After having completed a Phase III registrational trial investigating its treatment for diarrhoea related to cancer care called Mytesi (crofelemer), Jaguar Health is planning for a readout before the end of 1H, said the company’s CEO, Lisa Conte.
In an exclusive interview with Pharmaceutical Technology, Conte shared the company’s plans to develop human and animal pharmaceuticals, discussing the company’s operations across the two areas of drug development.
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By GlobalDataUpon analysis of the Phase III readout for Mytesi, the company will consider options such as a major corporate partnership, and a potential financing round, and likely file a supplemental new drug application before the end of 2024. Following that, Conte forecasts an approval decision in the next six to nine months. After working with and speaking to patient advocacy groups, she expected several groups would rally for the therapy’s approval in the US.
The US Food and Drug Administration (FDA) approved Mytesi as the first treatment for noninfectious diarrhoea in adults who are living with HIV and on antiretroviral therapy (ART). Jaguar acquired the therapy from Napo Pharmaceuticals in a definitive merger agreement signed in March 2017. Crofelemer acts as a cystic fibrosis transmembrane conductance regulator blocker, normalising the function of the gastrointestinal tract.
Marketed as Canalevia for animal use, Jaguar received a conditional FDA approval for crofelemer, making it the first oral tablet to treat chemotherapy-induced diarrhoea in dogs in December 2021. On 15 February, the company declared that it had received an FDA approval for its clinical protocol for a field study assessing the therapy in the same indication, which would help it attain a full approval. “As long as we complete the field study before 2026, our conditional approval will become a full approval,” said Conte.
Conte explained that the company first discovered the drug’s full potential for dogs in preclinical studies ahead of its human clinical trials. “The site at which crofelemer works in normalising gut function is highly conserved between humans and dogs… So, as we were going through the development process in humans, we thought why not look at what the opportunity would be to get this approved in dogs,” she added. Following the success of Canalevia, the company aims to continue developing its animal pharmaceutical development alongside its human pipeline.
Despite the shaky pharmaceutical investment environment of the last few years, investment into its younger Jaguar Animal Health Subsidiary has not been a major issue, said Conte. She added, “Because dogs have a shorter lifespan than humans, you get faster answers about the benefits of treatments…I was a bit surprised by how much the investor community embraces the fact that we are in animal health as well as well.”
Update: The first paragraph has been updated to reflect the correct timeline for the Phase III Mytesi readout. A previous version said results were expected in H2 owing to the CEO misspeaking during the interview.
