Therapy Areas: Respiratory
Multiple Contracts Awarded to Support the Development and Manufacturing of Envelta
10 November 2021 - - The National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health has awarded research and development contracts to US-based pain management, CNS disorders and anti-viral indications product candidates developer Virpax Pharmaceuticals, Inc. (NASDAQ: VRPX), to support Good Manufacturing Practices production of drug substance and drug product. as well as to support Good Laboratory Practices toxicology, safety studies and preclinical efficacy studies, the company said.

The NIH has contracted with a clinical research organization to conduct additional pre-clinical efficacy studies and procured a device to be used with the manufactured GMP drug product for preclinical and clinical studies.

The NIH has also engaged a firm to manufacture Leu-enkephalin (L-ENK), the active ingredient in Envelta and a firm to manufacture the Molecular Envelope Technology that is used to carry the L-ENK to the brain to promptly suppress pain.

Envelta is Virpax's endogenous enkephalin intranasal spray for acute and chronic pain, including pain associated with cancer.

IND-enabling studies for Envelta are being performed under a Cooperative Research and Development Agreement (CRADA) with NCATS entered into by Virpax in August of 2020.

Envelta is an investigational intranasal formulation intended to improve enkephalin transport to the brain. Enkephalin is a naturally occurring (endogenous) peptide that is not easily administered in its original form.

Envelta uses a preassembled device and cartridge to propel the enkephalin formulation through the nose to the brain by flowing along the olfactory nerve pathway.

The Molecular Envelope Technology is designed to protect the drug and help carry it to the brain, enabling it to cross the blood-brain barrier to suppress pain by binding to the delta-opioid receptors.

Envelta has demonstrated analgesic potential in animal models without developing opioid tolerance, withdrawal, respiratory depression, euphoria, or addiction associated with the use of morphine.

Once the Envelta IND-enabling studies are submitted to the FDA, the data may be cross-referenced to our cancer pain and PTSD INDs.

Virpax is developing branded product candidates for non-addictive pain management and neurological disorders using its proprietary technologies to optimize and target drug delivery.

Virpax is initially seeking FDA approval of its three patented drug delivery platforms. Epoladerm is a topical diclofenac spray film formulation being developed to manage osteoarthritis pain.

Probudur is a single injection long-acting liposomal bupivacaine formulation being developed to manage post-operative pain.

Envelta is an intranasal Molecular-Envelope Technology enkephalin formulation being developed for the management of acute and chronic pain, including pain associated with cancer, as well as post-traumatic stress disorder under the name PES200.

MET technology is also used in AnQlar, a candidate to inhibit viral replication caused by influenza or SARS-CoV-2.

Virpax recently acquired global rights to VRP324, a product candidate for the nasal delivery of a pharmaceutical-grade cannabidiol for the management of epilepsy in children (a rare pediatric disease) and adults.


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