The U.S. Food and Drug Administration (FDA) activated the investigational new drug (IND) application filed by Napo Pharmaceuticals, Inc., a wholly-owned subsidiary of Jaguar Health Inc. (NASDAQ:JAGX). The IND is for crofelemer (Mytesi®), a supposedly symptomatic reliever of cancer therapy-related diarrhea (CTD) in adult patients and prophylaxis. A majority of the patients suffering from this illness are usually under a targeted therapy treatment of solid tumors.
The Potential of Mytesi in Managing Cancer Treatment-Related Diarrhea
Statistics from the Centers for Disease Control and Prevention (CDC) show that the cancer patient population receiving chemotherapy in the US is about 650,000 people. This is on an annual basis and from an outpatient oncology clinic. After chemotherapy a significant number experience diarrhea, which is followed by dehydration and potential infections. Another section of the population does not abide by the treatment.
With Mytesi, a plant-based, and antidiarrheal medicine, this is likely to pass; thanks to its novel mechanism of action. To control diarrhea in cancer patients, drug dose reductions, or drug holidays is recommended during their therapies. Reduced frequency of watery stools is automatically a symptomatic relief of diarrhea, and with this comes observance of the therapeutic dosing.
‘’…In addition to tumor burden reduction, the adoption and/or continued use of targeted cancer therapies is also related to the ability of patients to tolerate their cancer therapies…’’ Jaguar’s president and CEO, Lisa Conte, commented.
Preclinical Services from the National Institute Of Allergy and Infectious Diseases (“NIAID”)
Jaguar has initiated a 28-day preclinical toxicology and safety study in rats. This will support the development of lechlemer, a plant-based anti-secretory drug candidate for Napo Pharmaceuticals. The success of the drug candidate is receiving massive support from NIAID under its suite of preclinical services.
Lechlemer is believed to be a representation of a long-term pipeline opportunity for multiple gastrointestinal diseases and on a global basis. It is also suitable in resource-constrained countries. Thus the success of the 28-day toxicity and safety study will be a great milestone to the company. It will also accelerate the Investigational New Drug (IND) application