Virpax Advances Envelta Development with NCATS Under CRADA Agreement

Virpax Pharmaceuticals

BERWYN, PA — Virpax Pharmaceuticals, Inc. announced that the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) recently awarded research and development contracts to support Good Manufacturing Practices (GMP) production of drug substance and drug product. as well as to support Good Laboratory Practices (GLP) toxicology, safety studies and preclinical efficacy studies. The NIH has contracted with a clinical research organization to conduct additional pre-clinical efficacy studies and procured a device to be used with the manufactured GMP drug product for preclinical and clinical studies. The NIH has also engaged a firm to manufacture Leu-enkephalin (L-ENK), the active ingredient in Envelta and a firm to manufacture the Molecular Envelope Technology (MET) that is used to carry the L-ENK to the brain to promptly suppress pain.

Envelta is Virpax’s endogenous enkephalin intranasal spray for acute and chronic pain, including pain associated with cancer. IND-enabling studies for Envelta are being performed under a Cooperative Research and Development Agreement (CRADA) with NCATS entered into by Virpax in August of 2020.

“We are encouraged with the progress that has been made under the CRADA with NCATS and the NIH Helping to End Addiction Long-term (HEAL) initiative, as we believe that it may help Virpax develop an effective and safe alternative to conventional opioids used by patients to manage acute and chronic pain. In October 2021, Virpax announced that a $1.87 million contract had been signed with Recro Pharma for the development, manufacturing, and stability studies of Envelta. Also, the NIH engaged Battelle to conduct Dose Range Finding Studies, with the first study in rats being completed on October 7th, 2021. A Dose Range Finding Study in dogs will start on November 10, 2021. With today’s announcement, we believe we are well on our way to completing the required IND-enabling studies for Envelta. Once completed, it is our intention to immediately submit our IND package to the FDA so that we may begin human trials,” commented Virpax’s Chairman & CEO Anthony P. Mack.

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