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Jaguar Health Announces Completion of Key Milestone in Process of Establishing Indena S.p.A. as a Reliable Approved Crofelemer Manufacturer
Milestone supports the expansion of manufacturing volume required for potential additional indications for crofelemer, including cancer therapy-related
About this update from Jaguar Health, Inc.
[{"type":"text","content":"Milestone supports the expansion of manufacturing volume required for potential additional indications for crofelemer, including cancer therapy-related diarrheaCrofelemer API (active pharmaceutical ingredient) manufactured by Indena can now be used by Jaguar for development workPatient enrollment expected to complete in Q2 2023 for company's pivotal Phase 3 OnTarget clinical trial of crofelemer for prophylaxis of diarrhea in adult cancer patients receiving targeted therapySAN FRANCISCO, CA / ACCESSWIRE / January 25, 2023 / Jaguar Health, Inc. (NASDAQ:JAGX) today announced that the required procedure of registering the source of the active pharmaceutical ingredient (API) of crofelemer with the Agenzia Italiana Del Farmaco (AIFA), the Italian Medicines Agency, has been successfully completed. Resultingly, batches of crofelemer API manufactured by Milan, Italy-based Indena S.P.A. can now be used by Jaguar for further development work.\"We are very pleased about the completion of this key milestone in the ongoing process of establishing Indena as an additional approved crofelemer manufacturer as we work to support the increased crofelemer manufacturing demand expected upon potential FDA approval of crofelemer for new indications, including approval for cancer therapy-related diarrhea (CTD),\" said David Sesin, Ph.D., Jaguar's chief manufacturing officer. \"Jaguar is honored to have had a long-standing relationship with Indena, a pioneer and world-class leader in plant-based pharmaceutical manufacturing.\"About Cancer Therapy-related DiarrheaA significant proportion of patients undergoing cancer therapy experience diarrhea, and diarrhea has the potential to cause dehydration, potential infections, and non-adherence to treatment in this population. Novel \"targeted cancer therapy\" agents, such as epidermal growth factor receptor (EGFR) antibodies and tyrosine kinase inhibitors (TKIs), with or without cycle chemotherapy agents, may cause increased electrolyte and fluid content in the gut lumen, which results in passage of loose/watery stools (i.e., diarrhea). Diarrhea has been reported as one of the most common side effects of TKIs and may result in cancer therapy drug holidays or reductions from therapeutic dose, potentially impacting patient outcome. Diarrhea is also a common side effect of some approved CDK 4/6 inhibitors.About Ind...