/PRNewswire/ -- Renibus Therapeutics® ('Renibus'), announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to veverimer for the treatment of anti-glomerular basement membrane disease (anti-GBM), an ultra-rare life-threatening condition characterized by acute renal failure associated with the presence of auto-immune antibodies with affinity for the glomerular basement membrane.

/PRNewswire/ -- Renibus Therapeutics®（“Renibus”）宣布，美国食品药品监督管理局 (FDA) 已授予veverimer用于治疗抗肾小球基底膜病（anti-GBM）的孤儿药资格。这是一种超罕见的致命性疾病，特征是急性肾衰竭，并与针对肾小球基底膜的自身免疫抗体相关。

'Ultra-rare life-threatening conditions, including anti-GBM and several other forms of glomerular and tubulointerstitial kidney diseases, can be aggressive and challenging to treat effectively with current therapies,' said

“包括抗GBM和几种其他形式的肾小球和肾小管间质疾病在内的超罕见危及生命的病症，可能具有侵袭性，并且用现有疗法很难有效治疗，”

Bhupinder Singh M.D

辛格医生，布平德尔

., Chief Medical Officer of Renibus.  'This Orphan Drug Designation further underscores the potential of veverimer to offer a significant advantage beyond drugs currently used to treat kidney disease, and we look forward to advancing this asset in the clinic.'

Renibus首席医学官表示：“这一孤儿药资格进一步凸显了veverimer在治疗肾病方面可能比现有药物更具显著优势，我们期待在临床中推进这一资产。”

The Orphan Drug Designation program is intended to encourage the development of products for diseases that affect fewer than 200,000 individuals in

孤儿药指定计划旨在鼓励开发用于影响少于20万个体的疾病的产品。

the United States

美国

. With this designation Renibus is eligible for certain incentives, such as tax credits for clinical trials, exemption from user fees, and a potential 7 years of market exclusivity upon approval.

通过这一指定，Renibus有资格获得某些激励措施，例如临床试验的税收抵免、用户费用的豁免，以及在批准后可能长达7年的市场独占期。

Richard Zager

理查德·扎格

, Senior Vice President of Translational Research of Renibus, commented, 'Veverimer markedly suppresses ammoniagenisis and associated activation of the complement cascade, which are key mediators of anti-GBM disease and other complement mediated renal diseases.  We are continuing to evaluate the potential of veverimer to address these diseases of high unmet medical need.'.

Renibus转化研究高级副总裁评论道：“Veverimer显著抑制氨生成和补体级联反应的相关激活，这些是抗GBM病和其他补体介导的肾脏疾病的关键介质。我们正在继续评估veverimer在应对这些高度未满足医疗需求的疾病方面的潜力。”

About Renibus Therapeutics

关于Renibus Therapeutics

Renibus is a clinical stage biopharmaceutical company dedicated to treating, improving, and extending patients' lives by developing products to prevent disease progression, improve outcomes and protect against organ damage associated with cardio, renal and metabolic diseases.

Renibus是一家临床阶段的生物制药公司，致力于通过开发预防疾病进展、改善结果和保护心脏、肾脏和代谢疾病相关器官损伤的产品来治疗、改善和延长患者的生命。

Renibus' lead first-in class combination drug therapy is RBT-1 (stannic protoporfin / iron sucrose), a single dose IV drug that is given over 1-2 hours, 24-48 hours prior to patients undergoing elective cardiac and/or valve surgery.  RBT-1 has just completed enrollment in a Phase 3 pivotal trial (called PROTECT) measuring its primary objective to reduce the risk of post operative complications and improve outcomes following cardiac surgery.

Renibus公司的领先首创新药组合疗法是RBT-1（锡原卟啉/蔗糖铁），这是一种单剂量静脉注射药物，给药时间为1-2小时，在患者接受择期心脏和/或瓣膜手术前的24-48小时使用。RBT-1刚刚完成了一项名为PROTECT的3期关键试验的受试者招募，该试验的主要目标是降低术后并发症的风险并改善心脏手术后的预后。

The drug has been granted FDA Breakthrough and Fast Track Designations by the Division of Cardiology and Nephrology at the FDA..

该药物已获得FDA心脏病学和肾病学部门授予的FDA突破性疗法和快速通道资格。

Veverimer is an oral, non-absorbed hydrochloric acid binder that has been granted Orphan Drug Designation for the treatment of anti-glomerular basement membrane disease. Renibus is also evaluating veverimer's potential use for the treatment of other renal diseases.

Veverimer 是一种口服、不被吸收的盐酸结合剂，已被授予用于治疗抗肾小球基底膜病的孤儿药资格。Renibus 也在评估 Veverimer 在治疗其他肾脏疾病方面的潜在用途。