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Jaguar Health Subsidiary Napo Pharmaceuticals Announces Activation By FDA Of Investigational New Drug (IND) Application For NP-300, A Novel Drug Candidate For Symptomatic Relief And Treatment Of Diarrhea From Cholera And Other Pathogens

Jaguar Health Subsidiary Napo Pharmaceuticals Announces Activation By FDA Of Investigational New Drug (IND) Application For NP-300, A Novel Drug Candidate For Symptomatic Relief And Treatment Of Diarrhea From Cholera And Other Pathogens

捷豹健康子公司纳波制药公司宣布FDA激活了NP-300的研究新药(IND)申请,NP-300是一种对症状缓解和治疗霍乱和其他病原体腹泻的新药候选药物
Benzinga Real-time News ·  2022/09/29 08:34

Napo Pharmaceuticals, Inc. ("Napo"), the wholly-owned subsidiary of Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar" or the "Company") today announced the activation by the U.S. Food and Drug Administration (FDA) of the Investigational New Drug (IND) application for Napo's NP-300, a novel drug product candidate for the symptomatic relief and treatment of moderate-to-severe diarrhea, with or without concomitant antimicrobial therapy, from bacterial, viral and parasitic infections including Vibrio cholerae, the bacterium that causes cholera.

亚洲网加利福尼亚州圣何塞10月24日电捷豹健康公司(纳斯达克代码:JAGX)(以下简称:捷豹公司)的全资子公司纳波制药公司(以下简称纳波)今天宣布,美国食品和药物管理局(FDA)激活了针对纳波NP-300的研究新药(IND)申请。纳波NP-300是一种新药产品,适用于对症状缓解和治疗中重度腹泻,同时或不同时进行抗菌治疗,包括细菌、病毒和寄生虫感染霍乱弧菌,引起霍乱的细菌。

"We were very pleased to hear from the FDA that they have completed their review of our IND application for NP-300 and concluded that Napo may proceed with its proposed phase I clinical trial for the drug. Following the completion of the phase I trial, the Company will be positioned to initiate the next stage of our clinical development program for cholera-related diarrhea when our development team has the requisite resources and bandwidth to initiate the additional required trials," said Lisa Conte, Jaguar's president and CEO. "We are grateful for the partial financial support from the National Institute of Allergy and Infectious Diseases (NIAID) to support the NP-300 preclinical program."

捷豹总裁兼首席执行官丽莎·孔特说:“我们很高兴从FDA那里听到,他们已经完成了对我们用于NP-300的IND申请的审查,并得出结论,纳波可能会继续进行该药物拟议的I期临床试验。在I期试验完成后,当我们的开发团队拥有必要的资源和带宽来启动额外的所需试验时,公司将准备启动我们霍乱相关腹泻临床开发计划的下一阶段。”我们感谢美国国家过敏和传染病研究所(NIAID)为支持NP-300临床前项目提供的部分资金支持。

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