BioAegis Therapeutics has received Fast Track designation from the US Food and Drug Administration (FDA) for its lead candidate, recombinant human plasma gelsolin (rhu-pGSN), aimed at treating acute respiratory distress syndrome (ARDS).

BioAegis Therapeutics 公司的主打候选药物重组人血浆凝溶胶蛋白 (rhu-pGSN) 获得了美国食品药品监督管理局 (FDA) 的快速通道资格，该药物旨在治疗急性呼吸窘迫综合征 (ARDS)。

ARDS is a critical respiratory condition characterised by severe lung inflammation and fluid build-up, often requiring intensive care. It affects over 500,000 individuals annually in the United States alone and accounts for around 10% of all ICU admissions. Despite its high mortality rate—estimated at 40%—there are currently no approved pharmacological treatments for the condition, highlighting a significant unmet medical need..

急性呼吸窘迫综合征（ARDS）是一种严重的呼吸系统疾病，其特征是严重的肺部炎症和积液，通常需要重症监护。仅在美国，每年就有超过50万人受到影响，并占所有重症监护病房（ICU）入院人数的约10%。尽管其死亡率高达40%，但目前尚无获批的药物治疗方法，凸显了这一领域显著未满足的医疗需求。

The designation is intended to accelerate the development of treatments for serious conditions with limited existing therapies.

该指定旨在加速针对现有疗法有限的严重疾病的治疗开发。

Recombinant plasma gelsolin is based on a naturally occurring immune regulatory protein, which plays a key role in restoring immune balance without compromising the body’s defence mechanisms. BioAegis is currently advancing a global Phase 2b trial involving 600 patients to assess the safety and efficacy of rhu-pGSN in individuals with moderate to severe ARDS (NCT05947955)..

重组血浆凝溶胶蛋白基于一种天然存在的免疫调节蛋白，这种蛋白在恢复免疫平衡的同时，不会损害机体的防御机制。BioAegis目前正在推进一项全球性的二期b阶段试验，涉及600名患者，以评估重组人血浆凝溶胶蛋白在中重度急性呼吸窘迫综合征（ARDS）患者中的安全性和有效性（NCT05947955）。

The FDA Fast Track designation allows for more frequent communication with the regulatory body and can lead to a quicker review process. It may also open the door for rhu-pGSN to be accessed through the FDA’s Expanded Access or Compassionate Use programmes, potentially offering a treatment option to patients outside of clinical trials..

FDA的快速通道资格允许与监管机构进行更频繁的沟通，并可能加快审查进程。它还可能为rhu-pGSN通过FDA的扩大使用或同情使用计划提供机会，从而可能为临床试验之外的患者提供一种治疗选择。

The Fast Track status is expected to support the timely advancement of rhu-pGSN, offering hope for a new treatment option in an area with few alternatives.

快速通道地位预计将支持rhu-pGSN的及时进展，为这一替代方案极少的领域提供了新治疗选择的希望。

Source: globenewswire.com

来源：globenewswire.com