Virpax Pharmaceuticals (Nasdaq:VRPX) announced today that it completed all FDA-required preclinical studies for its Epoladerm product.
Berwyn, Pennsylvania-based Virpax designed its Epoladerm investigational pre-filled topical spray analgesic product for the non-addictive management of chronic pain associated with osteoarthritis (OA) of the knee. Its completed investigational new drug application (IND)-enabling studies included dermal toxicity, sensitization, irritation, phototoxicity and PK characteristics, according to a news release.
The company said it is drafting FDA IND submission documents for Epoladerm that include the preclinical studies, while the company has a clinical trial agreement with Altasciences to complete a first-in-human pilot study investigation Epoladerm. Virpax expects to enroll the first patient in the Canada-based study sometime this year, with results from the pilot study expected to be part of its IND application.
Virpax’s proprietary Epoladerm technology acts as an aerosol canister for the application of the spray film to the knee. The company touts the resulting film as thinner than a standard liquid bandage, with clear coating upon application to the knee, while it dries fast.
“Our internal research and development team, along with an extensive network of partners, has progressed Epoladerm through the IND-enabling studies,” Virpax Chairperson and CEO Anthony P. Mack said in the release. “We believe our clinical studies will demonstrate that Epoladerm, which utilizes our unique spray film technology, will be a more effective and easier-to-use treatment for OA of the knee than what is currently available. We anticipate rapid progress toward the completion of the clinical studies.”