Celgene trial displays promising results for Crohn’s disease alternative treatment
pharmafile | October 17, 2016 | News story | Sales and Marketing | Celgene, Celgene corporation, Crohn’s disease, clinical trials, crohn's disease, phase I, trial
Celgene International, part of Celgene Corporation, has released the results from a Phase Ib trial showing improvement in patients suffering from Crohn’s disease.
The study examined the effects of oral GED-0301 (mongersen) 160 mg on both endoscopic response and clinical remission, with three different treatment regimens across a course of four, eight or 12 weeks. The most promising results occurred in the 12-week participation group, displaying a clinical response (CDAI decrease ≥100) and remission (CDAI <150) of 67% and 48% respectively. The results build on the back of positive prior results in a earlier trials.
Crohn’s disease is an immune-mediated, chronic inflammatory condition of the gastrointestinal tract. Estimated to affect as many as three out of every 1,000 people in Europe and North America, the disease is becoming more common for all ethnic groups. The symptoms of the disease include abdominal pain, diarrhoea, fatigue, fever, weight loss and malnutrition.
“We are encouraged that oral GED-0301 showed both meaningful endoscopic improvement and clinical remission at an early time point in this study,” said Scott Smith, President, Celgene Inflammation & Immunology. “The fact that this study included nearly 50 percent biologic-experienced patients further reflects the potential of GED-0301 as a novel approach for patients with Crohn’s disease searching for alternatives.”
The market for Crohn’s disease treatment is a highly competitive one. Leading drugs for treatment include AbbVie’s Humira and Janssen’s Remicade. However, not all patients respond to these treatment options, with roughly a quarter not responding to the anti-TNFs. There is therefore still potential for other pharmaceutical companies to acquire part of the market if they can offer a viable course of treatment for the patients who do not respond to these options.
Celegene will be hoping that the drug continues to build on its promise in trials. They had paid $710 million, in 2014, to buy the rights from Nogra Pharma.
Ben Hargreaves
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