Virpax Receives Positive Probudur™ Results for Dose Range Study Moves Towards Next Steps in IND
Virpax Pharmaceuticals (NASDAQ: VRPX) has announced positive results from a beagle dog dose range finding (DRF) study for Probudur, their long-acting liposomal bupivacaine formulation designed for post-surgical pain management.
The study demonstrated that beagle dogs showed positive tolerance to Probudur with no adverse effects, with doses up to 90 mg/kg being well-tolerated. This marks a significant step toward their Investigational New Drug (IND) application.
Probudur, a local anesthetic that blocks pain signals by binding to sodium channels, has shown promising results in preclinical studies:
- Pain control lasting at least 96 hours
- Analgesia for up to 5 days in rat incisional models
- Slow bupivacaine release lasting up to 6 days in vitro
Virpax Pharmaceuticals (NASDAQ: VRPX) ha annunciato risultati positivi da uno studio di determinazione della dose (DRF) condotto su cani beagle per Probudur, la loro formulazione liposomiale di bupivacaina a lunga durata d'azione progettata per la gestione del dolore post-chirurgico.
Lo studio ha dimostrato che i cani beagle hanno mostrato una buona tolleranza a Probudur senza effetti avversi, con dosi fino a 90 mg/kg ben tollerate. Questo rappresenta un passo significativo verso la loro richiesta di Nuovo Farmaco Investigativo (IND).
Probudur, un anestetico locale che blocca i segnali di dolore legandosi ai canali sodici, ha mostrato risultati promettenti in studi preclinici:
- Controllo del dolore che dura almeno 96 ore
- Analgesia per un massimo di 5 giorni in modelli di incisione su ratti
- Rilascio lento di bupivacaina che dura fino a 6 giorni in vitro
Virpax Pharmaceuticals (NASDAQ: VRPX) ha anunciado resultados positivos de un estudio de determinación de rango de dosis (DRF) en perros beagle para Probudur, su formulación liposomal de bupivacaína de acción prolongada diseñada para el manejo del dolor postquirúrgico.
El estudio demostró que los perros beagle mostraron una buena tolerancia a Probudur sin efectos adversos, con dosis de hasta 90 mg/kg bien toleradas. Esto marca un paso significativo hacia su solicitud de Nuevo Medicamento en Investigación (IND).
Probudur, un anestésico local que bloquea las señales de dolor al unirse a los canales de sodio, ha mostrado resultados prometedores en estudios preclínicos:
- Control del dolor que dura al menos 96 horas
- Analgesia de hasta 5 días en modelos de incisión en ratas
- Liberación lenta de bupivacaína que dura hasta 6 días in vitro
Virpax Pharmaceuticals (NASDAQ: VRPX)는 Probudur에 대한 비글 개의 용량 범위 탐색(DRF) 연구에서 긍정적인 결과를 발표했습니다. Probudur는 수술 후 통증 관리를 위해 설계된 장기 작용 리포좀 부피바카인 제제입니다.
연구 결과 비글 개들이 Probudur에 대해 부작용 없이 긍정적인 내성을 보였으며, 최대 90 mg/kg의 용량이 잘 견디는 것으로 나타났습니다. 이는 그들의 새로운 의약품 신청(IND) 신청을 향한 중요한 단계입니다.
Probudur는 나트륨 채널에 결합하여 통증 신호를 차단하는 국소 마취제로, 전임상 연구에서 유망한 결과를 보였습니다:
- 최소 96시간 지속되는 통증 조절
- 쥐 절개 모델에서 최대 5일 동안의 진통 효과
- 시험관 내에서 최대 6일 동안 지속되는 느린 부피바카인 방출
Virpax Pharmaceuticals (NASDAQ: VRPX) a annoncé des résultats positifs d'une étude de détermination de la plage de doses (DRF) réalisée sur des chiens beagle pour Probudur, leur formulation liposomale de bupivacaïne à action prolongée conçue pour la gestion de la douleur post-chirurgicale.
L'étude a démontré que les chiens beagle ont montré une bonne tolérance à Probudur sans effets indésirables, avec des doses allant jusqu'à 90 mg/kg bien tolérées. Cela marque une étape significative vers leur demande de Nouveau Médicament Expérimental (IND).
Probudur, un anesthésique local qui bloque les signaux de douleur en se liant aux canaux sodiques, a montré des résultats prometteurs dans des études précliniques :
- Contrôle de la douleur durant au moins 96 heures
- Analgésie pendant jusqu'à 5 jours dans des modèles d'incision sur des rats
- Libération lente de bupivacaïne durant jusqu'à 6 jours in vitro
Virpax Pharmaceuticals (NASDAQ: VRPX) hat positive Ergebnisse aus einer Dosisbereichsbestimmungsstudie (DRF) mit Beagle-Hunden für Probudur bekannt gegeben, ihre langanhaltende liposomale Bupivacain-Formulierung zur Schmerzbehandlung nach chirurgischen Eingriffen.
Die Studie zeigte, dass Beagle-Hunde eine positive Toleranz gegenüber Probudur aufwiesen, ohne unerwünschte Nebenwirkungen, wobei Dosen von bis zu 90 mg/kg gut vertragen wurden. Dies stellt einen bedeutenden Schritt in Richtung ihrer Antragstellung für ein Investigational New Drug (IND) dar.
Probudur, ein Lokalanästhetikum, das Schmerzsignale blockiert, indem es an Natriumkanäle bindet, hat in präklinischen Studien vielversprechende Ergebnisse gezeigt:
- Schmerzkontrolle, die mindestens 96 Stunden anhält
- Analgesie von bis zu 5 Tagen in Ratten-Inzisionsmodellen
- Langsame Freisetzung von Bupivacain, die bis zu 6 Tage in vitro anhält
- Successful completion of dose range finding study with positive tolerance results
- Preclinical data shows extended pain control duration of 4-6 days
- Progress toward IND application milestone
- Still in early preclinical stage, requiring further studies before potential FDA approval
- No human trial data available yet
The DRF study was conducted to evaluate the tolerance of Probudur when administered by subcutaneous (SC) injection to beagle dogs in a dose escalating manner. All the dogs in the DRF study demonstrated positive tolerance to Probudur and no adverse effects were noted. The results of this study suggest that doses of LBL100 up to 90 mg/kg are well tolerated by beagle dogs.
Probudur is being developed to achieve the overall goal of safe and effective pain control during the perioperative period and to significantly reduce or eliminate the need for opioids after surgery in approved indications. Probudur is a local anesthetic that binds to the sodium channels, 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 (5) days and in vitro studies demonstrating a slow release of bupivacaine that lasted for up to six (6) days.
About Virpax Pharmaceuticals, Inc.
Virpax is developing branded, non-addictive pain management products candidates using its proprietary technologies to optimize and target drug delivery. Virpax is initially seeking the
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Source: Virpax Pharmaceuticals, Inc.
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