AbbVie/Ironwood abandons IBS experimental drug development!

's latest top-line data show that phase 2 clinical trials to improve abdominal pain symptoms in patients with irritable bowel syndrome (IBS-D) did not reach the primary and critical secondary endpoints, and Abvers and Ironwood Pharmaceuticals decided to suspend development of the experimental non-opioid reliever. Ironwood's shares fell 12.4 percent on the news.On May 27, Ironwood released key data for randomized, double-blind, placebo-controlled Phase 2 clinical NCT03931785, which was designed to assess the safety, toerability and therapeutic effect of MD-7246 to improve abdominal pain symptoms in IBS-D patients. The study recruited a total of 388 adults with IBS-D-related abdominal pain, and MD-7246 was divided into three dose groups (300 μg, 600 μg, 1200 μg) and patients were randomly treated with MD-7246 or placebo once a day. The main therapeutic endpoints were the change in the weekly most severe abdominal pain compared to the baseline, and the overall abdominal pain response, defined as a reduction of at least 30% from the baseline for at least six weeks of 12 weeks.The results showed that MD-7246 did not significantly improve IBS-D abdominal pain compared to placebo. In addition, the MD-7246 is generally well-to-do, with mild to moderate severity of most adverse events. The most common adverse event is upper respiratory tract infection/nasopharyngitis, which occurs at a similar frequency to a placebo.In the United States, about 16 million people suffer from IBS-D. These patients reported frequent abdominal pain (an average of about 86 days a year), abdominal discomfort and bloating, accompanied by looser or more frequent stools than usual. More than 80% of IBS-D patients surveyed reported moderate to severe symptoms.The drug MD-7246 is a slow-release preparation for Linaclotide, which is designed to release linalotide at the far end of the reflect near the back-blind joint. As a result, it has the potential to relieve abdominal pain and has limited effects on the intestines. Rinalotide is a large brand of prescription drugs in constipation therapy and has been approved in the United States for the treatment of adults with irritable bowel syndrome accompanied by constipation (IBS-C) and chronic idiogenic constipation (CIC). The drug, which was originally market-owned by Ironwood and Aergean, was renamed Linzess after Aergean was acquired by AbbVie.Previously, MD-7246 advanced to phase 3 clinical studies of IBS-C therapy and performed well. Ironwood noted that the MD-7246, announced in December 2016, showed that the drug numerically improved abdominal pain and other abdominal symptoms such as bloating and discomfort compared to placebos in double-blind, placebo-controlled, dose-range Phase 2b clinical trials for adult patients with IBS-C. For abdominal pain, the percentage of baseline changes in the MD-7246 group was -33.8% to -36.6% compared to the baseline at week 12, compared to -26.2% in the placebo group. However, no significant effect on intestinal peristaltic function was shown.These data support the assessment of the therapeutic role of MD-7246 in the IBS-D population. 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 IBS-C adults and met all major and secondary endpoint targets. Even so, the two companies decided to suspend the development of the MD-7246, perhaps because the drug's advantages were not prominent and could lead to poor market competitiveness.Ironwood said AbbVie is reviewing the latest results to understand why MD-7246's efficacy is inconsistent among people with two different symptoms of IBS.
(Sina Pharmaceutical News)