Vistagen has announced that the Phase 3 PALISADE-2 public speaking challenge trial of PH94B fasedienol nasal spray in subjects with social anxiety disorder met its primary and secondary endpoints. The company announced the initiation of PALISADE-2 in September 2021 and then paused the trial in mid-2022 after PALISADE-1 failed to meet its primary endpoint. The trial was expected to enroll 208 participants; however, only 141 were enrolled.
In September 2022, Vistagen announced that it was re-starting PALISADE-2; however, the study record shows a completion date of August 16, 2022, and the company now says, “The total enrollment reflects the pause in enrollment after receiving top-line results from PALISADE-1 to allow for independent third-party biostatisticians to conduct an interim analysis of the 141 patients randomized in the trial up to the date of the pause. Although the results of the independent interim analysis indicated that continuation of PALISADE-2 would not be futile, Vistagen determined the best course of action was to close the PALISADE-2 study given the expense, time and methodological complexities involved in resuming PALISADE-2.”
Earlier this year, the company announced results from a Phase 3 open-label safety study of PH94B that was said to be “closed early due to business reasons.” Vistagen initially acquired the rights to PH94B for SAD from Pherin Pharmaceuticals in 2018, and in December 2022, the company announced that it would acquire Pherin outright.
Vistagen CEO Shawn Singh commented, “We are thrilled that these compelling top-line results from the Phase 3 PALISADE-2 trial confirm what was seen in the Phase 2 studies in social anxiety disorder and highlight the potential for fasedienol, with its novel and unique proposed mechanism of action, to transform what is possible for more than 25 million people living with social anxiety in the US and millions more affected worldwide. As a new class of medicines, our pherine nasal spray pipeline holds the potential to transform the treatment landscape across numerous therapeutic areas. At the head of that class, fasedienol’s potential, as demonstrated in this Phase 3 trial, sets the stage for the first fundamentally new class of medicine for individuals living with SAD in more than 20 years.”
Read the Vistagen press release.
