (SAD). The company initiated the PALISADE-1 trial of PH94B for SAD in May 2021. Topline results from that trial are expected in mid-2022, with results from the PALISADE-2 trial expected later that year.
PALISADE-2, which will be essentially the same format as PALISADE-1, is expected to enroll 208 patients. Both of the Phase 3 trials include a public speaking challenge that was used in a Phase 2 study of PH94B for SAD initiated by Pherin Pharmaceuticals in 2008. VistaGen licensed the nasal spray from Pherin in 2018.
VistaGen CEO Shawn Singh commented, “Following the successful initiation of PALISADE-1 last quarter, we are excited to be further advancing our PALISADE Phase 3 Program this quarter with the initiation of PALISADE-2, an essential next step in our efforts to further demonstrate the reduction in anxiety observed in PH94B’s Phase 2 clinical trials to date. If successful, these Phase 3 clinical trials, along with the other planned clinical trials in our PALISADE Phase 3 Program, are intended to support the potential submission of a New Drug Application to the FDA in 2023. Our team continues to make progress towards that core objective. PH94B has the potential to be a life-changing acute, as-needed treatment of anxiety for adults with SAD, similar to how a rescue inhaler is used on demand to acutely treat an asthma attack.”
Read the VistaGen Therapeutics press release.
