CORTE MADERA, Calif.--(BUSINESS WIRE)--Ophirex, Inc., a Public Benefit Corporation developing an oral treatment to address the unmet medical needs of snakebite victims globally, today announced that BMJ Global Health has published data from the company’s BRAVO trial evaluating oral varespladib. Varespladib is a small synthetic molecule that directly inhibits secretory phospholipase A2 (sPLA2), an enzyme that is present in more than 95% of all snake venoms.

加利福尼亚州科尔特·马德拉（商业新闻短讯）--Ophirex，Inc.，一家开发口服治疗以解决全球毒蛇咬伤受害者未满足的医疗需求的公益公司，今天宣布，BMJ Global Health发布了该公司BRAVO试验评估口服varespladib的数据。。

The oral form is being developed as an early intervention treatment for patients and has potential to be the first-ever field therapy for snakebite envenoming, providing treatment at “time-of-bite.”.

口服形式正在开发中，作为患者的早期干预治疗，有可能成为蛇咬毒液的首次现场治疗，在“咬伤时”提供治疗。

The article in BMJ Global Health details results from BRAVO (Broad-spectrum Rapid Antidote: Varespladib Oral for snakebite), a multi-center, randomized, double-blind, placebo-controlled, Phase 2 study designed to evaluate the safety, tolerability and efficacy of oral varespladib. It enrolled 95 patients in the U.S.

《BMJ Global Health details》上的文章来自BRAVO（广谱快速解毒剂：瓦雷斯普拉迪口服治疗蛇咬伤），这是一项多中心，随机，双盲，安慰剂对照的2期研究，旨在评估口服瓦雷斯普拉迪的安全性，耐受性和有效性。它在美国招募了95名患者。

and India who were administered either varespladib or placebo in conjunction with the standard of care, which included antivenom in 93 of the 95 patients..

和印度，他们与标准治疗一起服用了varespladib或安慰剂，其中95名患者中有93名使用了抗蛇毒血清。。

“The BRAVO trial set out to do something no one has done before. In addition to being the first study to evaluate a direct toxin inhibitor for the treatment of snakebites, BRAVO was the first clinical trial to enroll patients bitten by any species of snake across two continents, including some of the world’s deadliest species,” said Timothy Platts-Mills, M.D., MSc, Chief Medical Officer of Ophirex.

Ophirex首席医学官医学博士蒂莫西·普拉茨·米尔斯（TimothyPlatts Mills）说：“BRAVO试验旨在做一些以前没有人做过的事情。除了是第一项评估用于治疗毒蛇咬伤的直接毒素抑制剂的研究外，BRAVO还是第一个招募跨两大洲被任何种类蛇咬伤的患者的临床试验，其中包括一些世界上最致命的物种。”。

“While this Phase 2 study did not meet its primary endpoint, a promising signal of benefit was seen in the group of patients receiving treatment within five hours of a bite, reinforcing varespladib’s potential as an early treatment option and suggesting initial utility as a field treatment.”.

“虽然这项2期研究没有达到其主要终点，但在咬伤后5小时内接受治疗的患者组中观察到了一个有希望的益处信号，增强了varespladib作为早期治疗选择的潜力，并建议作为现场治疗的初始效用。”。

For the early treatment subgroup, clinically important differences were observed across important outcomes, such as lower illness severity over the first week, higher rates of complete recovery, and improved patient-reported function in patients receiving varespladib. Results from the BRAVO trial also suggest that varespladib is safe and well tolerated for the treatment of snakebite, adding to a robust body of safety data for this therapeutic candidate..

对于早期治疗亚组，在重要结果中观察到临床上重要的差异，例如在第一周内疾病严重程度较低，完全恢复率较高，以及接受varespladib治疗的患者报告的功能改善。。。

“Antivenom, the current standard of care for snakebites, has several limitations, including the need to match antivenom to specific snake types, the risk of anaphylaxis, and the need to be administered intravenously in a medical setting. Yet we know that 75% of deaths due to venomous snakebites occur before the victim ever reaches the hospital.

“抗蛇毒血清是目前治疗毒蛇咬伤的标准，有几个局限性，包括需要将抗蛇毒血清与特定类型的蛇相匹配，过敏反应的风险以及需要在医疗环境中静脉注射。然而，我们知道75%的毒蛇咬伤死亡发生在受害者到达医院之前。

Even in those patients who survive, early treatment leads to better outcomes,” said Charles J. Gerardo, M.D., Professor and Chair for the Department of Emergency Medicine at Duke University and BRAVO trial investigator. 'These data represent an encouraging advancement for patients bitten by snakes with the potential to fill a significant unmet need as a real world, early treatment before a patient reaches a healthcare facility.”.

