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Ironwood Reports Positive Top-Line Results from Phase III Trial of 72 mcg Linaclotide in Adults with Chronic Idiopathic Constipation


Ironwood Pharmaceuticals, Inc. (IRWD) announced today that the Phase III clinical trial of its 72 mcg dose of linaclotide in adults with chronic idiopathic constipation (CIC) met the primary endpoint. Ironwood and partner Allergan plc intend to submit a supplemental new drug application to the U.S. Food and Drug Administration (FDA) in the first half of 2016.

Linaclotide is currently approved by the FDA as a 145 mcg capsule to be taken once per day for the treatment of adults with CIC and as a 290 mcg capsule to be taken once per day for the treatment of adults with irritable bowel syndrome with constipation (IBS-C).

Top-line data from the Phase III trial indicate that the 72 mcg dose of linaclotide demonstrated statistically significant improvement compared to placebo on the 12-week Complete Spontaneous Bowel Movements (CSBM) Overall Responder endpoint, the primary endpoint for the trial. Additionally, in a pre-specified sensitivity analysis, the 72 mcg dose of linaclotide demonstrated statistically significant improvement compared to placebo on the Durable CSBM Overall Responder endpoint, which is currently being requested by the FDA for Phase III CIC trials. Both the 72 mcg and 145 mcg linaclotide doses were generally well-tolerated in this trial. Consistent with previous Phase III trials of linaclotide, the most common adverse event reported in linaclotide-treated patients was diarrhea. The majority of diarrhea cases reported were characterized as mild in severity. The rates of diarrhea and of discontinuations due to diarrhea were lower for the 72 mcg dose than the 145 mcg dose in this trial.

“Linaclotide is the branded prescription market leader in the treatment of IBS-C and CIC, and we believe the availability of a 72 mcg dose could enhance its utility to physicians for use across the broad, heterogeneous CIC patient population, which encompasses some 35 million adult Americans,” said Tom McCourt, chief commercial officer at Ironwood. “With the successful completion of this trial, linaclotide has met all primary endpoints in all seven of its Phase III trials – spanning three doses and two indications. We are committed to continuing to innovate with this molecule, and we are developing multiple additional indications and formulations that, if approved, can address a broad spectrum of patient needs.”

The randomized, double-blind, placebo-controlled, multi-site Phase III clinical trial enrolled 1,223 adult patients with CIC. Patients with CIC were defined as having fewer than three spontaneous bowel movements per week, and they also may have experienced recurrent straining, lumpy or hard stools, and/or a sensation that they have not had a complete bowel movement. Patients were randomized to receive 72 mcg of linaclotide once per day, 145 mcg of linaclotide once per day, or placebo once per day for 12 weeks. A 12-week CSBM Overall Responder was defined as a patient who experienced at least three CSBMs per week and an increase of at least one CSBM from baseline in the same week (Weekly Responder), and achieved both of these measures for nine out of 12 weeks. A Durable 12-week CSBM Overall Responder comprises patients that were 12-week CSBM Overall Responders and also met the WeeklyResponder criteria for at least three of the last four weeks. The 145 mcg dose was included as a positive control and supported the validity of the trial for evaluation of the 72 mcg dose.

About Chronic Idiopathic Constipation

Chronic idiopathic constipation (CIC) is a functional...