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Virpax Announces Agreement with the U.S. Department of Health and Human Services for the Developmental Extension for NES100 Towards IND for Acute and Chronic Non-Cancer Pain Alternative

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Virpax Pharmaceuticals (NASDAQ: VRPX) has secured an extension of its cooperative research agreement with the National Center for Advancing Translational Sciences (NCATS) for developing NES100, an intranasal peptide for acute and chronic non-cancer pain management. NES100 uses nanotechnology to deliver enkephalin, a natural peptide, to the brain via a nasal route. The technology aims to suppress pain by binding to delta opioid receptors without the adverse effects typically associated with opioids, such as tolerance, withdrawal, respiratory depression, euphoria, or addiction. Animal models have shown promising analgesic potential.

Virpax Pharmaceuticals (NASDAQ: VRPX) ha ottenuto un'estensione del suo accordo di ricerca cooperativa con il National Center for Advancing Translational Sciences (NCATS) per lo sviluppo di NES100, un peptide intranasale per la gestione del dolore non oncologico acuto e cronico. NES100 utilizza la nanotecnologia per consegnare l'enkephalina, un peptide naturale, al cervello attraverso una via nasale. La tecnologia mira a sopprimere il dolore legandosi ai recettori oppioidi delta senza gli effetti avversi normalmente associati agli oppioidi, come tolleranza, astinenza, depressione respiratoria, euforia o dipendenza. I modelli animali hanno mostrato un promettente potenziale analgesico.

Virpax Pharmaceuticals (NASDAQ: VRPX) ha asegurado una extensión de su acuerdo de investigación cooperativa con el National Center for Advancing Translational Sciences (NCATS) para el desarrollo de NES100, un péptido intranasal para el manejo del dolor no canceroso agudo y crónico. NES100 utiliza nanotecnología para entregar enkephalina, un péptido natural, al cerebro a través de la vía nasal. La tecnología tiene como objetivo suprimir el dolor al unirse a los receptores opioides delta sin los efectos adversos normalmente asociados con los opioides, como la tolerancia, la abstinencia, la depresión respiratoria, la euforia o la adicción. Los modelos animales han mostrado un prometedor potencial analgésico.

Virpax Pharmaceuticals (NASDAQ: VRPX)는 NES100의 개발을 위해 National Center for Advancing Translational Sciences (NCATS)와의 협력 연구 계약을 연장했습니다. NES100은 급성 및 만성 비암성 통증 관리를 위한 비강펩타이드입니다. NES100은 나노기술을 사용하여 자연 펩타이드인 엔케팔린을 비강을 통해 뇌로 전달합니다. 이 기술은 델타 오피오이드 수용체에 결합하여 통증을 억제하는 것을 목표로 하며, 일반적으로 오피오이드와 연관된 내성, 금단 증상, 호흡 억제, 행복감 또는 중독과 같은 부작용을 피합니다. 동물 모델에서 유망한 진통 효과가 나타났습니다.

Virpax Pharmaceuticals (NASDAQ: VRPX) a obtenu une extension de son accord de recherche coopératif avec le National Center for Advancing Translational Sciences (NCATS) pour le développement de NES100, un peptide intranasal destiné à la gestion de la douleur non cancéreuse aiguë et chronique. NES100 utilise la nanotechnologie pour délivrer l'enképhaline, un peptide naturel, au cerveau par voie nasale. La technologie vise à supprimer la douleur en se liant aux récepteurs opioïdes delta sans les effets indésirables généralement associés aux opioïdes, tels que la tolérance, le sevrage, la dépression respiratoire, l'euphorie ou la dépendance. Des modèles animaux ont montré un potentiel analgésique prometteur.

Virpax Pharmaceuticals (NASDAQ: VRPX) hat eine Verlängerung seines Kooperationsforschungsabkommens mit dem National Center for Advancing Translational Sciences (NCATS) zur Entwicklung von NES100 gesichert, einem intranasalen Peptid zur Behandlung von akuten und chronischen nicht-krebsbedingten Schmerzen. NES100 verwendet Nanotechnologie, um Enkephalin, ein natürliches Peptid, über die nasale Route ins Gehirn zu transportieren. Die Technologie zielt darauf ab, Schmerzen zu unterdrücken, indem sie an Delta-Opioid-Rezeptoren bindet, ohne die typischen Nebenwirkungen von Opioiden wie Toleranz, Entzug, Atemdepression, Euphorie oder Sucht. Tiermodelle haben vielversprechendes analgesisches Potenzial gezeigt.

Positive
  • Extended research agreement with National Institutes of Health (NIH) for NES100 development
  • NES100 demonstrated pain relief in animal models without typical opioid side effects
  • Novel nanotechnology delivery system for enhanced drug administration
Negative
  • Product still in early development phase, not yet approved
  • No human clinical trial data available yet

Insights

This development agreement extension with NCATS represents a significant milestone in advancing NES100, a novel intranasal pain management solution. The technology's unique approach using enkephalin with Molecular Envelope Technology (MET) could potentially revolutionize non-opioid pain management. Key differentiators include:

  • Nasal delivery system that may enhance brain penetration
  • Demonstrated analgesic effects without typical opioid side effects
  • Novel mechanism targeting delta opioid receptors

While promising, investors should note that this is still in early development stages. The NCATS collaboration provides valuable resources and expertise but doesn't guarantee successful commercialization. The small market cap of $3.2M reflects the speculative nature of this development-stage company.

