In an exclusive interview with The Fly, Jaguar Health's (JAGX) CEO Lisa Conte talked about the company, its pipeline, partnerships and much more.
PLANT DERIVED MEDICINES: Jaguar Health is a commercial-stage pharmaceutical company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, and bowel incontinence.
"At Jaguar Health, we do all drug discovery from plants that are used traditionally in tropical areas, so plant-based medicines, and it's all for prescription pharmaceuticals. What we're looking for is to discover and develop prescription pharmaceuticals, new ways of treating and curing disease with a specific focus on gastrointestinal disorders," CEO Lisa Conte explained in an exclusive interview with The Fly.
CROFELEMER: Jaguar's lead drug Crofelemer, a plant-based antidiarrheal, is FDA approved under the name Mytesi for adults with HIV/AIDS who battle digestive distress as the result of their prescription drug cocktails. Additionally, Crofelemer is undergoing a global phase 3 trial in cancer therapy-related diarrhea, has been granted orphan drug designation by the FDA and the European Medicines Agency for short bowel syndrome, and is in early-stage trials for both irritable bowel syndrome and inflammatory bowel disease.
"Now most of the company's efforts have focused on late-stage clinical development of Crofelemer to expand the indication from people living with HIV AIDS to other patient populations with very, very large, neglected needs. The most exciting thing going on in the company right now is we are literally a couple of weeks away from unblinding and revealing the results of a final pivotal Phase 3 trial to expand the indication to prophylaxis of diarrhea in cancer patients, all solid tumor cancer patients, on targeted therapy. And targeted therapy are those therapies that you see on television that people are on for years or the rest of their life in a metastatic situation, the tyrosine kinase inhibitors, the immunomodulators. So that will allow us the opportunity with those results to then file with the FDA to be able to expand the indication and what that means is the opportunity to educate and promote to get to the 1.1 million cancer patients every single year in the United States and growing that are on chemotherapy," the executive said.
AWARENESS CAMPAIGN: Jaguar Health has recently launched a social media contest on both TikTok and Instagram to raise awareness about a common condition among people with HIV that is rarely talked about – chronic and surprise diarrhea. "We have found in the current indication, HIV, that there is a bit of a stigma in talking about GI function, a bit of a stigma in talking about diarrhea. Also, people living with HIV AIDS 20 years ago had really, really horrible diarrhea as side effects of the meds. The meds have less side effects of diarrhea now, yet it's still a first side effect, and secondly there's enteropathy inflammation from having the virus in your gut for 10 years or so, long-term survivors," Conte told The fly.
ANIMAL HEALTH PORTFOLIO: Alongside the human health product portfolio, the company is also developing two products for dogs. "On the animal side, the product that is approved is Canalevia, Canalevia 001. It's Crofelemer for dogs, and it is approved for chemotherapy-induced diarrhea in dogs. And in the CVM, the Center of Veterinary Medicine of the FDA, it's what they call a conditional approval, so it was able to get out relatively very quickly, with a limited number of clinical trials because of the safety and the unmet need and the preliminary indication of activity. This is what we would call a specialty market. It's a relatively small market. It probably won't be more than a couple of million dollars. And very important to the dogs because there's about 100 million dogs in the United States, about 50% of them will get cancer. And the dynamics to the human situation are almost identical. About 40% of the time, dogs go off of their chemotherapy because of diarrhea. That's the same thing that you have in the human situation. So, while it's not our driver financially in the size and the impact of the unmet need like we have on the human situation, it is very important to the dogs and very predictive of what we're seeing in the human situation," Jaguar Health's CEO added.
BIG IMPACT: Discussing potential misconceptions about the company with The Fly, Lisa Conte said that the biggest one is probably regarding "why the value of what's going on in this company is not reflected" in the stock. "The impact can be big given the neglected need in human. Let's just take cancer, for example, that's 1.1M patients, if we look at an analogous situation of chemotherapy and just nausea and vomiting, which is prophylaxis for just the first three days of cytotoxic chemotherapy, that's like a $4 billion market around the world. We're talking about the largest side effect associated with cancer therapy, prophylaxis, all solid tumor patients, every single day for a year and a curative for the rest of their life in a metastatic situation. So huge. The product is already approved, so we already have the chronic safety completed to the satisfaction of the FDA, we already have manufacturing supply chain completed to the satisfaction of the FDA, and you take all of things that are going on in this company, and we see that there's got to be a misconception somewhere," she added.
"Meet the Company" is The Fly's recurring series of exclusive short interviews with Executive Officers to offer a deeper look inside the company.