Source – Vistagen Therapeutics
After facing a string of setbacks, Vistagen has experienced a remarkable turnaround as its social anxiety spray triumphs in a Phase III trial, igniting a surge in the company’s stock value.
The clinical study, named PALISADE-2, aimed to assess the effectiveness, safety, and tolerability of fasedienol, also referred to as PH94B—a nasal spray designed to aid adults with social anxiety disorder (SAD). Fasedienol surpassed the trial’s primary endpoint, exhibiting a statistically significant enhancement in the average distress score on a standardized scale during a public speaking challenge, in comparison to a placebo. This pivotal data was disclosed on August 7.
Furthermore, the trial achieved its secondary objective by demonstrating a statistically significant alteration in clinician-determined improvement between participants receiving fasedienol and those receiving a placebo. Vistagen also reported that fasedienol was well-tolerated and exhibited a favorable safety profile.
In response to this positive news, Vistagen’s stock price surged by an astonishing 1,272% from the previous market close, leaping from $1.68 per share to $24.70 as trading commenced on Monday. Although the stock’s trajectory has since stabilized somewhat, it reached $12.07 per share at 11 a.m. ET.
“We are thrilled that these compelling top-line results from the Phase III PALISADE-2 trial confirm what was seen in the Phase II 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 U.S. 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.”
– Shawn Singh, Chief Executive Officer of Vistagen
Vistagen is heralding this achievement as the “first positive Phase III study” of an investigational therapy for social anxiety disorder in the United States in over 15 years. However, this outcome was far from guaranteed, as the social anxiety asset had encountered numerous challenges in recent years.
Following the disappointment of two rival candidates for social anxiety disorder failing their Phase II trials, Vistagen temporarily halted its plans for PALISADE-2 and fasedienol, pending discussions with the FDA.
The company’s asset had previously faltered in a Phase III trial called PALISADE-1, which involved patients with SAD. In response to this setback, Vistagen engaged independent biostatisticians to conduct an interim analysis of PALISADE-2.
The biostatisticians gave Vistagen the green light to proceed with the study without making changes to the design, but Vistagen hesitated. The company subsequently revealed that a deeper analysis of the failed trial had prompted proposed modifications to PALISADE-2, aimed at addressing the issues that had possibly contributed to the disappointing results of the earlier study. External data then prompted fresh concerns about the potential impact of the protocol changes, leading to consultations with the FDA regarding the study’s design.
“Fasedienol demonstrated a rapid and very clinically meaningful reduction in SUDS score, indicating a single administration has the potential to reduce anxiety symptoms during an anxiety-provoking situation. A future Phase III study involving multiple administrations of fasedienol over several weeks on a patient-tailored, as-needed basis will build on the body of evidence now demonstrated in PALISADE-2 and multiple Phase II studies. Fasedienol could be an optimal treatment for social anxiety patients given its ability to be used acutely to reduce anxiety while helping to reduce SAD severity over time.”
– Dr. Michael R. Liebowitz, innovator of the Liebowitz Social Anxiety Scale, former Columbia University psychiatrist, director and founder of the Anxiety Disorders Clinic at the New York State Psychiatric Institute, and current Managing Director of The Medical Research Network LLC in New York City
While the trial was on hold, Vistagen released data in March from an open-label phase 3 study assessing the spray’s effectiveness in SAD patients. The company asserted that the data indicated the therapy’s safety and its potential to be effective on an as-needed basis.
Now, with the positive outcome of the Phase III trial, Vistagen has completed a full circle in its trial journey, marking a significant victory in the pursuit of addressing social anxiety disorder.
