Virpax Pharmaceuticals said that it is encouraged by the FDA response to its IND for MMS019 “high-density molecular masking spray” which the company is developing as an anti-viral barrier. According to Virpax, the company now intends to begin clinical development with the goal of submitting an NDA for MMS019 to the FDA’s Office of Non-Prescription Drugs. The company also said that it has hired CRO Syneos Health to help design the clinical trial.
The company licensed MMS019 from Nanomerics in August 2020. The Virpax announcement describes MMS019 as “based on a type of nanotechnology that enables the exclusive delivery of a metabolically labile peptide drug into the brain on intranasal delivery.” In April 2021, Virpax announced that studies of intranasal MMS019 inhibited viral replication of SARS-CoV-2 in mouse nasal passages.
Virpax Chairman and CEO Anthony P. Mack said, “We are very pleased with the response from the FDA. We believe that the initial pathway to move forward with the development of MMS019 has been clarified. The pre-IND meeting provides an opportunity for open communication between the sponsor and the FDA to discuss the IND development plan and to obtain the FDA’s guidance for clinical studies for the new drug candidate. As our development program proceeds, we will define the strategy for our drug-device combination product candidate, MMS019, for use in an over-the-counter setting as we look to support a consumer-friendly OTC indication.”
Read the Virpax Pharmaceuticals press release.
