Investing News NetworkFebruary 15, 2024Designation Based on Pre-Clinical Data and Initial Clinical Data from the Company's MAvERIC-Pilot Phase II StudyThis is a Designated News Release.Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ('Cardiol' or the 'Company'), a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, announces that the United States Food and Drug Administration ('FDA') has granted Orphan Drug Designation ('ODD') for the Company's lead small molecule drug candidate for the treatment of pericarditis, which includes recurrent pericarditis.

投资新闻网2024年2月15日根据该公司MAvERIC试点II期研究的临床前数据和初始临床数据进行设计这是一个指定的新闻稿。Cardiol Therapeutics Inc.（纳斯达克：CRDL）（TSX:CRDL）（“Cardiol”或“公司”）是一家临床阶段生命科学公司，专注于用于治疗心脏病的抗炎和抗纤维化疗法的研究和临床开发，宣布美国食品和药物管理局（FDA）已授予孤儿药名称（“ODD”）用于该公司治疗心包炎（包括复发性心包炎）的主要小分子候选药物。

CardiolRx™ is currently in Phase II clinical trials for recurrent pericarditis and acute myocarditis.'The FDA's decision was based on pre-clinical data combined with initial clinical data from the Company's MAvERIC-Pilot Phase II study,' commented Dr. Andrew Hamer, Cardiol Therapeutics' Chief Medical Officer and Head of Research & Development.

CardiolRx™目前正在进行复发性心包炎和急性心肌炎的II期临床试验。”Cardiol Therapeutics首席医疗官兼研发主管安德鲁·哈默（AndrewHamer）博士评论道，FDA的决定是基于临床前数据以及该公司MAvERIC试点II期研究的初步临床数据。

'This designation reinforces the potential of CardiolRx™ to improve the lives of patients suffering with recurrent pericarditis, a debilitating heart disease associated with symptoms that adversely affect quality of life and physical activity.' The FDA grants ODD to a drug or biological product to prevent, diagnose, or treat a rare disease or conditions that affect fewer than 200,000 people in the United States.

“这种名称增强了CardiolRx™改善复发性心包炎患者生活的潜力，复发性心包炎是一种使人衰弱的心脏病，其症状会对生活质量和体力活动产生不利影响。”美国食品和药物管理局（FDA）授予一种药物或生物制品ODD，用于预防、诊断或治疗影响美国不到20万人的罕见疾病或病症。

ODD provides benefits to sponsors including potential seven-year marketing exclusivity, exemptions from certain FDA fees, and tax credits for qualified clinical trials. Products with ODD may also qualify for accelerated regulatory review via Fast Track, Breakthrough Therapy, or Priority Review designations.

ODD为赞助商提供了好处，包括潜在的七年营销排他性，免除某些FDA费用，以及合格临床试验的税收抵免。ODD产品也有资格通过快速通道、突破疗法或优先审查指定进行加速监管审查。

MAvERIC-Pilot (NCT05494788) is a Phase II open-.

MAvERIC Pilot（NCT05494788）是第二阶段开放的。