Vistagen Expands PH80 Migraine Treatment Patents Globally

Vistagen, a clinical-stage neuroscience-focused biopharmaceutical company based in South San Francisco, Calif., has recently announced significant expansions in its global intellectual property portfolio. The company, traded on Nasdaq under the ticker VTGN, is focused on developing and commercializing innovative therapies for psychiatric and neurological disorders utilizing a nose-to-brain neurocircuitry approach. This expansion comes with the granting of multiple new patents for the use of PH80 in treating migraines.

PH80 is an investigational, hormone-free pherine nasal spray designed to provide rapid onset relief for vasomotor symptoms like hot flashes stemming from menopause. Beyond its primary focus, PH80 also shows potential in treating premenstrual dysphoric disorder, dysmenorrhea, and migraine.

The recently awarded patents enhance the protection already provided by previously granted U.S. Patent No. 11,419,881 and European Patent Office (EPO) Patent No. 3955933 for migraine treatment. These patents are expected to remain in effect until 2040, subject to patent term extensions in various countries. The new patents have been issued across several jurisdictions:

- Australia: IP Australia has issued a Notice of Allowance.
- Hong Kong: The Hong Kong Intellectual Property Department granted Patent No. 40068177.
- Japan: The Japan Patent Office issued Patent No. 7476229.
- Mexico: The Mexican Institute of Industrial Property has issued a Notice of Allowance.

PH80 operates on a unique neurocircuitry-focused mechanism of action (MOA) that differentiates it from existing treatment options for women's health. Unlike traditional treatments, PH80 does not require systemic absorption or direct neural activity in the brain to achieve its therapeutic effects. Instead, it works by activating the olfactory system's neurocircuitry to stimulate specific brain regions without requiring central nervous system uptake. This localized approach results in a favorable safety profile, as demonstrated in completed clinical trials.

Pherines, the class of drugs to which PH80 belongs, are synthetic neuroactive steroids designed for intranasal delivery. These drugs are both odorless and tasteless, and they employ a unique MOA that sets them apart from existing therapies. By rapidly activating the olfactory system's neural connections, pherines target specific brain regions involved in the psychiatric and neurological disorders being treated. This mode of action allows them to provide therapeutic benefits without systemic absorption, reducing the risk of adverse effects commonly associated with systemic treatments.

Vistagen, headquartered in South San Francisco, is dedicated to pioneering treatments for psychiatric and neurological disorders through its innovative approach that leverages nose-to-brain neurocircuitry. The company’s portfolio includes a range of pherine product candidates, each designed to activate chemosensory neurons in the nasal cavity, impacting the olfactory system and brain neurocircuitry. The safety profiles of these candidates have consistently been positive across all clinical studies conducted so far.

In addition to its pherine nasal sprays, Vistagen's neuroscience pipeline features an oral prodrug aimed at modulating NMDA receptor activity. This prodrug shows promise in treating various neurological conditions, including levodopa-induced dyskinesia associated with Parkinson’s disease therapy and neuropathic pain.

Vistagen remains committed to developing novel, differentiated treatments that set new standards of care for individuals living with anxiety, depression, and other neurological disorders.