Benzinga | Aug 19, 2020 08:35AM EDT

Jaguar Health Provides Updates on Investigator-Initiated Trials Of Crofelemer

Company shares updates on investigator-initiated trials of crofelemer (Mytesi(r)), a novel FDA-approved plant-based oral prescription medicine

SAN FRANCISCO, CA / ACCESSWIRE / August 19, 2020 / Jaguar Health, Inc. (NASDAQ:JAGX) today provided updates regarding ongoing investigator-initiated trials in non-HIV patient populations of crofelemer (Mytesi(r)), the novel FDA-approved plant-based oral drug developed and marketed by Jaguar's wholly-owned subsidiary, Napo Pharmaceuticals, Inc.

Updates Regarding Investigator-Initiated Trials:

Chronic Idiopathic Diarrhea in Non-HIV Adult Patients

Yield of Diagnostic Tests and Management of Crofelemer for Chronic Idiopathic Diarrhea in Non-HIV Patients: A Pilot Study

Following COVID-related delays, this single-center clinical research study in adult non-HIV patients at The University of Texas Health Science Center at Houston (UTH) has started enrolling. Full enrollment is expected to be reached by the end of 2020, and the study results are expected to be available by mid to late 2021.

Chronic idiopathic diarrhea is a common complaint of patients presenting to family practitioners and internists and is one of the most common reasons for referral to gastroenterologists. It is estimated that the prevalence of chronic idiopathic diarrhea in developed countries (including the U.S.) is approximately 3-5%. It has a significant negative effect on health-related quality of life and causes a high economic burden on patients and society. The American Gastroenterological Association Burden of Illness study (2012) showed that the estimated annual direct and indirect costs associated with chronic idiopathic diarrhea are up to $524 million per year and $136 million per year, respectively.

Functional Diarrhea in Non-HIV Adult Patients

A randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and efficacy of crofelemer in subjects with functional diarrhea

This investigator-initiated study will be conducted at a single center at Beth Israel Deaconess Medical Center, a Harvard Medical School institution in Boston. This study is expected to initiate enrollment of patients in the fourth quarter of 2020, and topline results are expected to be available in fourth quarter of 2021.

Diarrhea in HER2-positive Breast Cancer Patients

HALT-D: Diarrhea Prevention and Prophylaxis with Crofelemer in HER2 Positive Breast Cancer Patients Receiving Trastuzumab, Pertuzumab, and Docetaxel or Paclitaxel with or without Carboplatin

This is an ongoing investigator-initiated study at Georgetown University to obtain preliminary evidence of the effectiveness of crofelemer for the symptomatic relief of diarrhea in HER2-positive breast cancer patients receiving chemotherapy with trastuzumab, pertuzumab, and docetaxel or paclitaxel with or without carboplatin. The study is nearing completion of enrollment of the full cohort of patients, and subjects in the study are expected to complete treatment by the end of 2020.

The final report for this study is expected to be available in mid-2021.

Mytesi is the only oral plant-based medicine approved by the FDA for the treatment of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy and the only oral plant-based prescription medicine approved under FDA Botanical Guidance. Mytesi has a novel mechanism of action that works locally in the gut by gently and effectively modulating and normalizing the flow of water and electrolytes with minimal systemic absorption. Crofelemer comes from the Croton lechleri tree, which is responsibly and sustainably harvested in South America.