WE ARE TARGETING PAIN AT ITS SOURCE
Our novel drug compounds, improved drug-delivery systems, and drug-releasing technologies are focused on advancing pain management treatments allowing healthcare professionals to target a patient’s pain at its source. Our products cover a range of applications from postoperative pain to the treatment of acute and chronic pain, including pain associated with cancer.
Enkephalin Intranasal spray
Using Molecular Envelope Technology (MET), we are working to enhance enkephalin transport to the brain through an intranasal formulation. This nanotechnology enables metabolically labile peptide molecules, like enkephalin, to pass through the blood-brain barrier in order to help manage acute and chronic pain, including pain associated with cancer. These enkephalin-filled nanoparticles are preloaded into a cartridge with compressed inert gas as a single dose that is compatible with our specialized device. With a simple press of a button, the device releases this powder as a long and thin plume penetrating the olfactory region.
DRUG LOADED NANOPARTICLES
The enkephalin molecule is loaded in nanoparticles
EASY-TO-USE DEVICE
No breath coordination required. Caregiver can administer to an incapacitated person
BLOOD-BRAIN BARRIER BYPASS
Drug bypasses the blood brain barrier by targeting the olfactory region
Transdermal metered-dose spray
Virpax has licensed a patented metered-dose spray system that delivers active pharmaceutical ingredients (API). This proprietary spray formulation delivers the API as a film and may lead to adhesion capabilities superior to those of transdermal patches, while maintaining comparable skin absorption capabilities to transdermal patches currently on the market.
CONVENIENT
No messy cream or gels that can be rubbed off by clothing or physical contact
AESTHETICALLY APPEALING
Invisible once applied
EASILY OPTIMIZABLE
Use with metered-dose delivery valves
Liposomal in Hydrogel encapsulation
Our patented liposomal gel encapsulates a high dose of local anesthetic in hydrogel, cholesterol, and other “GRAS” lipids. A single dose can be injected at the surgical site to provide a prolonged postoperative analgesia effect for up to 96 hours. This may enhance recovery protocols, reduce the length of a patient’s hospital stay post-surgery, and significantly reduce or eliminate the use of opioids.
PROLONGED EFFECTS
Postoperative analgesia effect for up to 96 hours
EFFICIENT DRUG-DELIVERY
Improved onset of action and peak analgesic activity in post-operative setting
IMPROVED QUALITY OF CARE
Reduce reliance on opioid pain management; may lead to experience better rehabilitation outcomes
TARGET MARKET
Moderate to severe analgesic market
DELIVERY SYSTEM
Endogenous enkephalin intranasal spray
BENEFITS
- Enkephalin pro-drug formulation that targets delta receptors instead of mu receptors that are responsible for the majority of undesirable side effects associated with morphine
- Analgesic potential to manage acute and chronic pain, including pain associated with cancer, without the concerns of opioid tolerance, withdrawal, respiratory depression, or euphoria
- Delta opioid receptors have a built-in mechanism for pain relief. They can be precisely targeted with drug-delivering nanoparticles, making them a promising target for treating chronic inflammatory pain with fewer side effects. Journal of Controlled Release. (Vol 270, 28; Jan 2018, P135-144)
MECHANISM OF ACTION
Brain delivery: Molecular Envelope Technology (MET) allows for highly stable nanoparticles to wrap around and encapsulate hydrophobic drugs and peptides, creating a protective molecular “envelope.” MET allows for increased bioavailability of drugs that would otherwise be rapidly degraded. In the case of intranasally administered Envelta™, MET increases dwell time in the nares promoting delivery via the olfactory route across the blood brain barrier and into the central nervous system. Here they target the delta opioid receptors, promoting analgesia (pain relief) without characteristic mu opioid related side-effects.
NEW DRUG APPLICATION (NDA)
As a result of our PreIND review, the FDA has indicated that it is reasonable for Virpax to pursue a New Chemical Entity (NCE) New Drug Application for Envelta.
NCATS IN-KIND AWARD
The IND enabling studies for Envelta are being performed under a Cooperative Research and Development Agreement (“CRADA”) In-kind Award entered into by Virpax and the National Center for Advancing Translational Sciences (“NCATS”). NCATS is one of 27 Centers at the National Institutes of Health (NIH) that was established to transform the translational process so that new treatments and cures for disease can be delivered to patients faster.
*We are also developing Envelta™ for a second indication, PES200, which utilizes the same delivery mechanism as Envelta™. PES200 enables the delivery of a metabolically liable peptide drug (Enkephalin) into the brain for post-traumatic stress disorder. The Envelta™ IND enabling studies may be cross-referenced to the PES200 IND.
