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.
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.
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.