Bayer AG and Asklepios BioPharmaceutical, Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for the AB-1002 program.

拜耳公司和作为拜耳公司全资子公司独立运营的基因治疗公司Asklepios BioPharmaceutical，Inc.（AskBio）今天宣布，美国食品和药物管理局（FDA）已批准AB-1002计划的快速通道。

AB-1002 is an investigational one-time gene therapy that is administered to the heart with the intention of helping to promote the production of a constitutively active form of protein inhibitor 1 (I-1c) designed to block the action of protein phosphatase 1. Inhibiting the function of this protein, which is linked to congestive heart failure (CHF), could potentially lead to a therapeutic effect on the heart.1,2“The FDA Fast Track Designation for AB-1002 is an important accomplishment for the clinical development of this program and highlights our goal of bringing potentially effective treatments to patients with advanced congestive heart failure,” said Canwen Jiang, MD, PhD, Chief Development Officer and Chief Medical Officer, AskBio.

AB-1002是一种研究性一次性基因疗法，用于心脏，旨在帮助促进蛋白质抑制剂1（I-1c）的组成型活性形式的产生，旨在阻断蛋白磷酸酶1的作用。抑制这种与充血性心力衰竭（CHF）有关的蛋白质的功能，可能会对心脏产生治疗效果。1,2“FDA对AB-1002的快速通道指定是该项目临床开发的重要成就，并强调了我们为晚期充血性心力衰竭患者带来潜在有效治疗的目标，”AskBio首席开发官兼首席医疗官Canwen Jiang博士说。

“We look forward to completing our Phase II GenePHIT clinical trial, which is currently enrolling patients with severe heart failure, and are committed to exploring the full potential of AB-1002 for the treatment of this devastating disease.”The FDA Fast Track Program is designed to facilitate the development and expedite the review of new therapeutics that are intended to treat serious conditions and fill unmet medical needs.3 The purpose of the Program is to get important new therapeutics to patients earlier.3 Therapeutics that receive this designation benefit from eligibility for more frequent meetings with the FDA to discuss the development plan and, if relevant criteria are met, eligibility for Ac.

“我们期待着完成我们的II期GenePHIT临床试验，该试验目前正在招募严重心力衰竭患者，并致力于探索AB-1002治疗这种毁灭性疾病的全部潜力。”FDA快速通道计划旨在促进旨在治疗严重疾病和满足未满足医疗需求的新疗法的开发和加速审查。3该计划的目的是尽早为患者提供重要的新疗法。3获得该指定的治疗剂受益于与FDA更频繁会议的资格，以讨论开发计划，如果符合相关标准，则有资格获得Ac。