Clinical Trials

Date: 2011-10-24

Type of information: Results

phase: 3

Announcement: results

Company: Almirall (Spain)

Product: linaclotide

Action mechanism:

• peptide. Linaclotide, a first-in-class investigational drug, is an agonist of the guanylate cyclase type-C (GC-C) receptor located on the luminal surface of the intestine. In preclinical models, linaclotide reduced visceral hypersensitivity, increased fluid secretion, and accelerated intestinal transit. The effects on secretion and transit are mediated through cyclic guanosine monophosphate (cGMP), which is also believed to modulate the activity of local nerves to reduce pain. Linaclotide is an orally delivered peptide that acts locally in the gut with no measurable systemic exposure at therapeutic doses and is intended for once-daily administration.

Disease: irritable bowel syndrome with constipation (IBS-C)

Therapeutic area: Digestive diseases - Gastrointestinal diseases - Inflammatory diseases

Country:

Trial details:

Latest news: Almirall has announced that full results from two pivotal Phase III clinical trials assessing the efficacy and safety of once-daily dosing of linaclotide 290 mcg in patients with IBS-C are presented at the 19th European Gastroenterology Week (UEGW) congress showing that linaclotide significantly improved abdominal pain/discomfort and relieved IBS-C symptoms. The impact of linaclotide on patients’ quality of life from baseline to 12 weeks was measured using the Irritable Bowel Syndrome – Quality of Life Questionnaire (IBS-QoL). Pooled data from the two Phase III trials show that linaclotide statistically significantly improved IBS-QoL overall scores and seven out of eight important QoL domains (dysphoria, body image, health worry, sexual relationships, food avoidance and social reaction) compared with placebo in adults with IBS-C (p<0.001). The data also demonstrate that the proportion of patients meeting responder criteria for a ?10-point or ?14-point change from baseline was statistically significantly greater for patients treated with linaclotide versus placebo at week 12 for the IBS-QoL overall and all eight subscale scores (p<0.05).

Is general: Yes