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Virpax Announces Results of Maximum Tolerated Dose Study for Probudur™

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Virpax Pharmaceuticals, Inc. announced the results of a Maximum Tolerated Dose (MTD) study for Probudur™, a long-acting liposomal bupivacaine formulation aimed at reducing the need for opioids after surgery. The study showed that Probudur provided both immediate and sustained pain relief at the wound site, with minimal toxicity and better therapeutic results compared to free bupivacaine. The formulation demonstrated the potential to offer rapid onset and prolonged action, marking significant progress towards completing preclinical studies and filing for an Investigational New Drug Application (IND) by the end of the year.

Virpax Pharmaceuticals, Inc. ha annunciato i risultati di uno studio sulla Dose Massima Tollerata (MTD) per Probudur™, una formulazione liposomiale di bupivacaina a lunga durata, progettata per ridurre la necessità di oppioidi dopo un intervento chirurgico. Lo studio ha dimostrato che Probudur fornisce un sollievo dal dolore immediato e prolungato nella zona della ferita, con una tossicità minima e risultati terapeutici migliori rispetto alla bupivacaina libera. La formulazione ha dimostrato il potenziale per offrire un'azione rapida e prolungata, segnando un progresso significativo verso il completamento degli studi preclinici e la presentazione della domanda di autorizzazione per un Nuovo Farmaco Sperimentale (IND) entro la fine dell'anno.
Virpax Pharmaceuticals, Inc. anunció los resultados de un estudio de Dosis Máxima Tolerada (MTD) para Probudur™, una formulación liposomal de bupivacaína de acción prolongada destinada a reducir la necesidad de opioides tras una cirugía. El estudio reveló que Probudur proporciona alivio del dolor inmediato y sostenido en el sitio de la herida, con mínima toxicidad y mejores resultados terapéuticos en comparación con la bupivacaína libre. La formulación demostró potencial para ofrecer un inicio rápido y acción prolongada, marcando un avance significativo hacia la finalización de estudios preclínicos y la solicitud de una Aplicación de Nuevo Fármaco en Investigación (IND) para fin de año.
Virpax Pharmaceuticals, Inc.는 수술 후 오피오이드의 필요성을 줄이기 위해 설계된 장기 지속형 리포좀 bupivacaine 제제인 Probudur™의 최대 내약량(MTD) 연구 결과를 발표했습니다. 연구 결과 Probudur는 상처 부위에서 즉각적이고 지속적인 통증 완화를 제공하며, 최소한의 독성과 자유 bupivacaine에 비해 더 나은 치료 결과를 나타냈습니다. 이 제제는 빠른 시작과 장기 작용을 제공할 잠재력을 보여주었으며, 연말까지 전임상 연구를 완료하고 새로운 약물 조사(New Drug Application, IND)를 신청하는 데 중요한 진전을 이루었습니다.
Virpax Pharmaceuticals, Inc. a annoncé les résultats d'une étude sur la Dose Maximale Tolérée (DMT) pour Probudur™, une formulation liposomale de bupivacaïne à action prolongée visant à réduire le besoin d'opioïdes après une chirurgie. L'étude a montré que Probudur offre un soulagement de la douleur immédiat et soutenu au niveau du site de la plaie, avec une toxicité minimale et de meilleurs résultats thérapeutiques par rapport à la bupivacaïne libre. La formulation a démontré le potentiel d'offrir un début rapide et une action prolongée, marquant des progrès significatifs vers l'achèvement des études précliniques et le dépôt d'une demande de Nouveau Médicament Investigational (IND) d'ici la fin de l'année.
Virpax Pharmaceuticals, Inc. gab die Ergebnisse einer Studie zur Höchsttolerierten Dosis (MTD) für Probudur™ bekannt, eine langwirkende liposomale Bupivacain-Formulierung, die darauf abzielt, den Bedarf an Opioiden nach Operationen zu reduzieren. Die Studie zeigte, dass Probudur sofortige und anhaltende Schmerzlinderung an der Wundstelle bietet, mit minimaler Toxizität und besseren therapeutischen Ergebnissen im Vergleich zu freiem Bupivacain. Die Formulierung zeigte das Potenzial für schnellen Wirkungseintritt und langanhaltende Wirkung, was einen bedeutenden Fortschritt in Richtung Abschluss präklinischer Studien und Einreichung eines Antrags auf eine Investigational New Drug Application (IND) bis Ende des Jahres darstellt.
Positive
  • Probudur demonstrated both immediate and sustained pain relief in the MTD study, showcasing its potential to reduce the need for opioids post-surgery.

