Furiex Pharmaceuticals Announces First Patient Dosed in Phase III Clinical Trials of MuDelta in Diarrhea-Predominant Irritable Bowel Syndrome
Business WirePress Release: Furiex Pharmaceuticals – Tue, Jun 19, 2012 4:06 PM EDT
MORRISVILLE, N.C.--(BUSINESS WIRE)--
Furiex Pharmaceuticals, Inc. (FURX) today announced dosing of the first patient in its Phase III randomized, double-blind, placebo-controlled studies evaluating efficacy, safety and tolerability of MuDelta (JNJ-27018966) in the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D). Furiex is conducting two simultaneous Phase III trials, one with a 52-week treatment period and one with a 30-week treatment period, in study centers in the United States, Canada and United Kingdom. Combined, the trials are expected to enroll approximately 2,250 patients.
Furiex previously announced the successful completion and outcome of its Phase II study to assess the safety and efficacy of an oral formulation of MuDelta in patients with IBS-D. The study achieved statistically and clinically significant results for its primary as well as a number of key secondary endpoints, and demonstrated durable efficacy through the 12-week treatment period.
“MuDelta is a first-in-class compound and we are extremely pleased that the Phase III trials have commenced and look forward to further advancing the development plan for this important therapeutic candidate,” said June Almenoff, M.D., Ph.D., president and chief medical officer of Furiex.
Added Fred Eshelman, Pharm.D., chairman of Furiex, “We believe MuDelta will fill an unmet need for an IBS-D treatment that has efficacy in both pain and diarrhea, a good safety profile and a convenient dosing schedule. It has the potential to create significant value as we progress its development.”
In November 2011, we acquired full exclusive license rights to develop and commercialize MuDelta under our existing development and license agreement with Janssen Pharmaceutica, N.V., or Janssen. Under the terms of our agreement Janssen will be eligible to receive a $5 million milestone payment upon dosing of the fifth patient in the Phase III trial, up to $45 million in regulatory milestone payments and, if approved for marketing, up to $75 million in sales-based milestone payments and sales-based royalties increasing from the mid to upper single digit percentages as sales volume increases. Royalties are to be paid for a period of ten years after the first commercial sale or, if later, the expiration of the last valid patent claim or the expiration of patent exclusivity.
For more details about these trials, please visit www.clinicaltrials.gov.
About MuDelta
MuDelta is a novel, orally active, Phase III investigational agent with combined mu opioid receptor agonist and delta opioid receptor antagonist activity which acts locally in the gut and has very low oral bioavailability, diminishing sedating side effects. This dual opioid activity is designed to treat diarrhea and pain symptoms of IBS-D, without causing the constipating side effects that can occur with mu opioid agonists.
About IBS-D
Diarrhea-predominant irritable bowel syndrome is a functional bowel disorder characterized by chronic abdominal pain and frequent diarrhea, which affects approximately 12 million Americans. Although the exact cause of IBS-D is not known, symptoms are thought to result from a disturbance in the way the gut and nervous system interact. IBS-D can be extremely debilitating and there are limited therapeutic options for managing the chronic symptoms. IBS-D is associated with economic burden in direct medical costs and indirect social costs such as absenteeism and lost productivity, along with decreased quality of life.
