Virpax Pharmaceuticals, Inc. accomplished significant milestones related to its pipeline of product candidates as of the end of 2021. "I believe that Virpax has made considerable progress this past year toward our stated objectives," remarked the Chairman and CEO of Virpax. "These achievements include accelerated development of our existing product candidates, expanding our pipeline of product candidates, and leveraging grants where appropriate. We recently announced that we expect to initiate our initial human trial for Epoladerm™ in the second quarter of 2022."
"Virpax initially focused strictly on pain product candidates. However, our proprietary Molecular Envelope Technology ('MET') delivery platform licensed from Monomeric, Ltd. has enabled the development of product candidates for central nervous system ('CNS') and antiviral indications. In late 2021, we advanced the development of AnQlar™, a prophylactic, over-the-counter ('OTC') antiviral product candidate formulated to prevent the spread of respiratory infections such as flu, SARS-CoV-2, and rhinovirus. We added VRP324, which is an intranasally delivered cannabidiol ('CBD') formulation for the management of epilepsy in adults and children. Our Envelta™ IND-enabling studies, completed by the National Center for Advancing Translational Sciences ('NCATS') as part of our Cooperative Research and Development Agreement, determined that the MET intranasal delivery formulation bypasses the liver, which we believe reduces drug-drug interaction concerns for medications using this technology."
"On the corporate front, we strengthened our Board by appointing two new members who bring expertise in commercialization and financial strategy. Additionally, in 2021, we raised approximately $58 million in total gross proceeds from our initial public offering and an approved follow-on public offering. These funds are being utilized for research and development activities of our product candidates. We are on track to add milestones in 2022, and I remain confident that we have the significant financial strength to continue advancing our pipeline," said the CEO.
Epoladerm™
Epoladerm is a diclofenac topical spray film product that is being developed for pain related to osteoarthritis of the knee. Virpax recently announced the success of a Charles River Laboratories single-dose toxicology and pharmacokinetic study of dermal administration of Epoladerm in minipigs as part of the necessary Investigational New Drug Application ('IND') enabling trials. Single-dose transdermal delivery of Epoladerm was well-tolerated in all minipigs. There were no treatment-related clinical observations, changes in body weight, or dermal irritation noted. The maximum plasma concentration (Cmax) was reached at 4 hours post-dose, and concentrations of plasma Epoladerm remained at 24 hours post-dose for all animals.
Upon completion of all the necessary IND-enabling studies and subsequent review by the FDA, Virpax expects to conduct a Phase 1 study to assess the overall bioavailability and pharmacokinetics of Epoladerm™. Virpax recently announced the execution of a clinical trial agreement with Alta Sciences Company, Inc., to conduct this study in Canada. Virpax expects enrollment of the first patient by early second quarter of 2022.
Probudur™
Probudur is an injectable bupivacaine liposomal hydrogel for postoperative pain management which Virpax believes has improved onset and extended duration of action compared to existing treatment options. Additional preclinical trials are being conducted with Lipocure, the product developer, to improve formulation to potentially enhance manufacturing efficiencies, extend duration, and broaden patent protection. Once completed, we intend to perform seven preclinical animal studies as part of required FDA IND-enabling trials.
Envelta™
Envelta is an endogenous enkephalin intranasal spray for acute and chronic pain, including pain related to cancer. This product utilizes Nanomeric's MET platform technology which Virpax licensed to deliver the endogenous enkephalin formulation through an intranasal route, allowing the enkephalin to penetrate the blood-brain barrier while bypassing the liver. This product candidate is being funded through an in-kind CRADA with the NCATS.
Virpax recently reported that under this CRADA, the National Institutes of Health has awarded several contracts to support the research, development, and manufacturing of Envelta. These contracts aim to assist 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 preclinical efficacy studies and has acquired a device to be used with the manufactured GMP drug product for preclinical and clinical studies. The NIH has also engaged a firm to produce Leu-enkephalin ('L-ENK'), the active ingredient in Envelta, and a company to manufacture the MET carrier that delivers L-ENK to the brain to quickly alleviate pain.
AnQlar™
AnQlar (formerly MMS019) is a high-density intranasal molecular masking spray being developed as an antiviral OTC product for protection against respiratory infections such as SARS-CoV-2 and flu, which Virpax expects will be used as an adjunct to barrier-based personal protective equipment. Virpax recently reported a manufacturing and supply agreement with Seqens to provide AnQlar for both clinical studies and the long-term commercial supply of AnQlar.
Additionally, Virpax engaged with Sinclair Research to initiate IND-enabling studies for AnQlar. The Company anticipates that these preclinical animal studies will begin in mid-2022.
VRP324
Virpax has acquired the exclusive worldwide rights from Nanomerics to use its MET platform for the nasal delivery of CBD for the management of epilepsy in children (a rare pediatric condition) and adults.
Under this agreement, Virpax has the global rights to develop, manufacture, market, and sell VRP324, the first investigational formulation delivered through the nasal route to enhance CBD
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