Could This Company's Gastrointestinal Drug Be A Powerful Pill For People And Animals With Chronic, Debilitating Diarrhea?

San Francisco-based Jaguar Health, Inc. JAGX, a commercial-stage pharmaceuticals company, says it is focused on developing novel, plant-based, non-opioid and sustainably derived prescription medicines for people and animals with gastrointestinal (GI) diseases, including chronic, debilitating diarrhea.

The company reports developing and commercializing proprietary plant-based human pharmaceuticals from plants harvested responsibly from rainforest areas through its wholly-owned subsidiary, Napo Pharmaceuticals (Napo).

Currently, Jaguar’s focus is crofelemer, a plant-based anti-diarrheal drug. The drug is at the core of the company’s pipeline development activities on the clinical front.

Enrollment is ongoing for Napo’s OnTarget pivotal Phase 3 clinical trial of crofelemer for prophylaxis of diarrhea in adult cancer patients receiving targeted therapy.

Napo aims to complete 256 patient enrollments in this trial by the first half of 2023. There are plans to expand the trial to clinical sites outside the U.S.

The successful completion of this pivotal trial would result in a supplemental new drug application filing with the Food and Drug Administration (FDA) for crofelemer for this indication.

To eliminate safety and manufacturing issues, which often lead to drug application failure, Napo states it has taken much care in communication with the FDA in designing and executing the OnTarget trial, the final clinical step to bring crofelemer to human cancer patients suffering from cancer therapy-related diarrhea (CTD).

In 2021, Jaguar formed Napo Therapeutics, a Milan, Italy-based corporation focused on expanding crofelemer access in Europe. Napo Therapeutics' initial focus is on clinical development and future registration in Europe of crofelemer for debilitating orphan disease target indications starting with short bowel syndrome (SBS) and congenital diarrheal disorders (CDD).

SBS & CDD Bites By Numbers

  • Both SBS and CDD patients with intestinal failure typically require parenteral nutrition up to 20 hours a day, seven days a week to survive, at tremendous costs. Accompanying medical complications can significantly impact quality of life.
  • The ability to decrease the parenteral nutrition requirement by even 20% would provide a profound medical and quality of life improvement for these patients.
  • Despite limited treatment options, the global SBS market exceeded $568 million in 2019 and is expected to reach $4.6 billion by 2027, according to a report by Vision Research Reports.

In an industry that has players like Bayer AG BAYN, Abbott Laboratories ABT, and Johnson & Johnson JNJ, Napo Therapeutics believes its drug may have the potential to decrease the parenteral nutrition requirement by 20% to improve these patients’ lives.

Crofelemer is also the active ingredient in Canalevia®-CA1, Jaguar’s prescription drug for treating chemotherapy-induced diarrhea (CID) in dogs.

Canalevia-CA1 received conditional approval from the FDA in December 2021 and became commercially available to veterinarians and their clients in the U.S. to provide comfort and relief to canine patients at the end of April 2022.

As with human cancer patients, dogs go off their disease-modifying chemotherapy approximately 40% of the time due to diarrhea, meaning these dogs cannot complete their therapeutic dose of chemotherapy because of diarrhea.

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