Phase II Clinical Failure AbbVie/Ironwood Decides to Abandon IBS Experimental Drug Development!

The latest top line data shows that The Second Stage clinical trial of MD-7246 to improve abdominal pain symptoms in patients with irritable bowel syndrome (IBS-D) did not reach the primary and critical secondary endpoints, and AbbVie and Ironwood Pharmaceuticals decided to suspend the development of this experimental non-opioid relieverIronwood's shares fell 12.4 percent as the news brokeMay 27, Ironwood released key data on randomized, double-blind, placebo-controlled 2 clinical NCT03931785, which was designed to assess the safety, tolerance, and therapeutic effect of abdominal pain symptoms in patients with IBD-7246A total of 388 adults with IBS-D-associated abdominal pain were recruited in the study, mD-7246 was divided into three dose groups (300 ?g, 600 ?g, 1200 ?g), and patients were randomly treated with MD-7246 or placebo once a dayThe main therapeutic endpoint was the change in the baseline of the most severe abdominal pain per week, and the overall abdominal pain response, defined as at least 6 weeks of abdominal pain at least 6 weeks, was reduced by at least 30% compared to the baselineresults showed that MD-7246 did not significantly improve IBS-D abdominal pain compared to placeboIn addition, MD-7246 is generally well tolerated and most adverse events are mild to moderate in severityThe most common adverse event is upper respiratory tract infection/nasopharyngitis, which occurs at a similar frequency as placeboabout 16 million people in the United States have IBS-DThese patients reported frequent abdominal pain (about 86 days a year on average), abdominal discomfort and bloating, accompanied by looser or more frequent bowel movements than usualMore than 80% of IBS-D patients surveyed reported moderate to severe symptomsthe drug MD-7246 is a slow release agent of Linaclotide, designed to release linalotide at the far end of the rectum near the return-blind jointAs a result, it has the potential to reduce abdominal pain and has limited effect on the intestinesLinalotide is a major brand of prescription drugs in the field of constipation therapy and has been approved in the United States to treat adults with irritable bowel syndrome with constipation (IBS-C) and chronic isopathic constipation (CIC)The drug was originally market-based by Ironwood and ElJian, which was renamed Linzess after ElJian was acquired by AbbViepreviously, MD-7246 was advanced to Phase 3 clinical studies of IBS-C treatment and performed wellIronwood noted that the results of a clinical trial of MD-7246 announced in December 2016 for double-blind, placebo-controlled, dose range 2b in adult patients with IBS-C pain showed that the drug improved abdominal pain and other abdominal symptoms (such as bloating and discomfort) numerically compared to placebo For abdominal pain, the percentage of baseline change in the MD-7246 group was -33.8% to -36.6% compared to the baseline at week 12, compared to the placebo group of -26.2% However, no significant effect on intestinal peristaltic function was shown these data support the assessment of the therapeutic role of MD-7246 in ibS-D populations In June 2019, Ironwood and Eljian again reported key data from Phase 3b clinical trials, demonstrating that MD-7246 improved overall bloating, bloating, and discomfort symptoms in adults with IBS-C, reaching all major and secondary endpoint indicators Even so, the two companies' decision to suspend the development of the MD-7246 may be related to a failure to excel in the drug, which could lead to poor market competitiveness Ironwood said AbbVie was reviewing the latest results to understand why MD-7246 had inconsistent efficacy in people with two different symptoms associated with IBS reference source: AbbVie, Ironwood abandon IBS drug MD-7246 after failed Phase II trial