BERWYN, Pa.--(BUSINESS WIRE)--Virpax Pharmaceuticals, Inc. (Nasdaq: VRPX) ("Virpax" or the "Company"), 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 from a minipig Dose Range Finding ("DRF") study for Probudur. Probudur is the company's long-acting liposomal bupivacaine formulation injected at a wound site to provide both immediate and extended pain relief.
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.
賓夕法尼亞州伯溫--(美國商業資訊)--Virpax Pharmicals, Inc.(納斯達克股票代碼:VRPX)(「Virpax」 或 「公司」)是一家專門開發用於疼痛管理、創傷後應激障礙、中樞神經系統(CNS)疾病和抗病毒屏障適應症的非成癮性產品的公司,今天公佈了針對Probudur的minipig劑量範圍測定(「DRF」)研究的結果。Probudur 是該公司在傷口部位注射的長效脂質體布比卡因配方,可立即和長期緩解疼痛。
進行DRF研究的目的是評估微型豬切口傷口癒合模型中Probudur的耐受性。Probudur 被局部注射到切口區域周圍的組織中。所有小豬都表現出對Probudur陽性的耐受性,沒有發現任何不良反應。Probudur的開發計劃繼續支持公司的信念,即Probudur有可能立即和持續地緩解切口部位的疼痛。
Virpax首席執行官Jatinder Dhaliwal表示:「這些積極的研究促成了我們對Probudur的藥代動力學和安全性研究,並繼續證明傷口部位可以立即緩解和持續緩解。」「這些研究的完成使我們離提交Probudur的研究性新藥申請(IND)又近了一步。」
Probudur的開發旨在實現圍手術期安全有效的疼痛控制的總體目標,並在批准的適應症下顯著減少或消除手術後對阿片類藥物的需求。Probudur 是一種局部麻醉劑,可與鈉離子通道結合,防止疼痛信號到達大腦。在臨床前研究中,Probudur顯示出持續時間長達至少96小時的疼痛控制,大鼠切口模型顯示鎮痛時間長達五天,體外研究表明,布比卡因的緩慢釋放持續了長達六天。
關於 Virpax 製藥
Virpax正在使用其專有技術開發品牌的非成癮性疼痛管理候選產品,以優化和靶向藥物輸送。Virpax最初正在尋求美國食品藥品管理局批准兩種採用兩種不同專利藥物遞送平台的候選處方藥。Probudur 是一種單次注射脂質體布比卡因配方,正在開發用於治療術後疼痛,而 Envelta 是一種鼻內分子包膜腦啡肽配方,正在開發用於治療急性和慢性疼痛,包括與癌症相關的疼痛。Virpax還利用其鼻內分子包膜技術(MET)開發另一種候選處方產品NobrXiol,該藥物是爲鼻腔輸送一種用於治療罕見小兒癲癇的藥用級大麻二酚(CBD)而開發的。Virpax爲其兩種候選處方藥簽訂了具有競爭力的合作研發協議(CRadaS),一項與美國國立衛生研究院(NIH),另一項與國防部(DOD)簽訂。Virpax還在爲兩種非處方藥候選產品尋找合作伙伴:AnqLar,其開發目的是抑制由流感或SARS-CoV-2引起的病毒複製;Epoladerm,一種局部使用雙氯芬酸噴霧薄膜配方,正在開發用於治療與骨關節炎相關的疼痛。