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Investigator-Initiated Trial of Jaguar Health’s Crofelemer Yields Positive Results for Functional Diarrhea

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Jaguar Health announced that a third-party, investigator-initiated study of its plant-based drug, crofelemer, showed positive results for treating functional diarrhea. The study revealed that twice-daily oral doses of crofelemer significantly reduced abdominal pain and improved stool consistency compared to a placebo. Functional diarrhea, a chronic condition affecting 4.7% of adults globally, currently lacks effective treatments. Napo Pharmaceuticals, a subsidiary of Jaguar, is planning to submit an abstract of the study to a peer-reviewed journal. Crofelemer is derived from the red bark sap of the Croton lechleri tree, harvested sustainably in the Amazon Rainforest.

Positive
  • Twice-daily oral administration of crofelemer led to statistically meaningful reductions in abdominal pain and discomfort.
  • Study showed improved stool consistency for functional diarrhea patients compared to placebo.
  • Publication of study results in a peer-reviewed journal could enhance credibility and awareness.
  • Crofelemer is a novel, plant-based medicine with sustainable harvesting practices.
Negative
  • The study was investigator-initiated, which may raise questions about the scale and oversight of the research.
  • No information on the size of the study or its long-term efficacy was provided.
  • Functional diarrhea, though prevalent, is only one of many gastrointestinal disorders, limiting the market scope.

Jaguar Health's recent announcement regarding positive results from an investigator-initiated study of crofelemer for functional diarrhea is quite impactful from a clinical standpoint. The study indicates that crofelemer significantly improves abdominal pain, discomfort and stool consistency in patients with functional diarrhea, a condition that currently lacks effective treatments. This not only fills an unmet medical need but also opens avenues for crofelemer to become a recognized treatment option in gastroenterology. Functional diarrhea affects approximately 4.7% of the global population and having a novel, plant-based treatment could greatly enhance the quality of life for these patients. Investors should note the potential market size and the growing demand for effective gastrointestinal treatments.

From a market perspective, the positive clinical trial results for crofelemer could significantly impact Jaguar Health's valuation and market positioning. The gastrointestinal drugs market is substantial and growing, driven by increasing awareness and diagnosis of gastrointestinal disorders. Successful clinical outcomes for crofelemer can potentially lead to increased adoption, especially given it is plant-based and aligns with the current trend towards natural and sustainable treatments. Moreover, the sustainable harvesting and fair trade practices underscore a strong corporate social responsibility narrative, which can enhance brand loyalty and attract ethical investors.

SAN FRANCISCO, CA / ACCESSWIRE / May 28, 2024 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar") family company Napo Pharmaceuticals ("Napo") today announced that the results of a third-party, investigator-initiated study of crofelemer, Napo's novel plant-based prescription drug, show that twice daily oral administration of crofelemer led to a statistically meaningful reduction of abdominal pain and discomfort and improved stool consistency in functional diarrhea patients when compared to placebo.

The study investigators are preparing an abstract on the study for submission to a peer-reviewed journal later this year.

Functional diarrhea, defined as chronic diarrhea for more than 6 months, is a common diagnosis without effective treatments. It is a functional gastrointestinal disorder, meaning that it occurs without any other known signs of disease, injury, or structural problem. A global survey by the Rome Foundation of 73,000 adults in 33 countries found that functional diarrhea had a prevalence of 4.7%.1

Crofelemer is a novel, oral plant-based medicine purified from the red bark sap, also referred to as "dragon's blood," of the medicinal Croton lechleri tree in the Amazon Rainforest. Napo has established a sustainable harvesting program, under fair trade practices, for crofelemer to ensure a high degree of quality, ecological integrity, and support for Indigenous communities.

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 innovative, patient-centric therapeutic solutions for essential supportive care and the management of neglected side effects across complicated disease states. Napo's goal is to redefine what is possible in supportive care, providing hope and improving outcomes for patients worldwide. Napo's crofelemer drug product candidate is the subject of the OnTarget study, a pivotal Phase 3 clinical trial for preventive treatment of chemotherapy-induced overactive bowel (CIOB) in adults with cancer on targeted 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 Jaguar on LinkedIn: https://www.linkedin.com/company/jaguar-health/
Visit Jaguar on X: https://twitter.com/Jaguar_Health
Visit Jaguar on Instagram: https://www.instagram.com/jaguarhealthcommunity/

Forward-Looking Statements

Certain statements in this press release constitute "forward-looking statements." These include statements regarding the expectation that the study investigators will submit an abstract on the study to a peer-reviewed journal in 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 a number of 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.

1 The Global Prevalence of Functional Gastrointestinal Disorders - Results of the First Global Study

Contact:

hello@jaguar.health
Jaguar-JAGX

SOURCE: Jaguar Health, Inc.



View the original press release on accesswire.com

FAQ

What were the results of the investigator-initiated trial of crofelemer?

The trial showed that twice-daily oral doses of crofelemer significantly reduced abdominal pain and improved stool consistency in functional diarrhea patients compared to a placebo.

What is crofelemer, and how is it used?

Crofelemer is a plant-based prescription drug derived from the red bark sap of the Croton lechleri tree. It is used to treat functional diarrhea by reducing abdominal pain and improving stool consistency.

What is functional diarrhea, and how common is it?

Functional diarrhea is a chronic gastrointestinal disorder characterized by diarrhea lasting more than six months without a known disease or injury. It affects approximately 4.7% of adults globally.

What is the significance of the study results for Jaguar Health's stock (JAGX)?

Positive trial results could enhance the credibility of crofelemer, potentially boosting investor confidence and impacting Jaguar Health's stock (JAGX) positively.

What are the sustainability practices associated with crofelemer?

Crofelemer is harvested sustainably from the Croton lechleri tree under fair trade practices, ensuring high quality, ecological integrity, and support for Indigenous communities in the Amazon Rainforest.

Jaguar Health, Inc.

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About JAGX

jaguar health, inc. is a commercial stage natural-products pharmaceuticals company focused on developing novel, sustainably derived gastrointestinal products for both human prescription use and animals on a global basis. our wholly-owned subsidiary, napo pharmaceuticals, inc., focuses on developing and commercializing proprietary human gastrointestinal pharmaceuticals for the global marketplace from plants used traditionally in rainforest areas. our mytesi® (crofelemer) product is approved by the u.s. fda for the symptomatic relief of noninfectious diarrhea in adults with hiv/aids on antiretroviral therapy. canalevia™ is our lead animal prescription drug candidate, intended for treatment of various forms of diarrhea in dogs. equilevia™ is jaguar’s non-prescription product for total gut health in equine athletes. to read our full social media policy, please visit https://jaguar.health/social-media-policy/