杜克大学（Duke University）急诊医学系教授兼主席兼BRAVO试验研究员查尔斯·杰拉尔多（CharlesJ.Gerardo）医学博士说：“即使是那些存活下来的患者，早期治疗也会带来更好的结果。”这些数据代表了被蛇咬伤的患者取得的令人鼓舞的进步，有可能在患者到达医疗机构之前进行早期治疗，以满足现实世界中尚未满足的重大需求。”。

“India has the greatest snakebite burden in the world, and 97% of snakebite deaths in the country occur in rural areas far from medical care and current treatments. A novel therapeutic molecule such as oral varespladib in addition to standard of care has the potential to enable treatment at the time of bite or en route to a more advanced facility and could be an important improvement in care for patients and medical systems alike,” said Dr.

“印度是世界上毒蛇咬伤负担最大的国家，该国97%的毒蛇咬伤死亡发生在远离医疗和当前治疗的农村地区。除了标准治疗外，一种新型的治疗分子，如口服varespladib，有可能在咬伤时或在前往更先进的设施的途中进行治疗，可能是对患者和医疗系统护理的重要改进，”Dr。

Suneetha D.K., Professor and Head of Internal Medicine, Mysore Medical College and Research Institute, Mysuru and a BRAVO trial investigator..

Suneetha D.K.，迈苏鲁迈索尔医学院和研究所教授兼内科主任，BRAVO试验调查员。。

“These findings support Ophirex’s vision to advance varespladib initially as an oral field treatment available at the time of the bite. We look forward to applying key learnings from this clinical trial to ongoing studies that address the long unmet need for a field treatment,” said Matthew R. Lewin, MD, PhD, Chief Scientific Officer and Founder of Ophirex, who first published the concept of this molecule as a field treatment in snakebite in 2016..

“这些发现支持了Ophirex的愿景，即首先将varespladib作为咬伤时可用的口服现场治疗方法。我们期待着将这项临床试验的关键经验应用于正在进行的研究中，以解决长期未满足的现场治疗需求，”Ophirex首席科学官兼创始人Matthew R.Lewin博士说，他于2016年首次将这种分子的概念作为蛇咬伤的现场治疗方法发表。。

The manuscript, titled “Oral Varespladib for the Treatment of Snakebite Envenoming in India and the United States (BRAVO): A Phase 2 Randomised Clinical Trial,” is available online here.

该手稿题为“口服Varespladib治疗印度和美国毒蛇咬伤（BRAVO）：2期随机临床试验”，可在此处在线获得。

About Ophirex

关于Ophirex

Ophirex is a Delaware Public Benefit Corporation developing a first-of-its-kind oral treatment to address the global unmet need of venomous snakebites. Worldwide, there are approximately 500,000 cases of snakebite envenoming resulting in death or permanent disability each year. While antivenom has been the standard of care to treat these bites for more than 100 years, it can only be administered in a hospital setting.

Ophirex是特拉华州的一家公益公司，开发了第一种口服治疗方法，以解决全球未满足的毒蛇咬伤需求。全世界每年约有500000例毒蛇咬伤病例导致死亡或永久残疾。虽然抗蛇毒血清是治疗这些叮咬的标准治疗方法已有100多年的历史，但它只能在医院环境中使用。

This poses a significant challenge as 75% of deaths from venomous snakebites occur before the victim can reach appropriately equipped medical care. Ophirex is advancing its investigational treatment, varespladib, as a broad-spectrum treatment for snakebite in both oral and intravenous formulations with human and veterinary applications.

这构成了一个重大挑战，因为75%的毒蛇咬伤死亡发生在受害者能够获得适当装备的医疗保健之前。Ophirex正在推进其研究性治疗，varespladib，作为口服和静脉注射制剂中蛇咬的广谱治疗，用于人类和兽医应用。

Ideally taken immediately following a bite, it is intended to provide a bridge to survival between bite and arrival to the hospital. If successful, this early intervention is anticipated to result in improved overall outcomes for patients at risk of death and long-term disability from snakebite. The company has presented some of the BRAVO data at scientific conferences.

理想情况下，咬伤后立即服用，旨在为咬伤和到达医院之间的生存提供桥梁。如果成功，预计这种早期干预将改善毒蛇咬伤死亡和长期残疾风险患者的总体预后。该公司在科学会议上展示了一些BRAVO数据。

Ophirex is concluding a separate Phase 2 study to evaluate IV-to-oral dosing of varespladib for snakebite envenoming based on learnings from BRAVO..

Ophirex正在完成一项单独的第二阶段研究，根据BRAVO的经验，评估静脉注射到口服varespladib治疗毒蛇咬伤的效果。。

For more information, visit www.ophirex.com.

有关更多信息，请访问www.ophirex.com。