Virpax Announces Positive Results for the Swine Model Dose Range Finding Study for Probudur™
Virpax Pharmaceuticals (NASDAQ: VRPX) announced positive results from a minipig Dose Range Finding study for Probudur, their long-acting liposomal bupivacaine formulation for pain management. The study evaluated Probudur's tolerance in an incisional wound healing model, with all minipigs showing positive tolerance and no adverse effects. Preclinical studies demonstrated pain control lasting up to 96 hours, with rat models showing analgesia for up to five days and in vitro studies showing bupivacaine release for up to six days. Probudur aims to provide immediate and extended pain relief while reducing or eliminating post-surgical opioid needs.
Virpax Pharmaceuticals (NASDAQ: VRPX) ha annunciato risultati positivi da uno studio di ricerca del dosaggio su minipig per Probudur, la loro formulazione liposomiale di bupivacaina a lunga durata d'azione per la gestione del dolore. Lo studio ha valutato la tolleranza di Probudur in un modello di guarigione di ferite incisionale, con tutti i minipig che hanno mostrato una tolleranza positiva e nessun effetto avverso. Gli studi preclinici hanno dimostrato un controllo del dolore che dura fino a 96 ore, con modelli di ratto che mostrano analgesia fino a cinque giorni e studi in vitro che mostrano il rilascio di bupivacaina fino a sei giorni. Probudur mira a fornire un sollievo immediato ed esteso dal dolore riducendo o eliminando la necessità di oppioidi post-chirurgici.
Virpax Pharmaceuticals (NASDAQ: VRPX) anunció resultados positivos de un estudio de búsqueda de dosis en minipig para Probudur, su formulación liposomal de bupivacaína de larga duración para el manejo del dolor. El estudio evaluó la tolerancia de Probudur en un modelo de curación de heridas quirúrgicas, mostrando todos los minipig una tolerancia positiva y sin efectos adversos. Los estudios preclínicos demostraron un control del dolor que dura hasta 96 horas, con modelos de ratas que mostraron analgesia de hasta cinco días y estudios in vitro que mostraron la liberación de bupivacaína hasta por seis días. Probudur tiene como objetivo proporcionar un alivio inmediato y prolongado del dolor mientras reduce o elimina la necesidad de opioides postquirúrgicos.
Virpax Pharmaceuticals (NASDAQ: VRPX)는 통증 관리를 위한 장시간 작용하는 리포좀성 부피바카인 제제인 Probudur의 마 pig 용량 범위 탐색 연구에서 긍정적인 결과를 발표했습니다. 이 연구는 절개 상처 치유 모델에서 Probudur의 내성을 평가했으며, 모든 미니피그가 긍정적인 내성을 보였고 부작용이 없었습니다. 전임상 연구는 최대 96시간 동안 통증 조절을 보여주었으며, 쥐 모델은 최대 5일간의 진통 효과를 보였고, 시험관 내 연구는 최대 6일 동안 부피바카인의 방출을 보여주었습니다. Probudur는 즉각적이고 지속적인 통증 완화를 제공하여 수술 후 오피오이드의 필요성을 줄이거나 없애는 것을 목표로 하고 있습니다.
Virpax Pharmaceuticals (NASDAQ: VRPX) a annoncé des résultats positifs d'une étude de recherche de dosage sur des minipigs pour Probudur, leur formulation liposomale de bupivacaïne à action prolongée pour la gestion de la douleur. L'étude a évalué la tolérance de Probudur dans un modèle de guérison de plaies incisionnelles, tous les minipigs montrant une tolérance positive et aucun effet indésirable. Les études précliniques ont démontré un contrôle de la douleur pouvant durer jusqu'à 96 heures, avec des modèles de rats montrant une analgésie pendant jusqu'à cinq jours et des études in vitro montrant la libération de bupivacaïne pendant jusqu'à six jours. Probudur vise à fournir un soulagement immédiat et prolongé de la douleur tout en réduisant ou en éliminant le besoin d'opioïdes après une intervention chirurgicale.
Virpax Pharmaceuticals (NASDAQ: VRPX) gab positive Ergebnisse aus einer Dosisfindungsstudie mit Minischweinen für Probudur, ihre langwirksame liposomale Bupivacain-Formulierung zur Schmerzbehandlung, bekannt. Die Studie bewertete die Toleranz von Probudur in einem Modell zur Heilung von Einschnittwunden, wobei alle Minischweine eine positive Toleranz zeigten und keine Nebenwirkungen auftraten. Präklinische Studien zeigten eine Schmerzbehandlung, die bis zu 96 Stunden anhielt, wobei Rattenmodelle eine Analgesie von bis zu fünf Tagen zeigten und In-vitro-Studien die Freisetzung von Bupivacain über bis zu sechs Tage demonstrierten. Probudur zielt darauf ab, sofortige und langfristige Schmerzlinderung zu bieten und gleichzeitig den Bedarf an postoperativen Opioiden zu reduzieren oder zu beseitigen.
- All minipigs demonstrated positive tolerance to Probudur with no adverse effects
- Preclinical studies showed extended pain control duration of up to 96 hours
- In vitro studies demonstrated sustained bupivacaine release for up to six days
- Product has potential to reduce or eliminate post-surgical opioid use
- Product still in early development phase, pending IND application
- No human clinical trial data available yet
Insights
The successful DRF study in minipigs represents a critical milestone in Probudur's development pathway. The demonstration of positive tolerance without adverse effects significantly de-risks the safety profile of this long-acting liposomal bupivacaine formulation. The preclinical data showing 96-hour to 5-day analgesic effects is particularly noteworthy, as it far exceeds current post-surgical pain management options.
For a micro-cap company with a market cap of just
The DRF study was conducted to evaluate the tolerance of Probudur in an incisional wound healing model in minipigs. Probudur was injected locally into the tissue surrounding the incision area. All of the minipigs demonstrated positive tolerance to Probudur and no adverse effects were noted. The development program for Probudur continues to support the Company’s belief that Probudur has the potential to provide both immediate and sustained pain relief at the incisional area.
“These positive study results in our pharmacokinetics and safety studies for Probudur and continue to demonstrate both immediate relief as well as sustained relief at the wound site,” stated Jatinder Dhaliwal, Chief Executive Officer of Virpax. “The completion of these studies brings us another step closer to filing our Investigational New Drug Application (IND) for Probudur.”
Probudur is being developed to achieve the overall goal of safe and effective pain control during the perioperative period and 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 preclinical studies, 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.
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
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Investor Contact:
info@virpaxpharma.com
Source: Virpax Pharmaceuticals, Inc.
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