Click here to view interview video
Paramount near-term activities include planned October 2024 commercial launch of FDA-approved oral mucositis prescription product Gelclair® and results from independent, investigator-initiated trials of crofelemer for rare diseases
SAN FRANCISCO, CA / ACCESSWIRE / September 4, 2024 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar") today announced that a new Innovators with Jane King video interview of Lisa Conte, Jaguar's founder, president, and CEO, is available and can be viewed by clicking here.
"Our paramount near-term activities are our planned October 2024 commercial launch of the FDA-approved oral mucositis prescription product Gelclair in the U.S. and progressing our rare disease development business," said Conte.
Jaguar, with strong leadership and participation from Jaguar family companies Napo Pharmaceuticals and Napo Therapeutics, is supporting multiple investigator-initiated proof-of-concept (POC) studies of crofelemer for the rare disease indications of microvillus inclusion disease (MVID) and short bowel syndrome with intestinal failure (SBS-IF) in the US, EU, and Middle East/North Africa (MENA) regions, with results expected by the end of 2024 and throughout 2025. Additionally, the company expects to enroll first patients for two global phase 2 studies for these same indications - MVID and SBS-IF - in Q4 2024. Enrollment in the POC study of crofelemer in Abu Dhabi in pediatric patients with MVID or SBS-IF is expected to begin shortly, with results expected in Q4 2024.
Conte continued, "In accordance with the guidelines of specific EU countries, published data from POC investigations and phase 2 studies in such rare diseases could support early patient access to crofelemer for these debilitating conditions in those countries. Additionally, we are continuing our analysis of our pivotal phase 3 OnTarget trial of crofelemer for prophylaxis of cancer therapy-related diarrhea (CTD). As announced, we are collaborating with our clinical and scientific advisers to evaluate the significance of the clinically meaningful results identified in patients with breast and lung cancer in the initial data from OnTarget, as we plan to engage in discussions with the FDA to explore the possible pathway of approval to make crofelemer available to breast and lung cancer patients for CTD."
About the Jaguar Health Family of Companies
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, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals (Napo) focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Napo's crofelemer is FDA-approved under the brand name Mytesi® for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. 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. that emerged from Jaguar's Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications.
For more information about:
Jaguar Health, visit https://jaguar.health
Napo Pharmaceuticals, visit www.napopharma.com
Napo Therapeutics, visit napotherapeutics.com
Magdalena Biosciences, visit magdalenabiosciences.com
Visit the Make Cancer Less Shitty patient advocacy program at makecancerlessshitty.com and on X, Facebook & Instagram
Forward-Looking Statements
Certain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that it will begin the commercial launch in October 2024 for Gelclair, Jaguar's expectation that the company may engage in discussions with the FDA after evaluating the significance of the clinical outcome signals from the OnTarget trial, Jaguar's expectation that an approval pathway may exist to make crofelemer available to breast and lung cancer patients for CTD, the company's expectation that results from investigator-initiated and IND proof-of-concept studies of crofelemer for MVID and SBS with intestinal failure will be available by the end of 2024 and throughout 2025, the company's expectation, that in accordance with the guidelines of specific EU countries, published data from clinical investigations of crofelemer in MVID and SBS could support early patient access to crofelemer for these conditions in those countries, and the company's expectation that two Jaguar-sponsored global phase 2 clinical trials of crofelemer for intestinal failure associated with MVID or SBS will begin enrolling patients in Q4 2024. 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. 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 several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. 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.
Contact:
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SOURCE: Jaguar Health, Inc.
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