Cholera is an acute diarrheal illness caused by infection of the intestine with the bacterium Vibrio cholerae

霍乱是由霍乱弧菌感染肠道引起的急性腹泻病

Jaguar intends to pursue a Tropical Disease Priority Review Voucher, under FDA's financial incentive program, to develop NP-300 for this indication

美洲虎打算根据FDA的财务激励计划，寻求热带病优先审核凭证，为此适应症开发NP-300

SAN FRANCISCO, CA / ACCESSWIRE / September 12, 2023 / Napo Pharmaceuticals, Inc. (Napo), a Jaguar Health (NASDAQ:JAGX) (Jaguar) family company, today announced that it has submitted a grant application to the National Institute of Allergy and Infectious Diseases (NIAID) for funding to support Napo's Phase I study of NP-300, the company's 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..

美国加利福尼亚州旧金山/ACCESSWIRE/2023年9月12日/美洲虎健康（纳斯达克：JAGX）（美洲虎）家族公司Napo制药公司（Napo）今天宣布已向国家研究所提交拨款申请过敏和传染病（NIAID）供资支持Napo对NP-300的I期研究，该公司的新型药物候选药物，用于缓解和治疗中度至重度腹泻，伴或不伴抗菌治疗，细菌，病毒和寄生虫感染，包括霍乱弧菌（引起霍乱的细菌）。。

'I am very pleased that this grant application has been filed,' said Michael K. Guy, DVM, PhD, Napo's Vice President of Preclinical and Nonclinical Studies. 'We look forward to the day when NP-300 may be available to provide symptomatic relief and treatment of dehydrating diarrhea from acute infections such as that with cholera.'.

“我非常高兴这个拨款申请已经提交，”Napo临床前和非临床研究副总裁Michael K.Guy博士说我们期待着NP-300可用于缓解和治疗急性感染（如霍乱）脱水腹泻的症状。

As announced, Napo's Investigational New Drug (IND) application for NP-300 was activated by the U.S. Food and Drug Administration (FDA) in September 2022. In support of the IND application filing, the company received partial financial support for certain IND-enabling preclinical toxicity studies from NIAID.

如宣布的那样，Napo的NP-300研究性新药（IND）申请于2022年9月由美国食品和药物管理局（FDA）启动。为了支持IND申请申请，该公司获得了来自NIAID的某些IND的临床前毒性研究的部分财务支持。

NIAID is part of the National Institutes of Health..

NIAID是美国国立卫生研究院的一部分。。

Although cholera is an orphan indication in the US, it is estimated that, worldwide, 1.3 to 4 million cholera cases and 21,000 to 143,000 cholera-related deaths occur each year, according to the Centers for Disease Control and Prevention of the U.S. Department of Health & Human Services. Approximately one in 10 infected persons will have severe disease characterized by profuse watery diarrhea, vomiting, and leg cramps.

虽然霍乱是美国的一个孤儿指征，但据美国卫生部疾病控制和预防中心估计，全世界每年发生130至400万例霍乱病例和21000至143000例霍乱相关死亡病例。人类服务。大约十分之一的感染者会患有以大量水样腹泻，呕吐和腿部痉挛为特征的严重疾病。

In these people, rapid loss of body fluids leads to dehydration and shock. Without treatment, death can occur within hours. Cholera is now endemic in many countries outside the U.S. The largest cholera outbreak in recorded history occurred recently in Yemen. According to Oxfam, the number of cholera cases in Yemen in 2019 was the second largest ever recorded in a country in a single year, surpassed only by the numbers in Yemen in 2017..

在这些人中，体液的快速流失会导致脱水和休克。没有治疗，死亡可能会在几小时内发生。霍乱现在在美国以外的许多国家流行。有记录以来最大的霍乱爆发发生在也门。据Oxfam称，2019年也门霍乱病例数是一年来该国第二大记录，仅超过2017年也门人数。。

NP-300 is a novel oral drug product that is sustainably derived from the Croton lechleri tree, the same source as that for Napo's crofelemer drug product, and is planned to be developed under the FDA's Botanical Guidance. As stated on the FDA's website, crofelemer is currently one of only two drugs that have been approved under the FDA's Botanical Guidance definition of a botanical drug product..

NP-300是一种新型口服药物，可持续来源于Croton lechleri树，与Napo的crofelemer药品来源相同，计划在FDA的植物指导下开发。正如FDA网站上所述，crofelemer目前是FDA植物药物产品植物学指导定义批准的仅有的两种药物之一。。

Upon completion of the requisite development activities to support the New Drug Application (NDA) and subsequent approval of NP-300 by the FDA for the symptomatic relief and treatment of diarrhea from cholera, the Company intends to pursue a Tropical Disease Priority Review Voucher, under the FDA's financial incentive program, to develop NP-300 for this indication.

在完成必要的开发活动以支持新药申请（NDA）并随后获得FDA批准NP-300用于霍乱腹泻的症状缓解和治疗后，本公司打算根据热带病优先审查凭证FDA的财务激励计划，为此适应症开发NP-300。

Priority review vouchers are transferable, and in past transactions by other companies have sold for values ranging from $67 million to $350 million, which provides for a potential immediate return on investment upon approval of NP-300 for the cholera-related diarrhea indication..