  • The formulation's liposomal design allowed for better therapeutic results compared to free bupivacaine, with minimal toxicity and well-tolerated doses in rats.

  • Results indicated that Probudur offers rapid onset and prolonged action, eliminating the need for simultaneous administration of free bupivacaine.

  • The successful study outcomes bring the company a step closer to completing required preclinical studies and submitting an IND for Probudur by the year's end.

Negative
  • Some treatment groups in the MTD study showed minimal to moderate histopathological changes at the injection site, with slightly more pronounced effects at higher doses of Probudur.

  • Although well-tolerated in the study, there may still be potential adverse effects observed in human clinical trials that were not evident in the animal study.

The announcement by Virpax Pharmaceuticals about the results of a Maximum Tolerated Dose (MTD) study for Probudur™ in rodents provides valuable insight into the safety profile of the drug. The study is a fundamental step in the preclinical phase, aiming to establish the range of doses that a subject can tolerate without severe side effects. For investors, it could signal the potential for Probudur to advance through the regulatory pathway and eventually to market. The implication here is that Probudur could potentially reduce reliance on opioids post-surgery, addressing a significant public health concern. However, investors should be aware that preclinical results do not always translate to human trials and the drug has numerous regulatory hurdles yet to clear.

From a financial standpoint, Virpax's progress with Probudur can be seen as a strategic move in the pain management market, a sector that has been under scrutiny due to the opioid crisis. A non-opioid alternative like Probudur could capture significant market share if approved and marketed effectively. Virpax's planned Investigational New Drug (IND) filing is a critical next step and could impact the company's financial projections based on the costs associated with advancing through clinical phases. The drug's potential to address a sizable market could entice investment, but until further efficacy and safety data in humans are available, the financial risk remains high. Investors should monitor the company's burn rate and capital-raising activities as these will be important indicators of its ability to sustain drug development efforts.

The characteristics of Probudur, particularly its liposomal delivery system, are noteworthy because they represent a technological advancement in drug formulation. This technology could offer a differentiation point from other anesthetics, potentially leading to a competitive advantage. As this is a technically complex product, understanding its mechanism—how it provides both immediate and extended pain relief—is important. The liposomal formulation encapsulates the active drug, allowing for a controlled release at the wound site, which addresses both efficacy and safety concerns. While this is promising, it is important to note that there is a long road from a successful MTD study in rats to a commercially viable product. Investors interested in the pharmaceutical sector should look for consistent and transparent updates from Virpax regarding the progression of their clinical trials and any partnership opportunities they may engage in to support the development and distribution of Probudur.

-Liposomal Formulation Developed to Provide Both Immediate and Sustained Pain Relief-

BERWYN, Pa.--(BUSINESS WIRE)-- Virpax® Pharmaceuticals, Inc. (“Virpax” or the “Company”) (NASDAQ: VRPX), a company specializing in developing non-addictive products for pain management, post-traumatic stress disorder, central nervous system (CNS) disorders and anti-viral barrier indications, today announced results for a Maximum Tolerated Dose (MTD) study in Sprague-Dawley Rats for Probudur™.

Probudur is Virpax’s injectable long-acting liposomal bupivacaine formulation that is injected at the wound site. Probudur is being developed to significantly reduce or eliminate the need for opioids after surgery in approved indications. Probudur is a local anesthetic that binds to the sodium channel, preventing pain signals from reaching the brain. In pre-clinical trials, Probudur has shown long duration pain control for at least 96 hours, with a rat incisional model demonstrating analgesia for up to five days and in vitro studies demonstrating a slow release of bupivacaine that lasted for up to six days.

