Furiex Pharmaceuticals, a drug development collaboration company, has dosed its first patient in Phase 3 trials of MuDelta (JNJ-27018966) to treat diarrhoea-predominant irritable bowel syndrome (IBS-D).

MuDelta is an orally active, Phase 3 investigational agent with combined mu-opioid receptor agonist and delta-opioid receptor antagonist activity, which acts locally in the gut and has low oral bioavailability, deteriorating sedating side effects.

The dual-opioid activity is designed to treat diarrhoea and pain symptoms of IBS-D, avoiding the constipating side effects that can usually occur with mu-opioid agonists.

"MuDelta will fill an unmet need for an IBS-D treatment that has efficacy in both pain and diarrhoea, a good safety profile and a convenient dosing schedule."

Furiex president and chief medical officer, June Almenoff, said: "MuDelta is a first-in-class compound and we are extremely pleased that the Phase 3 trials have commenced and look forward to further advancing the development plan for this important therapeutic candidate."

The Phase 3 randomised, double-blind, placebo-controlled studies are designed to evaluate the efficacy, safety and tolerability of MuDelta in treating IBS-D.

The trials, one with a 52-week treatment period and one with a 30-week treatment period, are being conducted in the US, Canada and UK and are expected to enrol approximately 2,250 patients.

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Fred Eshelman, Furiex chairman, said the company believes that MuDelta will fill an unmet need for an IBS-D treatment that has efficacy in both pain and diarrhoea, a good safety profile and a convenient dosing schedule.

"It has the potential to create significant value as we progress its development," Eshelman added.

The company previously announced positive data from the Phase 2 MuDelta study, which achieved statistically and clinically significant results for its primary endpoints, as well as for a number of key secondary endpoints.

The Phase 2 study of MuDelta in patients with IBS-D, demonstrated durable efficacy through the 12-week treatment period.