WE ARE OPTIMIZING NON-ADDICTIVE DRUG DELIVERY
Our proprietary and transforming drug-releasing technologies have been developed to advance the treatment of pain and neurodegenerative disorders worldwide using non-addictive drug compounds.
Molecular Envelope Technology (MET)
Using MET, we are working to enhance enkephalin transport to the brain through a nanoparticle formulation. This nanotechnology enables metabolically labile peptide molecules, like enkephalin, to pass through the blood-brain barrier in order to help manage severe post cancer pain and non-cancer pain. 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
BLOOD-BRAIN BARRIER BYPASS
The MET protects the enkephalin from degradation as it bypasses the blood brain barrier into the olfactory region targeting the Delta receptors to control severe pain
Topical Spray Film
Virpax has licensed a patented topical spray system that delivers the nonsteroidal anti-inflammatory drug Diclofenac Epolamine to the skin. This proprietary spray formulation delivers Diclofenac to the skin as a film without messy handling or need to wash hands after application while maintaining comparable skin absorption capabilities to topical creams and gels 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 spray on valve
Liposomal in Hydrogel Encapsulation
Our patented liposomal formulation 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 analgesic effect for 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 analgesic effect for 96 hours at the wound site
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 postoperative outcomes
We are advancing novel products by combining widely used and newly developed non-addictive drug compounds with cutting-edge delivery technologies. Each product candidate offers its own advantages to the franchise, giving healthcare providers the options and treatment alternatives they seek.
TARGET MARKET
Severe post cancer pain and non-cancer analgesic market
DELIVERY SYSTEM
Intranasal Molecular Envelope Technology (MET)
POTENTIAL 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
- Our IND-enabling studies have determined that the MET intranasal delivery formulation bypasses the liver, avoiding potential drug to drug interactions if taking concomitant medicine
“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.”
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 the morphine 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.
Probudur™
Injectable long-acting bupivacaine hydrogel
Pre-IND Guidance Completed
Probudur™
Injectable long-acting bupivacaine hydrogel
Pre-IND Guidance Completed
TARGET MARKET
Local anesthetic post-surgical pain market
DELIVERY SYSTEM
Liposomal in hydrogel encapsulation
POTENTIAL BENEFITS
- Single dose infiltration into the surgical or wound site
- Prolonged postoperative analgesia effect for 96 hours
- May eliminate the need for opioids after surgery
- May reduce associated costs and length of hospital stay
- Produced no evidence of motor or sensory nerve damage at a dose that was 10 times higher than free bupivacaine in animal studies
- Animal studies demonstrated 96 hours of local anesthetic activity at wound site
MECHANISM OF ACTION
Bupivacaine works when injected into the wound by binding to the ‘sodium channel’ and blocking the influx of sodium ions; this inhibits nerve conduction and prevents pain signals from reaching the brain after surgery. In our pre-clinical studies, the Liposomal Hydrogel Bupivacaine acts as an ultra-long acting formulation with a 96-hour duration at the wound site.
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.
USAISR CRADA
Preclinical pain models for Probudur are being assessed under a Cooperative Research and Development Agreement (“CRADA”) entered into by Virpax and the U.S. Army Institute of Surgical Research (USAISR). The USAISR is the Department of Defense’s primary laboratory for developing solutions to trauma and critical care challenges in combat casualties.
Epoladerm™
Diclofenac topical spray film
First in Human Trial Pending
TARGET MARKET
Osteoarthritis of the knee
DELIVERY SYSTEM
Topical spray film
Image is for illustration purposes only
POTENTIAL BENEFITS
- Improved drying, less messy, and better bioavailability
- Reliable and reproducible blood levels
- Improved patient compliance that could result in enhanced therapeutic outcomes
- Sustained pain control over 24 hours with one application
“Osteoarthritis is a painful condition that results in reduced physical function and quality of life and increased risk of all-cause mortality. A large, recent meta-analysis on pharmacologic treatments for knee and hip osteoarthritis indicated that topical diclofenac had the largest effect on pain and physical function with a better safety profile than oral diclofenac and might be the best treatment in terms of effectiveness and safety. These agents should be considered as a first-line pharmacological treatment for knee osteoarthritis.“
BRITISH MEDICAL JOURNAL
2021;375:N2321
MECHANISM OF ACTION
Topical Diclofenac Epolamine has an anti-inflammatory/antipyretic/analgesic action due to the inhibition of prostaglandin synthesis by inhibition of cyclooxygenase.
