Tuesday, September 26, 2023

Jaguar Health Expects to Release Top Line Results of Crofelemer’s Phase 3 Clinical Trial

Last updated Friday, July 21, 2023 10:16 ET

Jaguar Health expects to release top line results in October for its Phase 3 clinical trial of crofelemer to treat diarrhea in people undergoing targeted cancer therapy.

San Francisco, California, 07/21/2023 / SubmitMyPR /

Jaguar Health, a pharmaceutical company focused on developing novel, plant-based medicines for gastrointestinal distress, has announced that it is nearing the conclusion of the phase 3 clinical trial for its antidiarrheal drug crofelemer (trade name Mytesi) as a prophylactic for cancer therapy-related diarrhea.

Crofelemer is an organic, plant-based, non-opioid orally administered drug derived from the sap of the Croton lechleri tree, also known as dragon’s blood, which is commonly found in South America, especially in Peru, Colombia, Ecuador, and Bolivia. In 2012, crofelemer was approved by the FDA for use in treating non-infectious diarrhea in adults living with HIV/AIDS, on antiretroviral therapy.

Sap from the Croton lechleri tree in Peru

The top line data from crofelemer's phase 3 clinical trial for cancer therapy-related diarrhea is expected to come out at the end of October 2023, and achieving statistical significance in the trial on the primary endpoint is key to applying for approval from the FDA for this particular application. The results of the clinical trial are expected to be presented at the San Antonio Breast Cancer Symposium in December and at the American Society of Clinical Oncology's 2024 Annual Meeting. The trial incorporates patients with solid tumors that are on around 25 types of targeted therapies that are indicated to have a more than 50% chance to cause diarrhea.

Aside from being an issue of comfort and dignity, diarrhea can also affect cancer patients' ability to take their medications. It is estimated that around 40% of patients either reduce or go off their life-saving chemotherapy because of diarrhea, which, of course, can have a direct impact on their cancer care outcome.

According to Jaguar Health Founder, President, and CEO Lisa Conte, diarrhea is the most common side effect for people on targeted cancer therapy, which need to be taken long-term, sometimes for years on end or for life. Crofelemer is a locally acting chloride channel ion modulator that normalizes the ion flow, water flow, and the dehydration level of the patient's gastrointestinal tract, and it can be used chronically as a prophylactic, preventing patients from having diarrhea. Its absorption from the gut into the bloodstream is minimal, reducing the possibility of drug interactions.

Crofelemer's mechanism of action is different from conventional antimotility drugs such as loperamide that may cause constipation. Conte says the trial's endpoints are focused on producing formed stools of normal consistency and not the absence of stool, which may be indicative of constipation.

Conte adds that crofelemer's approval will result in a paradigm change in treating diarrhea as a side effect of targeted cancer therapy. “It will be similar to what cancer patients experience with chemotherapy-induced nausea and vomiting. When a patient goes on a chemotherapy protocol they are prophylactically given the anti-nausea medication so they won't have to deal with it in the first place, and that's the tradition that we are following with how we have designed the clinical trial for crofelemer for cancer therapy-related diarrhea.”

Established in 2013, Jaguar Health uses traditional knowledge as a means for more efficient drug discovery and development. It works with Indigenous healers to identify various plants that may have medicinal properties, bringing back around 100 plants a year. It then applies the scientific method with Western-trained physicians and ethnobotanists to prioritize which plants could be pharmaceutically relevant and determine the chemicals responsible for the therapeutic effect. Its products undergo the same regulatory process as all prescription drugs, including rigorous clinical trials.

Jaguar Health also established Healing Forest Conservancy, a nonprofit organization that recognizes the intellectual contributions of Indigenous knowledge and seeks to return benefits from product profits to collaborating countries and cultural groups. It has reinvested a huge amount in reforestation, sustainability, potable water supply, and education for Indigenous communities in Peru, where Jaguar Health sources most of the Croton lechleri it uses.

“If approved, crofelemer will greatly benefit patients who chronically need to take targeted cancer therapies. For them, having to deal with even grade 1 or 2 side effects everyday for the rest of their life can be unbearable. We liken these side effects to pebbles in the shoe. Patients need to deal with diarrhea, nausea, neuropathy, muscle pain, fatigue, and many more. While the definitive cure to cancer has yet to be found, we want to take one pebble out of the patient's shoes by managing chronic diarrhea,” Conte says.

Media contact:

Name: Peter Hodge

Email:[email protected]

Original Source of the original story >> Jaguar Health Expects to Release Top Line Results of Crofelemer’s Phase 3 Clinical Trial