The extended collaboration with a prestigious government institution strengthens Virpax's position in developing alternative pain management solutions. The global non-opioid pain management market presents a substantial opportunity, driven by increasing concerns over opioid addiction. Market advantages for NES100 include:

  • Addressing an urgent medical need for non-addictive pain treatments
  • Potential first-mover advantage in intranasal enkephalin delivery
  • Government backing through the HEAL initiative

However, the company's micro-cap status and early development phase suggest high investment risk. Success depends on clinical trial outcomes and regulatory approval.

BERWYN, Pa.--(BUSINESS WIRE)-- Virpax Pharmaceuticals, Inc. (Nasdaq: VRPX) (“Virpax” or the “Company”), a company specializing in developing pharmaceutical products for pain management, announced that it has been granted an extension of its cooperative research and development agreement with the National Center for Advancing Translational Sciences (NCATS), an institute/center of the National Institutes of Health (NIH), U.S. Department of Health and Human Services. This collaboration is for the continued development of Virpax’s product candidate, NES100, an intranasal peptide, for the management of acute and chronic non-cancer pain.

NES100 is an enkephalin drug product based on a type of nanotechnology delivery approach. Enkephalin is a naturally occurring (endogenous) peptide that is not easily administered in its original form. We believe that the nanotechnology may enable and enhance the delivery of this metabolically labile peptide drug into the brain. NES100 is the first investigational product formulation delivered via the nasal route with the potential to enhance enkephalin transport to the brain. NES100 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 (MET) is designed to protect and help carry the drug to the brain with the goal of promptly suppressing pain by binding to the delta opioid receptors. NES100 has demonstrated analgesic potential in animal models without the development of opioid tolerance, withdrawal, respiratory depression, euphoria, or addiction associated with use of opioids.

Jatinder Dhaliwal, Chief Executive Officer of Virpax, commented, "We are excited that this collaboration has been extended with NCATS and the NIH Helping to End Addiction Long-term (HEAL) initiative as we believe that it may help Virpax develop an effective and safe alternative to conventional opioids used by patients to manage acute and chronic pain. We believe that the NIH/NCATS collaborative agreement will enable our team to maintain momentum in both our pre-clinical and clinical development strategies."

About Virpax Pharmaceuticals

Virpax is developing branded, non-addictive pain management products candidates using its proprietary technologies to optimize and target drug delivery. Virpax is initially seeking FDA approval for two prescription drug candidates that employ two different patented drug delivery platforms. Probudur™ is a single injection liposomal bupivacaine formulation being developed to manage post-operative pain and Envelta™ is an intranasal molecular envelope enkephalin formulation being developed to manage acute and chronic pain, including pain associated with cancer. Virpax is also using its intranasal Molecular Envelope Technology (MET) to develop one other prescription product candidate, NobrXiol™, which is being developed for the nasal delivery of a pharmaceutical-grade cannabidiol (CBD) for the management of rare pediatric epilepsy. Virpax has competitive cooperative research and development agreements (CRADAs) for two of its prescription drug candidates, one with the National Institutes of Health (NIH) and one with the Department of Defense (DOD). Virpax is also seeking partners for two nonprescription product candidates: AnQlar, which is being developed to inhibit viral replication caused by influenza or SARS-CoV-2, and Epoladerm™, which is a topical diclofenac spray film formulation being developed to manage pain associated with osteoarthritis. For more information, please visit https://www.virpaxpharma.com.and follow us on Twitter, LinkedIn and YouTube.

Forward-Looking Statements

This press release contains certain forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, as amended, including those described below. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions.

These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events and involve known and unknown risks, uncertainties, and other factors, including the additional capital which will be necessary to complete studies and clinical trials that the Company plans to initiate and other factors listed under “Risk Factors” in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q that the Company has filed with the U.S. Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Investor Contact:

info@virpaxpharma.com

Source: Virpax Pharmaceuticals, Inc.

FAQ

What is Virpax's NES100 designed to treat?

NES100 is designed to treat acute and chronic non-cancer pain as an alternative to conventional opioids.

How does Virpax (VRPX) NES100 work?

NES100 uses Molecular Envelope Technology to deliver enkephalin through the nose to the brain via the olfactory nerve pathway, binding to delta opioid receptors to suppress pain.

What are the advantages of Virpax's (VRPX) NES100 over traditional opioids?

According to animal studies, NES100 provides pain relief without developing opioid tolerance, withdrawal, respiratory depression, euphoria, or addiction typically associated with conventional opioids.

Who is partnering with Virpax (VRPX) for NES100 development?

Virpax is partnering with the National Center for Advancing Translational Sciences (NCATS), part of the National Institutes of Health (NIH), for NES100 development.

Virpax Pharmaceuticals, Inc.

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