VistaGen and AffaMed complete regulatory submissions for Phase III SAD trial
pharmafile | April 13, 2022 | News story | Research and Development |
VistaGen and AffaMed have announced the completion of key regulatory preparations to initiate PALISADE global, a Phase III clinical trial to evaluate the efficacy, safety, and tolerability of VistaGen’s social anxiety disorder (SAD) treatment.
VistaGen’s PH94B is inidicated for the acute treatment of anxiety in adults with SAD, in the US and China. The main aim of PALISADE Global is to support potential commercialisation of PH94B in China, and other markets outside of the US.
PH94B is a first-in-class, rapid-onset pherine nasal spray. Pherines are odourless, synthetic neuroactive steroids that bind to distinct receptors on chemosensory cells in the nasal passages, and can impact the limbic amygdala without systemic uptake. It is designed to be administered intranasally at microgram doses, and the unique potential mechanism of action (MOA) of PH94B is fundamentally different from all current anti-anxiety medications, including benzodiazepines.
“We are very pleased with the substantial progress that our teams have made toward initiating PALISADE Global in two of the world’s largest pharmaceutical markets,” said Shawn Singh, CEOof VistaGen. “AffaMed’s clearance from the NMPA affirms our belief that AffaMed is the right partner for PH94B in China, and we remain confident in our collaboration as we advance this important late-stage clinical program for PH94B for the acute treatment of anxiety in adults with SAD. VistaGen remains committed to transforming the treatment of anxiety disorders for the millions of individuals worldwide who need better, safer, and faster-acting therapeutics in their journey toward mental health wellness.”
“NMPA’s clearance to begin the PALISADE Global Phase III trial is a tremendous milestone in advancing our product portfolio targeting neurological and psychiatric indications. I’m very proud of the dedication of our teams to bring forward a new treatment option for the rapidly growing number of individuals in China, South Korea, and Southeast Asia living with SAD,” said Dr Dayao Zhao, CEO of AffaMed. “We appreciate VistaGen’s essential work in the US under its PH94B IND application with the FDA. We thank the NMPA for recognizing the importance of this Phase III study and rapidly expediting the approval of our CTA. We look forward to dosing participants later this year.”