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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

捷豹健康子公司納波製藥公司宣佈FDA激活了NP-300的研究新藥(IND)申請,NP-300是一種對症狀緩解和治療霍亂和其他病原體腹瀉的新藥候選藥物
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.

亞洲網加利福尼亞州聖何塞10月24日電捷豹健康公司(納斯達克代碼:JAGX)(以下簡稱:捷豹公司)的全資子公司納波製藥公司(以下簡稱納波)今天宣佈,美國食品和藥物管理局(FDA)激活了針對納波NP-300的研究新藥(IND)申請。納波NP-300是一種新藥產品,適用於對症狀緩解和治療中重度腹瀉,同時或不同時進行抗菌治療,包括細菌、病毒和寄生蟲感染霍亂弧菌,引起霍亂的細菌。

"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."

捷豹總裁兼首席執行官麗莎·孔特説:“我們很高興從FDA那裏聽到,他們已經完成了對我們用於NP-300的IND申請的審查,並得出結論,納波可能會繼續進行該藥物擬議的I期臨牀試驗。在I期試驗完成後,當我們的開發團隊擁有必要的資源和帶寬來啟動額外的所需試驗時,公司將準備啟動我們霍亂相關腹瀉臨牀開發計劃的下一階段。”我們感謝美國國家過敏和傳染病研究所(NIAID)為支持NP-300臨牀前項目提供的部分資金支持。

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