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.
AnQlar™
High-density molecular intranasal spray
IND Enabling Studies Initiated
AnQlar™
High-density molecular intranasal spray
IND Enabling Studies Initiated
TARGET MARKET
Prophylactic prevention of the spread of negatively charged viruses like Covid-19 and influenza
DELIVERY SYSTEM
Intranasal MET-nanoparticle dispersion delivery
POTENTIAL 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 may be used as a frontline defense against disease spread in close settings
- AnQlar may be used by vaccinated and unvaccinated individuals to prevent viral spread
- 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
- Targeted delivery in the nasal mucosa where viral infection starts
MECHANISM OF ACTION
AnQlar and Quaternary ammonium chitosan (QAC) are highly related; Chitosan is a natural anti-microbial. Both are very positively charged mucoadhesive molecules that bind electrostatically to negatively charged coronaviruses. However, QACs are more toxic to the cells, making pH levels unacceptable for human use.
AnQlar’s modified chemical structure makes the molecule more hydrophilic than QAC. AnQlar’s hydrophilic property allow it to self assemble into nanoparticles in water to improve antiviral activity at pH levels acceptable for use in humans. AnQlar may have two mechanisms of action: it is virucidal and it prevents viral entry into cells via the angiotensin-converting enzyme-2 (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.
VRP324
Intranasal pharmaceutical-grade Schedule V cannabidiol (CBD)
Drafting Pre-IND Documents
VRP324
Intranasal pharmaceutical-grade Schedule V cannabidiol (CBD)
Drafting Pre-IND Documents
TARGET MARKET
Management of Rare Pediatric Epilepsy; Rare Pediatric Disease (RPD)
DELIVERY SYSTEM
Intranasal Molecular Envelope Technology (MET)
POTENTIAL BENEFITS
- VRP324 will be using significantly less pharmaceutical-grade CBD than current FDA approved oral CBD dosing
- VRP324 may achieve higher efficiency via the nasal route and reduce peripheral side effects like dose dumping due to high-fat meals
- Since peripheral exposure via the plasma will be reduced by the nose to brain delivery, we believe there will be negligible liver first-pass metabolism
- VRP324 may not be metabolized in the liver avoiding drug to drug interactions caused by oral pharmaceutical-grade CBD
- By avoiding the first pass effect Intranasal VRP324 may eliminate enzymatic degradation or deactivation. Enzymatic deactivation occurs when an enzyme changes the structure of a neurotransmitter so that the receptor no longer recognizes the neurotransmitter
MECHANISM OF ACTION
Highly purified pharmaceutical-grade cannabidiol (CBD), approved in the United States, has demonstrated efficacy with an acceptable safety profile in patients with Lennox-Gastaut or Dravet syndrome. CBD acts on cannabinoid (CB) receptors of the endocannabinoid system, which are found in numerous body areas, including the peripheral system and the central nervous systems, including the brain. The endocannabinoid system regulates many physiological responses of the body and neuronal excitability responses relevant to the pathophysiology of many disease types, including epilepsy.
NEW DRUG APPLICATION (NDA)
Virpax will pursue an accelerated 505(b)(2) New Drug Application for VRP324.
First Pass Effect: The first pass effect is a phenomenon of drug metabolism whereby the concentration of a drug, specifically when administered orally, is greatly reduced before it reaches the systemic circulation. It is the fraction of drug lost during the process of absorption which is generally related to the liver and gut wall.
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.
About a New Chemical Entity (NCE)
A New Chemical Entity (NCE) is a drug that does not contain an active ingredient that has been approved by the U.S. Food and Drug Administration (FDA) with any other application submitted under 505(b)(1) regulatory pathways. NCEs are generally developed during the early discovery stage of the product cycle, then undergo various clinical trials that can transform the active ingredient into a product. All investigations supporting safety and effectiveness, both clinical and non-clinical, under 505(b)(1), are conducted by or on behalf of the Sponsor. The FDA can provide exclusivity to an NCE so no other manufacturer can apply for a product with the same active ingredient for a determined amount of time.
Rare Pediatric Disease (RPD) Designation and Voucher Programs
Under Section 529 to the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA will award priority review vouchers to sponsors of rare pediatric disease product applications that meet certain criteria. Under this program, a sponsor who receives an approval for a drug or biologic for a “rare pediatric disease” may qualify for a voucher that can be redeemed to receive a priority review of a subsequent marketing application for a different product.
