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Phase 2b trial initiated for two new formulations of Linzess
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A phase 2b trial of two oral colonic release formulations of Linzess for constipation-predominant irritable bowel syndrome has been initiated, the manufacturer announced.
The two formulations of Linzess (linaclotide, Allergan; Ironwood) are being evaluated together to potentially help advance both into late stage development: one indicated for IBS-C patients with abdominal pain and constipation, and the other for patients with other GI disorders and lower abdominal pain, according to a press release. These investigational formulations are designed to target delivery to the distal small intestine and colon with the aim of further reducing activity of pain-sensing colonic nerves with less fluid secretion.
“Abdominal pain is a key symptom of many gastrointestinal diseases, including IBS-C. Millions of patients are impacted by abdominal pain, and they have few prescription options,” David Nicholson, PhD, executive vice president of brand research and development at Allergan, said in the press release. “Our goal in this trial is to evaluate the potential of our two linaclotide colonic release formulations to provide enhanced abdominal pain relief to patients suffering from IBS-C as well as to evaluate the differences between the two formulations and inform a path forward for developing a drug that can reduce gastrointestinal pain in other disorders, such as other types of IBS, ulcerative colitis and diverticulitis.”
The investigators plan to enroll up to 520 adults with IBS-C in the current randomized, double-blind, placebo-controlled, multicenter trial, in which participants will be randomly assigned to receive placebo, linaclotide in its approved formulation, or one of various doses of the colonic release formulations, administered orally once daily for 12 weeks, according to the press release. IBS-C data are expected in the second half of 2016.
“With colonic release, we are seeking to peel apart the two components of the linaclotide mechanism of action, which we believe may lead to two product opportunities potentially addressing multiple unmet gastrointestinal needs,” Mark Currie, PhD, chief scientific officer and president of research and development at Ironwood, said in the press release. “The colonic release program is one of many efforts by Allergan and Ironwood to tap into linaclotide’s rich and pioneering pharmacology as we work together to address the broad spectrum of GI patients’ symptoms.”
Disclosures: Currie reports he is an employee of Ironwood. Nicholson reports he is an employee of Allergan.