Jaguar Health Supports Evaluation of FDA-Approved Crofelemer to Address GI Side Effects of GLP-1 and Other Weight Loss Therapies: Files Patent Application with USPTO

Rhea-AI Summary

Jaguar Health (NASDAQ:JAGX) has filed a provisional patent application with the USPTO for crofelemer to address gastrointestinal side effects associated with GLP-1 and other weight loss therapies. Crofelemer, FDA-approved under the brand name Mytesi for HIV-related diarrhea, has shown significant benefits in improving GI symptoms including diarrhea, abdominal pain, and bloating.

The application targets the growing market of GLP-1 therapies, projected to reach $56 billion globally by 2025 and grow at a 21% CAGR to $322 billion by 2034. GI disorders are reported in 40-70% of patients using GLP-1 receptor agonists, with rates up to 85% in some cases, often leading to dose limitations or discontinuations.

Positive

• Patent application could expand crofelemer's market to include the rapidly growing GLP-1 therapy sector
• Target market projected to reach $322 billion by 2034 with 21% CAGR
• Addresses a significant medical need affecting up to 85% of GLP-1 therapy patients

Negative

• No clinical trial data yet available for crofelemer's effectiveness with GLP-1 therapies
• Patent application is still pending, with no guarantee of approval

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Gastrointestinal disorders are the most frequently reported adverse effects during clinical trials of GLP-1 agonists; GI adverse events usually develop in 40-70% of treated patients, and have been reported in up to 85%

Crofelemer, approved by the FDA under the brand name Mytesi^® for HIV-related diarrhea, has demonstrated a significant benefit in improving gastrointestinal symptoms, including diarrhea, abdominal pain and discomfort, incontinence, bloating and constipation, when studied in populations with HIV-related diarrhea, cancer therapy-related diarrhea, and IBS

Crofelemer could have a significant supportive impact on GLP-1 therapies, one of the fastest growing classes of drugs, estimated to be a $56 billion global market in 2025 and projected to grow at a CAGR of 21% to $322 billion 2034¹

SAN FRANCISCO, CA / ACCESS Newswire / January 29, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) family company Napo Pharmaceuticals (Napo) today announced Napo's filing of a broad defining provisional patent application with the U.S. Patent and Trademark Office (USPTO) for crofelemer, Jaguar's novel plant-based FDA-approved gastrointestinal normalizing prescription drug, to mitigate the gastrointestinal side effects associated with glucagon-like peptide-1 (GLP-1) receptor agonists and antagonists, together with other incretin-based therapies including glucose-dependent insulinotropic polypeptide (GIP) agonists and antagonists, and glucagon-agonist drugs.

GLP-1 and GIP drugs are analogs for incretin hormones that are released by the gut and bind to receptors in the brain and gastrointestinal tract, suppressing appetite, which consequently leads to body weight loss.

"Gastrointestinal disorders were the most frequently reported adverse effects during clinical trials and real-world experience of GLP-1 receptor agonists, ² such as semaglutide, tirzepatide, and liraglutide. GI adverse events usually develop in 40-70% of patients treated with GLP-1 receptor agonists, although they have sometimes been reported in up to 85%, ³ which can lead to dose limitations or dose discontinuations. There are also numerous investigative agents, including incretins and combinations with GLP-1 drugs, both as receptor agonists and antagonists, all of which are associated with significant GI side effects, often in a dose-dependent manner. Our IP strategy includes claims for both commercialized obesity drugs and incretin-based therapies in development. Crofelemer, approved by the U.S. Food and Drug Administration under the brand name Mytesi for HIV-related diarrhea, has demonstrated a significant benefit in improving gastrointestinal symptoms, including diarrhea, abdominal pain and discomfort, incontinence, bloating and constipation, when studied in populations with HIV-related diarrhea, cancer therapy-related diarrhea, and IBS," said Lisa Conte, Jaguar's founder, president, and CEO. "Crofelemer has a safety profile supporting its chronic utilization, and we are excited about crofelemer's possible potential to normalize specific GI side effects associated with obesity therapies, address patient comfort, and help patient's stay on their therapy."

About Crofelemer
Crofelemer is a novel, oral plant-based prescription medicine purified from the red bark sap, also referred to as "dragon's blood," of the 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 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

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Forward-Looking Statements
Certain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that crofelemer could have a significant supportive impact on GLP-1 therapies, and Jaguar's expectation that crofelemer may have the potential to normalize specific GI side effects associated with obesity therapies, address patient comfort, and help patient's stay on their therapy. 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.

¹ GLP-1 Analogues Market Outlook: Rapid Growth at 21.3% CAGR to Surpass USD 322.85 Billion by 2034 | PMR

² Sun F, Chai S, Yu K, Quan X, Yang Z, Wu S, Zhang Y, Ji L, Wang J, Shi L. Gastrointestinal adverse events of glucagon-like peptide-1 receptor agonists in patients with type 2 diabetes: a systematic review and network meta-analysis. Diabetes Technol Ther. 2015;17(1):35-42. doi: 10.1089/dia.2014.0188

³ J Clin Med. 2022 Dec 24;12(1):145. Clinical Recommendations to Manage Gastrointestinal Adverse Events in Patients Treated with GLP-1 Receptor Agonists: A Multidisciplinary Expert Consensus

CONTACT:
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Jaguar-JAGX

SOURCE: Jaguar Health, Inc.

View the original press release on ACCESS Newswire

FAQ

What is the projected market size for GLP-1 therapies that JAGX is targeting?

The GLP-1 therapy market is estimated to reach $56 billion globally by 2025 and is projected to grow at a 21% CAGR to $322 billion by 2034.

How common are GI side effects in patients using GLP-1 therapies that JAGX's crofelemer aims to treat?

GI adverse events typically occur in 40-70% of patients treated with GLP-1 receptor agonists, with reports showing rates up to 85% in some cases.

What symptoms can JAGX's crofelemer potentially address in GLP-1 therapy patients?

Crofelemer has shown benefits in improving gastrointestinal symptoms including diarrhea, abdominal pain and discomfort, incontinence, bloating, and constipation.

What is the current FDA approval status of JAGX's crofelemer?

Crofelemer is currently FDA-approved under the brand name Mytesi for HIV-related diarrhea.

What patent protection has JAGX filed for crofelemer's use with GLP-1 therapies?

Jaguar Health has filed a broad defining provisional patent application with the USPTO for crofelemer to mitigate GI side effects associated with GLP-1 and other incretin-based therapies.