Jaguar Health, a pharma focused on plant-based prescription medicine, has had a rough year.
The company, dogged by sinking share prices, slumped 32% in June, capping off a 97% decline for the year. But Jaguar Health’s long-term fortunes may soon change if its first-in-class gastrointestinal drug Mytesi gains approval for a new indication to address treatment-related diarrhea in cancer patients.
Mytesi is currently approved to treat antiretroviral therapy-related diarrhea in people with HIV/AIDS and gained orphan drug designation from the FDA and the European Medicines Agency as a treatment for short bowel syndrome. The drug is also in early-stage trials for irritable bowel syndrome and inflammatory bowel disease.
“We are less than 30 days away from having the top-line results on the final pivotal phase 3 trial to expand the indication of Mytesi to cancer therapy-related diarrhea on a prophylactic basis,” said Lisa Conte, CEO, president and founder of Jaguar Health. This could open up the drug’s market to an estimated 1.1 million people taking targeted cancer therapies in 2024, a number that rises each year as survival ticks up, Conte said.
The drug discovery jungle
Jaguar Health has walked a unique path in a literal sense — its researchers have scoured the rainforest foraging for plants with medicinal potential in people and animals. Often referred to as nature’s largest medicine cabinet, plants from the rainforest have long produced a bevy of therapies, and over the past three decades, Jaguar Health has collected 2,300 plants and 3,500 plant extracts. It derived Mytesi’s main ingredient, crofelemer, from the South American Croton lechleri tree, and Magdalena Biosciences, a joint venture between Jaguar Health and Filament Health, is now exploring the plant library to develop drugs for mental health disorders.
The company’s other commercialized drug, Canalevia-CA1, treats chemo-induced diarrhea in dogs, while its human-health pipeline includes a handful of treatments in clinical development for gastro-related ailments.
Targeting an unmet cancer need
If Mytesi gains approval for the new cancer indication, it could be a game changer for patients. Researchers sometimes characterize treatment-related diarrhea as a tolerable toxicity, which makes patients living with the condition cringe, Conte said.
More than 87% of people living with HIV for a decade or more have chronic diarrhea, according to Jaguar Health, that affects their ability to work and socialize, while taxing their physical and mental health. Similar problems plague cancer patients.
As treatments have increased life expectancy for patients with metastatic cancer, quality of life has become an important consideration. Thanks to medical advances, metastatic cancer patients often live for many years and want to resume normal lives, not be chained to the house by stomach symptoms, Conte said.
Over the past three decades, Jaguar Health has collected 2,300 plants and 3,500 plant extracts.
Managing diarrhea is more than a quality-of-life issue — it’s also a significant health issue. If people don’t respond to these drugs, they may need to abandon potentially successful cancer treatments or endure hospitalizations to manage dehydration or other complications, Conte said.
Today, treatments for persistent and severe diarrhea are limited. Synthetic opioid drugs such as loperamide (Imodium) are the most common options, but they can bring risks in higher doses, such as heart rhythm problems or death, and often lead to constipation, Conte said.
The company hopes doctors will one day automatically prescribe Mytesi to prevent treatment-related diarrhea the way they currently address treatment-related nausea.
“We will be filing a supplemental NDA at the end of the year based on the top line data that comes out this month, and then pushing for a supplemental review,” Conte said.
Because the drug is already on the market and has a known safety profile, chances are favorable both for its approval and the company’s future, she says.
“I think that'll bring the company back to where it should be,” Conte said.
