Jaguar Health has announced data from a prespecified subgroup in the previously failed Phase III oncology trial, which showed it benefitted patients with breast cancer. Image credit: Shuterstock / Spyro the Dragon.

A diarrhoea drug by Jaguar Health that previously failed in a Phase III oncology trial has shown statistically significant benefit in a prespecified subgroup of breast cancer patients.

In July 2024, Jaguar announced the Phase III OnTarget trial (NCT04538625), conducted by Jaguar family company Napo Pharmaceuticals, evaluating crofelemer failed to meet the primary endpoint of frequency of diarrhoea across all tumour types. At the time, the company said the drug did reveal clinically relevant signals in prespecified subgroups that comprise patients with breast and respiratory cancer, including lung cancer.

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After the July announcement, shares in the Nasdaq-listed company opened 66% lower compared to a pre-announcement market close.

In an announcement yesterday (1 October), Jaguar revealed a prespecified subgroup of adult patients with breast cancer dosed with crofelemer achieved statistical significance in the primary endpoint. Jaguar said the drug has the potential to help breast cancer patients to better adhere to their cancer therapies.

Despite the positive update, the company’s share price opened slightly lower on 1 October ($1.29) compared with the 30 September close ($1.35).

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Patients receiving chemotherapy, immunotherapy or targeted drug therapy can suffer from diarrhoea as an adverse event of treatment. There are some approved therapies, including Immodium (loperamide) used to treat diarrhoea, as well as IV fluids to rehydrate patients.

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Jaguar’s president and CEO Lisa Conte said: “This data in breast cancer patients has been submitted to a relevant oncology conference by the study’s primary investigators, and a full study report for the breast cancer results is expected to be submitted to a peer-reviewed journal. Additional analyses of OnTarget prespecified subgroups are ongoing, and we believe data from additional analyses may result in future submissions to peer-reviewed forums.”

Patients with breast cancer accounted for nearly 180 of the 287 participants in the clinical trial to treat diarrhoea in adult patients with solid tumours receiving targeted therapy with or without standard chemotherapy.

Crofelemer was approved by the US Food and Drug Administration (FDA) for symptomatic relief of non-infectious diarrhoea in adults with HIV/AIDS on antiretroviral therapy in December 2012. It is marketed as Fulyzaq or Mytesi for this indication.

The drug has also demonstrated clinically meaningful benefits in patients with diarrhoea-predominant irritable bowel syndrome (IBS-D), specifically functional and chronic idiopathic diarrhoea.

Conte added that the IBS-D data will be presented at the American College of Gastroenterology Annual Scientific Meeting, taking place from 25 to 30 October in Philadelphia.