TARGET MARKET
Topical musculoskeletal pain market
DELIVERY SYSTEM
Metered-dose spray film
Image is for illustration purposes only
BENEFITS
- Improved drying, less messy, and better skin absorption
- Better adhesiveness with direct skin contact
- Reliable and reproducible blood levels
- Better accessibility to active joints: wrists, ankles, knees, and elbows
- Improved patient compliance that could result in enhanced therapeutic outcomes
NEW DRUG APPLICATION (NDA)
As a result of our PreIND review, the FDA has indicated that it is reasonable for Virpax to pursue an accelerated 505(b)(2) New Drug Application for Epoladerm.
†We are also developing Epoladerm as a twice daily topical treatment for chronic osteoarthritis of the knee.
Probudur™
Injectable long-acting bupivacaine liposomal-gel
CAPITAL FUNDING
Probudur™
Injectable long-acting bupivacaine hydrogel
CAPITAL FUNDING
TARGET MARKET
Local anesthetic post-surgical pain market
DELIVERY SYSTEM
Liposomal in hydrogel encapsulation
BENEFITS
- Single dose infiltration into the surgical surgical or wound site
- Prolonged postoperative analgesia effect up to 96 hours
- May eliminate the need for opioids and catheters after surgery
- May reduce associated costs and length of patient stay
- Produced no evidence of motor or sensory nerve damage at a dose that was 10 times higher than free bupivacaine in animal studies
NEW DRUG APPLICATION (NDA)
As a result of our PreIND review, the FDA has indicated that it is reasonable for Virpax to pursue an accelerated 505(b)(2) New Drug Application for Probudur.
AnQlar™ (MMS019)
High-density molecular masking spray
GRANT/CAPITAL
AnQlar™ (MMS019)
High-density molecular masking spray
GRANT/CAPITAL
TARGET MARKET
Prevention of the spread of Covid-19 and seasonal flu epidemics
DELIVERY SYSTEM
Intranasal MET-nanoparticle dispersion delivery
BENEFITS
- An adjuvant to barrier-based personal protective equipment (PPE) to help mitigate the risks of poorly fitting equipment and over-used PPE with partially compromised barrier layers
- AnQlar could be used as a frontline defense against disease spread in close settings
- Clinical and commercial manufacturing supply agreement in place
- AnQlar shown to inhibit the ability of the virus to replicate at non-toxic concentrations
- May prevent the spread of influenza and SARS-CoV-2 for 24 hours
- May prevent brain viral load due to flu and SARS-CoV-2
- Demonstrated >18 months stability
MECHANISM OF ACTION
AnQlar is closely related to the quaternary ammonium carbohydrate N-(2-hydroxypropyl)-3-trimethylammonium chitosan chloride (HTCC) which can prevent the binding of coronavirus to the ACE-2 receptor on the surface of nasal epithelial cells. AnQlar may have two mechanisms of action: virucidal properties and prevention of entry into cells via the ACE-2 receptor.
NEW DRUG APPLICATION (NDA)
If we successfully complete the required clinical trials for this product candidate, we intend to move forward and pursue an NDA for AnQlar as a once daily intranasal treatment.
The FDA has indicated that, upon successful completion of studies, we may pursue an NDA drug approval with the Office of Non-Prescription Drugs.
About the 505(b)(2) regulatory pathway
The 505(b)(2) regulatory pathway is a type of New Drug Application (NDA) submission that encourages further innovation of drugs that have already received approval from the U.S. Food and Drug Administration (FDA). This pathway allows for faster approval times as it can avoid unnecessary duplication of studies that were already performed on approved drugs.
A 505(b)(2) NDA contains full safety and effectiveness reports, however the FDA can rely on other data not developed by the NDA applicant when considering drug approval. This data, like safety and efficacy information, can come from other studies of previously approved pharmacological agents that are similar in nature.
Virpax utilizes this unique regulatory pathway by applying our proprietary and patented delivery-systems and innovative technology to previously-approved drugs. We are then able to accelerate the development and approval process of our products.
About a New Chemical Entity (NCE)
A New Chemical Entity (NCE) is a drug that does not contain any active moiety that has been approved by the U.S. Food and Drug Administration (FDA) with any other application submitted under 505(b) regulatory pathways. NCEs are generally developed during the early discovery stage of the product cycle, then undergo various clinical trials that can transform the drug into a product. The FDA can provide exclusivity to an NCE so no other manufacturer can apply for a product with the same active moiety for a determined amount of time.