The study was designed to determine the MTD of free bupivacaine, Probudur, and Probudur plus free bupivacaine when administered as a single subcutaneous injection to the wound. Probudur, with its liposomal formulation, is intended to provide both immediate and extended pain relief at the wound site. The dosing ranges were selected based on a prior preliminary study. All doses of Probudur were well-tolerated. There were no noteworthy effects on body weight, clinical chemistry, hematology, or coagulation. It was also observed that bupivacaine appears to be less toxic in the presence of liposomes than when administrated as a free drug.

Histopathology was conducted on the injection site and all treatment groups showed some changes which were minimal to moderate in severity. Effects were slightly more pronounced at the high dose of Probudur. In vivo MTD studies in rats indicated that Probudur provided a better therapeutic window as compared to free bupivacaine.

“These results confirm our belief that Probudur is well-tolerated in animals and a single injection of this proprietary liposomal formulation of bupivacaine has the potential to provide both immediate relief as well as sustained relief at the wound site,” stated Gerald Bruce, CEO of Virpax Pharmaceuticals. “Probudur’s proprietary formulation allows for both rapid onset and prolonged duration of action, obviating the need for simultaneous administration of free bupivacaine. We are now another step closer to completing our required preclinical studies and plan to file an Investigational New Drug Application (IND) for Probudur by the end of the year.”

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 approval of 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 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 and include statements regarding Probudur significantly reducing or eliminating the need for opioids after surgery in approved indications, Probudur providing immediate pain relief at the wound site, as well as extended support for pain reduction, Probudur being well-tolerated in animals and that a single injection of this proprietary liposomal formulation of bupivacaine having the potential to provide both immediate relief as well as sustained relief at the wound site, being another step closer to completing required preclinical studies and filing an Investigational New Drug Application (IND) for Probudur by the end of the year, subject to adequate financing. These statements relate to future events and involve known and unknown risks, uncertainties, and other factors, including the Probudur’s ability to significantly reduce or eliminate the need for opioids after surgery in approved indications, the Company’s ability to file an IND by the end of the year, to obtain FDA approval for its prescription drug candidates and nonprescription drug candidates; the Company’s ability to maintain competitive cooperative research and development agreements (CRADAs) for its prescription drug candidates; the Company’s ability to successfully complete research and further development and commercialization of Company drug candidates in current or future indications; the Company’s ability to obtain additional grants to help fund upcoming clinical trials; the Company’s ability to move ahead with remaining confirmational studies for Probudur as planned; the Company’s ability to manage and successfully complete clinical trials and the research and development efforts for multiple product candidates at varying stages of development; the timing, cost and uncertainty of obtaining regulatory approvals for the Company’s product candidates; the Company’s ability to protect its intellectual property; the Company’s ability to obtain capital to meet its current and long-term liquidity needs on acceptable terms, or at all, 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 Relations:

Betsy Brod

Affinity Growth Advisors

Betsy.brod@affinitygrowth.com

(917) 923-8541

Media:

Robert Cavosi

RooneyPartners

rcavosi@rooneypartners.com

(646) 638-9891

Source: Virpax Pharmaceuticals

FAQ

What were the results of the Maximum Tolerated Dose study for Probudur™?

Probudur demonstrated both immediate and sustained pain relief in the study, showing potential to reduce opioid use after surgery.

How long did Probudur provide pain control in pre-clinical trials?

Probudur showed long duration pain control for at least 96 hours, with additional studies demonstrating up to five days of analgesia and six days of bupivacaine release.

What is Probudur's mechanism of action?

Probudur is a local anesthetic that binds to the sodium channel, blocking pain signals from reaching the brain.

When does Virpax plan to file an Investigational New Drug Application for Probudur?

Virpax aims to submit an IND for Probudur by the end of the year, following the positive MTD study results.

Virpax Pharmaceuticals, Inc.

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