优先审查凭证可以转让，过去其他公司的交易销售额从6700万美元到3.5亿美元不等，这可以在NP-300批准霍乱相关性腹泻适应症后立即获得投资回报。。

About the Jaguar Health Family of Companies

关于美洲虎健康家族的公司

Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, and bowel incontinence.

美洲虎健康公司（美洲虎）是一家商业阶段制药公司，专注于为患有胃肠道不适的人和动物开发可持续衍生自雨林地区植物的新型专有处方药，特别是与肠道过度活动有关，其中包括慢性衰弱性腹泻，紧迫性和肠失禁。

Jaguar family company Napo Pharmaceuticals focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Napo Pharmaceuticals' crofelemer drug product candidate is the subject of the OnTarget study, an ongoing pivotal Phase 3 clinical trial for preventive treatment of chemotherapy-induced overactive bowel (CIOB) in adults with cancer on targeted therapy.

美洲虎家族公司Napo Pharmaceuticals专注于开发和商业化人体处方药，以便在多种复杂疾病状态下对被忽视的胃肠道症状进行必要的支持性护理和管理。Napo Pharmaceuticals的crofelemer候选药物是OnTarget研究的主题，OnTarget研究是一项正在进行的关键性3期临床试验，用于预防性治疗靶向治疗癌症成人化疗引起的过度活动性肠道（CIOB）。

Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan and/or rare diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp.

美洲虎家族公司Napo Therapeutics是一家意大利公司美洲虎，于2021年在意大利米兰成立，专注于扩大欧洲的crofelemer接入范围，特别针对孤儿和/或罕见疾病。美洲虎动物健康是美洲虎的商标。Magdalena Biosciences，由美洲虎和灯丝健康公司组建的合资企业。

that emerged from Jaguar's Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications..

来自美洲虎的Entheogen Therapeutics Initiative（ETI）的是专注于开发用于心理健康适应症的植物的新型处方药。。

For more information about Jaguar Health, please visit https://jaguar.health. For more information about Napo Pharmaceuticals, visit www.napopharma.com. For more information about Napo Therapeutics, visit napotherapeutics.com. For more information about Magdalena Biosciences, visit magdalenabiosciences.com..

有关美洲虎健康的更多信息，请访问https://jaguar.health.有关Napo制药的更多信息，请访问www.napopharma.com。有关Napo治疗的更多信息，请访问napotherapeutics.com。有关Magdalena Biosciences的更多信息，请访问magdalenabiosciences.com。。

Forward-Looking Statements

前瞻性声明

Certain statements in this press release constitute 'forward-looking statements.' These include statements regarding Jaguar's expectation that NP-300 will be developed under the FDA's Botanical Guidance, and Jaguar's expectation that the company will pursue a Tropical Disease Priority Review Voucher related to the proposed cholera-related diarrhea indication for NP-300.

本新闻稿中的某些陈述构成“前瞻性陈述”其中包括关于美洲虎期望NP-300将根据FDA的植物指导开发的声明，以及美洲虎期望该公司将寻求与NP-300建议的霍乱相关腹泻适应症相关的热带病优先审查凭证。

In some cases, you can identify forward-looking statements by terms such as 'may,' 'will,' 'should,' 'expect,' 'plan,' 'aim,' 'anticipate,' 'could,' 'intend,' 'target,' 'project,' 'contemplate,' 'believe,' 'estimate,' 'predict,' 'potential' or 'continue' or the negative of these terms or other similar expressions.

在某些情况下，您可以通过“可能”，“将会”，“应该”，“期望”，“计划”，“目标”，“预期”，“可能”，“打算”，“目标”，“项目”，“考虑”，“相信”，“估计”，“预测”，“潜在”或“继续”或这些术语或其他类似表达式的否定。

The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control.

本版本中的前瞻性陈述仅是预测。美洲华的这些前瞻性陈述主要基于其目前对未来事件的期望和预测。这些前瞻性陈述仅在本版本发布之日起发言，并受到若干风险，不确定性和假设的约束，其中一些风险，不确定性和假设无法预测或量化，其中一些风险，不确定性和假设超出美洲华的控制范围。

Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise..

除适用法律要求外，无论是由于任何新信息，未来事件，更改情况或其他原因，美洲华均不计划公开更新或修改此处包含的任何前瞻性声明。。

Contact:

联系方式：

hello@jaguar.health

hello@jaguar.health

Jaguar-JAGX

捷豹JAGX

SOURCE: Jaguar Health, Inc.

来源：美洲虎健康有限公司。

View source version on accesswire.com:

在AccessWire.com上查看源版本：

https://www.accesswire.com/783046/napo-pharmaceuticals-a-jaguar-health-family-company-submits-funding-application-to-national-institute-of-allergy-and-infectious-diseases-for-development-of-np-300-drug-candidate-for-cholera-related-diarrhea

https://www.accesswire.com/783046/napo-pharmaceuticals-a-jaguar-health-family-company-submits-funding-application-to-national-institute-of-allergy-and-infectious-diseases-for-development-of-np-300-drug-candidate-for-cholera-related-diarrhea