Virpax Pharmaceuticals Inc. (NASDAQ: VRPX) said on Tuesday it received a written pre-IND (investigational new drug) response from the U.S. FDA (Food and Drug Administration) for MMS019 that supports further research on its application as an intranasal protective that restricts transmission of viruses to others.
Virpax to seek an NDA for MMS019
The Pennsylvania-based company said it will now seek an NDA (new drug application) for its high-density molecular masking spray as a once-daily anti-viral barrier product. The U.S. drug regulator also stipulates Virpax to pursue an NDA.
The announcement comes after Virpax completed in-vitro, ex-vivo, and in-vivo trials for MMS019 that demonstrated the candidate drug to hold a significant inhibitory effect on replication of viruses, including influenza and SARS-CoV-2. The studies didn’t report any adverse effects.
Last week, Virpax reported its financial results for the second quarter. Shares of the pharmaceutical company are up about 280% on Tuesday. Virpax debuted on the Nasdaq Stock Exchange earlier this year in February at a per-share price of $6.53 and is exchanging hands at $13 a share at the time of writing.
CEO Anthony Mack’s remarks
Virpax has now partnered with Syneos Health to design a clinical trial based on an efficient timeline to move ahead with its experimental product. In the press release on Tuesday, CEO Anthony Mack said:
“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
