Products
WE ARE OPTIMIZING NON-ADDICTIVE DRUG DELIVERY
Our proprietary and transforming drug-releasing technologies have been developed using non-addictive drug compounds to advance the treatment of pain and neurodegenerative disorders worldwide.
Proprietary DRUG-DELIVERY SYSTEMS
We’re developing molecules with the MET to deliver treatment options for the management of:
Liposomal in Hydrogel encapsulation
Virpax uses a patented injectable liposomal hydrogel encapsulation to deliver a local anesthetic at the wound/incision site providing pain control for 96 hours.
We’re using liposomal hydrogel encapsulation to develop a local anesthetic for:
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 CRADA AWARDED 8/31/20
Virpax advances Envelta development with NCATS under CRADA Agreement to support the development and manufacturing of Envelta. The National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) has awarded research and development contracts to support 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 to develop Envelta.
*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.
VRP324
Intranasal pharmaceutical-grade Schedule V cannabidiol (CBD)
Pre-IND Documents Submitted
VRP324
Intranasal pharmaceutical-grade Schedule V cannabidiol (CBD)
Pre-IND Written Response Pending
TARGET MARKET
Management of Rare Pediatric Epilepsy; Rare Pediatric Disease (RPD)
DELIVERY SYSTEM
Intranasal Molecular Envelope Technology (MET)
POTENTIAL BENEFITS
- VRP324 may 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.
“The effects of rare neurodegenerative diseases are devastating, with very few effective therapeutic options available to patients. We recognize the urgent need for new treatments that can both improve and extend the lives of people diagnosed with these diseases.”
“… the FDA is working toward meeting the task set forth by Congress to enhance the quality of life for those suffering by facilitating access to new therapies.”
ROBERT M. CALIFF, M.D.
FDA Commissioner
Probudur™
Injectable long-acting bupivacaine hydrogel
Pre-IND Guidance Completed
Probudur™
Injectable long-acting bupivacaine hydrogel
Animal Efficacy Studies Pending
TARGET MARKET
Local anesthetic post-surgical pain market
DELIVERY SYSTEM
Liposomal in hydrogel encapsulation
POTENTIAL BENEFITS
- 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
“FDA takes steps aimed at fostering development of non-addictive alternatives to opioids for acute pain management lasting up to 30 days, in response to some form of tissue injury, such as trauma or surgery.”
U.S. Food and Drug Administration
FEBRUARY 2022
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 AWARDED 5/05/22
Virpax entered into a cooperative research and development agreement (CRADA) with the U.S. Army Institute of Surgical Research (USAISR) on May 5, 2022 to evaluate Virpax’s Probudur, an injectable long-acting liposomal bupivacaine in a hydrogel formulation that is injected at the wound site. In pre-clinical trials, Probudur has shown pain control for 96 hours. The USAISR is the U.S. Department of Defense’s (DOD) primary laboratory for developing solutions for trauma and critical care challenges in combat casualties.
Epoladerm™
Diclofenac topical spray film
First in Human Trial Pending
TARGET MARKET
Osteoarthritis pain
DELIVERY SYSTEM
Topical spray film
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.
CONSUMER OTC
AnQlar™
High-density molecular intranasal spray
Consumer Health Studies Initiated
AnQlar™
High-density molecular intranasal spray
Consumer Health Studies Initiated
TARGET MARKET
Prophylactic barrier to 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 be a viral barrier against 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 and viral barrier activity in the nasal mucosa where viruses start
MECHANISM OF ACTION
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 viral barrier activity at the surface cell at pH levels acceptable for use in humans. AnQlar prevents viral entry into cells via the angiotensin-converting enzyme-2 (ACE-2) receptor.
OTC MEDICAL DEVICE
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.
Drug Application Process for Direct to Nonprescription or direct-to-OTC Drugs
Under the drug application process, a sponsor of a nonprescription drug submits a New Drug Application (NDA) or an Abbreviated New Drug Application (ANDA) to FDA for approval. The sponsor cannot market the nonprescription drug until FDA approves the NDA or ANDA. One important difference between a drug application for a prescription drug and a nonprescription drug is that consumer behavior studies are often needed to demonstrate that consumers can use the nonprescription drug product safely and effectively without the supervision of a healthcare provider. The consumer behavior studies conducted by a sponsor of nonprescription drug typically include: label comprehension, self-selection, actual use, and human factors studies. FDA encourages all potential drug sponsors to initiate contact with the Office of Nonprescription Drugs (NDA products) or the Office of Generic Drugs (ANDA products) as early as possible, so that drug sponsors can consider FDA’s product development recommendations.
