Positive results for irritable bowel syndrome drug
pharmafile | September 14, 2010 | News story | Research and Development | Almirall, IBS, linaclotide
A new treatment for patients with irritable bowel syndrome with constipation has produced promising results in a phase III trial.
The drug, linaclotide, is being co-developed by Ironwood Pharmaceuticals with Forest (in the US) and Almirall (in Europe) and was shown to help relieve the symptoms of irritable bowel syndrome (IBS) and constipation.
“The results of this phase III trial, combined with previously reported positive linaclotide trial results, further support our belief that linaclotide has the potential to improve abdominal pain and bowel symptoms, offering a promising treatment for individuals suffering from this chronic gastrointestinal disorder,” said Peter Hecht, chief executive of Ironwood.
The two co-primary endpoints required by the European Medicines Agency (EMA) were met in this study, showing statistical significance and clinically relevant improvement for
linaclotide-treated patients both for abdominal pain/abdominal discomfort responder and IBS degree of relief responder over the three-month period.
Significant improvement was also seen for all pre-specified main secondary endpoints (stool frequency, stool consistency, straining, and bloating). The safety results were in-line with those observed in earlier linaclotide trials, with diarrhoea being the most common adverse event.
“IBS is a disease that severely impacts the quality of life of patients and linaclotide is a specific treatment developed for the relief of symptoms in this condition,” said Per Olof Andersson, Almirall’s executive director of R&D.
“These results are very promising and we believe linaclotide will be a valuable treatment in an area with such high unmet need. We look forward to the results of the second pivotal trial in Q4 2010 led by our partner Ironwood.”
Analysts at Jeffries International say the data is ‘consistent and compelling’ but they have issued a ‘conservative’ forecast of peak sales of $200 million in Europe.
Andrew McConaghie
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