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Jaguar Health Achieves Statistically Significant Top Line Results in Study Evaluating Crofelemer for Treatment of Diarrhea Related to Targeted Cancer Therapy
Preclinical Study Results Expected to Provide Key Supportive Data for Future Clinical Investigations Evaluating Crofelemer for Treatment of Noninfectious
About this update from Jaguar Health, Inc.
[{"type":"text","content":"Preclinical Study Results Expected to Provide Key Supportive Data for Future Clinical Investigations Evaluating Crofelemer for Treatment of Noninfectious Diarrhea in Human Cancer Patients Receiving Targeted Cancer TherapySAN FRANCISCO, CA / ACCESSWIRE / August 19, 2019 / Jaguar Health, Inc. (NASDAQ:JAGX) (“Jaguar” or the “Company”) announced today that statistically significant top line results have been achieved in a key preclinical pharmacological study to evaluate the effects of crofelemer on diarrhea induced in healthy dogs by a maximally tolerated dose of a specific tyrosine kinase inhibitor (TKI) (“the Study”). The results of the Study, which was funded by a third-party cancer agent manufacturer of an FDA-approved TKI, are expected to provide additional scientific rationale and support for the use of crofelemer in providing symptomatic relief of noninfectious diarrhea in human patients receiving TKI-and/or-other targeted cancer therapy-containing regimens in future human clinical investigations. The top line results of the Study show that combined crofelemer groups demonstrated superior benefit for “responders” (p= 0.01). “We are very excited by these results, and hope to see a similar outcome in the interim data, expected to be available in the third quarter of this year, and final data, of a Phase 2 investigator initiated clinical study at Georgetown in human breast cancer patients receiving the targeted cancer therapy regimens Herceptin and Perjeta,” Lisa Conte, Jaguar’s president and CEO, stated. “Certain targeted cancer therapy agents have been reported to have 90% or higher incidence of diarrhea, which can impair the therapeutic use due to dose-reductions and/or result in discontinuation of such agents.” The Study randomized 24 healthy Beagle dogs into three parallel groups over a treatment period of 28-days dosed with the TKI and placebo or crofelemer (crofelemer 125 mg delayed-release tablets) up to four times a day. Specifically, one group of dogs received crofelemer twice daily (BID group) with the TKI; another group received crofelemer four times daily (QID group) with the TKI; and the third group received placebo capsules four times a day (placebo group) with the TKI. A key endpoint, a “responder,” was defined as any dog having","length":2810,"tagName":"div"}]