Jaguar Health said an initial analysis of anti-diarrhoeal drug Mytesi (crofelemer) in cancer patients showed the Phase III trial did not meet its primary endpoint.
Shares in the Nasdaq-listed company opened 66% lower compared to a pre-announcement market close. Jaguar has a market cap of $12m.
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Already US Food and Drug Administration (FDA)-approved for the symptomatic relief of diarrhoea in patients with HIV/AIDS, Mytesi was being evaluated in adult cancer with solid tumours, some of whom were receiving chemotherapy.
Certain cancers can directly cause diarrhoea, whilst in some patients watery stools are brought on by chemotherapy drugs.
Jaguar stated that the Phase III OnTarget trial (NCT04538625) did not meet the prespecified analysis of primary endpoint for all tumour types, as measured by the frequency of the number of loose or watery stools.
Patients in the randomised trial either received 125mg of delayed-release Mytesi tablets or matching placebo tablets administered orally twice daily. The primary treatment phase lasted 12 weeks.
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By GlobalDataThough the data did not reach significance, Jaguar did say that analysis revealed “clinically relevant signs” in patients with breast and respiratory cancers. The additional 12-week extension phase is yet to be analysed; the company added. Jaguar stated it plans to engage with the FDA after it has fully reviewed the data.
Jaguar’s CEO Lisa Conte said: “We believe the OnTarget trial, designed boldly to address a broad array of cancer patients undergoing therapy known to be associated with diarrhoea, did not meet the primary endpoint given the heterogeneous nature of the patients enrolled in the trial.
“We will continue to review data from prespecified and non-prespecified OnTarget subgroups and then engage in discussions with the US Food and Drug Administration (FDA) to seek the most efficient pathway to bring crofelemer to these patients.”
Mytesi works by reducing the secretion of chloride ions from intestinal cells via inhibition of the cystic fibrosis transmembrane regulator (CFTR) chloride channel and the calcium-activated chloride channel (CaCC). This prevents high-volume water loss by stopping an osmotic pressure gradient forming in the intestines.
Following the Phase III setback, Conte said the US company is committed to going ahead with the clinical investigations for short bowel syndrome and microvillus inclusion disease – the latter being a very rare congenital diarrhoeal disorder. Jaguar has orphan drug designations from the FDA and the European Medicines Agency (EMA) for both indications. Proof-of-concept data is targeted for the end of 2024 and throughout 2025, Conte added.
