Nuformix Regulatory News (NFX)

Nuformix and VistaGen Announce Agreement to Develop Novel Patentable Cocrystal Forms of AV-101 for Treatment of Multiple CNS Conditions

Novel Cocrystal Form of AV-101 Administered with Probenecid 

May Have Superior Delivery, an Enhanced Therapeutic Profile

 and Additional Intellectual Property Protection.

Cambridge, UK - 27 May 2020: Nuformix plc (LSE:NFX) ("Nuformix" or "the Company"), the pharmaceutical development company focused on unlocking the therapeutic potential and value of known drugs and VistaGen Therapeutics (NASDAQ:VTGN), a clinical-stage biopharmaceutical company developing new generation medicines for anxiety, depression and other central nervous system "CNS" diseases and disorders with high unmet need, today announced their agreement to develop novel cocrystal-based formulations of VistaGen's CNS product candidates. Under the terms of the agreement, Nuformix and VistaGen will initially apply Nuformix's proprietary technology platform to develop patentable new crystalline forms of AV-101 that may offer superior delivery, an enhanced therapeutic profile and additional intellectual property protection. If successful, Nuformix and VistaGen will consider opportunities to extend the collaboration to other CNS therapeutic candidates with a view to unlocking additional therapeutic and commercial opportunities.

Dr Dan Gooding, Chief Executive Officer Nuformix, said:

"We're very pleased to announce this agreement with VistaGen and the opportunity to collaborate in CNS therapeutics. VistaGen and Nuformix share similar objectives in the development of new therapies and we look forward to making an important contribution to VistaGen's comprehensive AV-101 programme and developing the relationship further."

H. Ralph Snodgrass, PhD, VistaGen's President and Chief Scientific Officer, said: "Nuformix has a successful track record of using cocrystal technology to re-engineer the crystalline form of small molecule drugs for their own development and for select partners. Their team is not only highly experienced, but also scientifically creative. We look forward to a productive collaboration."

AV-101 is VistaGen's oral NMDAR (N-methyl-D-aspartate receptor) glycine site antagonist, in development in combination with probenecid, a safe and well-known oral drug used to treat gout and to increase the therapeutic benefit of numerous antibacterial, anticancer and antiviral drugs. Recently reported preclinical data suggest that there is a substantially increased brain concentration of AV-101 prodrug (4-Cl-KYN) and its active metabolite, 7-chlorokynurenic acid (7-Cl-KYNA), when given together with probenecid. With its exceptionally few side effects and excellent safety profile in all clinical studies to date, AV-101, together with probenecid, has potential to be a new generation oral treatment for chronic neuropathic pain, epilepsy, levodopa-induced dyskinesia associated with Parkinson's disease therapy, major depressive disorder, and suicidal ideation.

About AV-101

AV-101 (4-Cl-KYN) targets the NMDAR (N-methyl-D-aspartate receptor), an ionotropic glutamate receptor in the brain. Abnormal NMDAR function is associated with numerous CNS diseases and disorders. AV-101 is an oral prodrug of 7-chlorokynurenic acid (7-Cl-KYNA), which is a potent and selective full antagonist of the glycine co-agonist site of the NMDAR that inhibits the function of the NMDAR. Unlike ketamine and many other NMDAR antagonists, 7-Cl-KYNA is not an ion channel blocker. In all studies to date, AV-101 has exhibited no dissociative or hallucinogenic psychological side effects or safety concerns similar to those that may be caused by amantadine, esketamine and ketamine. With its exceptionally few side effects and excellent safety profile, AV-101 has potential to be an oral new generation treatment for multiple large-market CNS indications where current treatments are inadequate to meet high unmet patient needs. The FDA has granted Fast Track designation for development of AV-101 as both a potential adjunctive treatment for MDD and as a non-opioid treatment for neuropathic pain.

About Cocrystals

Pharmaceutical cocrystals are materials composed of two or more different molecules, usually an active pharmaceutical ingredient together with a "co-former" molecule. Cocrystals can be engineered to enhance the bioavailability, pharmacokinetics, stability and manufacturing of drug products.

About Nuformix

Nuformix is a pharmaceutical development company focused on unlocking the therapeutic potential and value of known drugs. Nuformix risk-mitigated development strategy has resulted in a pipeline of discoveries through which it has developed and patented novel forms of approved small molecules.

Nuformix is targeting high-value unmet needs via drug repurposing with a lead programme in fibrosis (NXP002). Nuformix plc shares are traded on the London Stock Exchange's Official List under the ticker: NFX. For more information please visit www.nuformix.com.

About VistaGen

VistaGen Therapeutics is a multi-asset, clinical-stage biopharmaceutical company developing new generation medicines for anxiety, depression and certain CNS diseases and disorders where current treatments are inadequate, resulting in high unmet need. VistaGen's pipeline is focused on three clinical-stage CNS drug candidates, each with a differentiated mechanism of action, an exceptional safety profile, and therapeutic potential in multiple large and growing CNS markets. For more information, please visit www.vistagen.com and connect with VistaGen on Twitter, LinkedIn and Facebook.

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