Virpax Pharmaceuticals said that the National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health has begun pre-clinical studies of Virpax’s Envelta intranasal enkephalin to support an IND submission. Virpax signed a cooperative research and development agreement with NCATS in August 2020. Envelta is delivered via a single use intranasal device that includes a cartridge filled with an intranasal formulation of nanoparticles loaded with enkephalin and a propellant.
In March 2020, Virpax announced that it had completed a successful pre-IND meeting with the FDA regarding the intranasal enkephalin (NES100), which it is developing for the treatment of acute and chronic pain. The company had also previously said that it intended to develop intranasal enkephalin for the treatment of PTSD.
Virpax Chairman and CEO Anthony P. Mack commented, “The commencement of these critical pre-clinical studies takes us one step closer to the clinic. Dr. Jeffrey Gudin, principal investigator and co-founder of Virpax, has been working in partnership with the NCATS since we announced the CRADA in August 2020. We believe that the NIH/NCATS collaborative agreement will facilitate maintaining momentum for our team in both our pre-clinical and future clinical development strategies.”
Read the Virpax Pharmaceuticals press release.