VistaGen Therapeutics has acquired exclusive global rights to PH94B aloradine nasal spray, which Pherin Pharmaceuticals has been developing for the treatment of social anxiety disorder (SAD), the company said. A Phase 3 study of PH94B for SAD is planned for the first half of 2019.
Pherin received $2.25 million of unregistered common stock from VistaGen for the license and for an option for VistaGen to license “an additional CNS neuropsychiatry-focused product in Phase 2 development.” Pherin’s PH10 nasal spray is currently in Phase 2 development for the treatment of depression.
Pherin Executive VP Louis Monti said, “This agreement provides a meaningful opportunity to continue our clinical progress and advance our mission to bring novel treatment alternatives to the many individuals affected with SAD. We are confident VistaGen will build upon our earlier clinical studies, which provided impressive evidence of rapid (10-15 minutes) anxiety reduction for subjects with SAD. In all prior clinical studies, PH94B was well tolerated and there were no adverse events associated with nasal spray administration. Our prior clinical studies support the potential of PH94B to be a superior treatment alternative for SAD due to the demonstrated rapid onset of efficacy, route of administration, as-needed dosing convenience, and excellent safety profile compared to other existing therapeutic options which require chronic dosing and have concurrent side effects.”
VistaGen CEO Shawn Singh commented, “SAD affects nearly 15 million Americans. Currently, there is no FDA-approved treatment that provides rapid-acting relief, and sedatives used off-label carry with them the risk of addiction and other significant side effects and safety concerns. PH94B clinical data are compelling and support its potential to be a first-in-class, rapid-acting, self-administered, PRN treatment alternative, without sedation, risk of addiction or other safety concerns, for millions affected by SAD in the US and other major markets. This transaction not only expands and diversifies our CNS pipeline to include SAD, but also firmly complements our patent-protected, neuropsychiatry focus on MDD with AV-101 in our ongoing Phase 2 ELEVATE study.”
Read the VistaGen and Pherin press release.
