NEWS
U.S. Investigator-Initiated Trial (IIT) to Evaluate Jaguar Health's Crofelemer for Short Bowel Syndrome with Intestinal Failure (SBS-IF) Begins
Friday, 6th December at 8:30 am
The study is one of five clinical efforts - three IIT proof-of-concept studies and two Phase 2 studies - of crofelemer for the rare disease indications of SBS-IF and/or microvillus inclusion disease (MVID), an ultrarare congenital diarrheal disorder, in the US, EU, and/or Middle East/North Africa (MENA) regions; availability of IIT proof-of-concept results potentially in Q2 2025
Crofelemer, Jaguar's novel plant-based prescription drug, has been granted Orphan Drug Designation by the FDA and the European Medicines Agency for both SBS-IF and MVID
SAN FRANCISCO, CA / ACCESSWIRE / December 6, 2024 / Jaguar Health, Inc. (NASDAQ: JAGX) (Jaguar) family company Napo Pharmaceuticals (Napo) today announced that an independent IIT in the U.S. to evaluate the efficacy and safety of crofelemer, Jaguar's novel plant-based anti-diarrheal prescription drug, for the rare disease indication of short bowel syndrome with intestinal failure (SBS-IF) in adults has begun. An overview of the study can be viewed on the ClinicalTrials.gov website.
Lisa Conte, Jaguar's founder, president, and CEO, said, "This study is one of five clinical efforts - three IIT proof-of-concept studies and two Phase 2 studies - of crofelemer for the rare disease indications of SBS-IF and/or MVID in the US, European Union, and/or MENA regions. These studies are evaluating a novel powder formulation of crofelemer for oral solution - which is different from the FDA-approved oral formulation of crofelemer available for people living with HIV/AIDS. Dosing of the first patient in each of these five studies is expected to occur throughout December 2024 and Q1 2025, with availability of IIT proof-of-concept results potentially in Q2 2025. In accordance with the guidelines of specific EU countries, published data from clinical investigations in SBS-IF and MVID could support reimbursed early patient access to crofelemer for these debilitating conditions in those countries."
Friday, 6th December at 8:30 am
The study is one of five clinical efforts - three IIT proof-of-concept studies and two Phase 2 studies - of crofelemer for the rare disease indications of SBS-IF and/or microvillus inclusion disease (MVID), an ultrarare congenital diarrheal disorder, in the US, EU, and/or Middle East/North Africa (MENA) regions; availability of IIT proof-of-concept results potentially in Q2 2025
Crofelemer, Jaguar's novel plant-based prescription drug, has been granted Orphan Drug Designation by the FDA and the European Medicines Agency for both SBS-IF and MVID
SAN FRANCISCO, CA / ACCESSWIRE / December 6, 2024 / Jaguar Health, Inc. (NASDAQ: JAGX) (Jaguar) family company Napo Pharmaceuticals (Napo) today announced that an independent IIT in the U.S. to evaluate the efficacy and safety of crofelemer, Jaguar's novel plant-based anti-diarrheal prescription drug, for the rare disease indication of short bowel syndrome with intestinal failure (SBS-IF) in adults has begun. An overview of the study can be viewed on the ClinicalTrials.gov website.
Lisa Conte, Jaguar's founder, president, and CEO, said, "This study is one of five clinical efforts - three IIT proof-of-concept studies and two Phase 2 studies - of crofelemer for the rare disease indications of SBS-IF and/or MVID in the US, European Union, and/or MENA regions. These studies are evaluating a novel powder formulation of crofelemer for oral solution - which is different from the FDA-approved oral formulation of crofelemer available for people living with HIV/AIDS. Dosing of the first patient in each of these five studies is expected to occur throughout December 2024 and Q1 2025, with availability of IIT proof-of-concept results potentially in Q2 2025. In accordance with the guidelines of specific EU countries, published data from clinical investigations in SBS-IF and MVID could support reimbursed early patient access to crofelemer for these debilitating conditions in those countries."
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