BEACON TRANSCRIPT – Celgene revealed optimistic results in relation to its Crohn’s Disease drug as early stage trials mark a clinical improvement, low remission rates.
Celgene International Sarl is currently in the middle of a smaller scale trial test that is to determine the efficiency of its GED-0301 (mongersen) drug in the treatment of Cohn’s disease.
Crohn’s disease is an inflammatory bowel disease (IBD) that affects the gastrointestinal tract. Its symptoms usually include abdominal pain, fever, weight loss, and bloody diarrhea in severe cases. Left untreated, it can lead to further complications such as skin rashes, anemia, arthritis, or even worse.
Celgene’s latest drug trial results, which were released Sunday but will be officially presented at the United European Gastroenterology Week, showed a 37 percent improvement rate in the case of ulcer healing, with an over 25 percent increase in the patients’ healing rate after a 12 weeks period.
The company maintained an optimistic position in regards to the early trial results, although most Crohn treating doctors consider a minimum 50 percent improvement rate as needed before calling an endoscopic response a treatment.
The trial phase involved a number of 63 patients suffering from moderate to severe form of the disease. The patients were split into 3 random groups and were given over a 12 weeks period a mix of the GED-0301 drug with, or without, placebos depending on the group.
One group received a daily dose of 160 mg single administration of GED-0301 for all the 12 weeks. Another group received one daily dose of 160 mg of GED-0301 for 8 weeks and placebo drugs for the remaining 4. The last group received a four weeks worth of the one daily dosage of GED-0301 of 160 mg, and placebo drugs for the remaining eight weeks period.
A clinical improvement was observed throughout all the groups, with the highest rates of response being registered in the second and last weeks of treatment. All groups marked an endoscopic improvement in the twelfth week.
The adverse events, from the low to the severe scale, were similar and low throughout all the treatment groups, with no safety precautions being needed in the case of the GED-0301 oral 160 mg daily dose administration.
This marks the Phase III of the Crohn’s disease drug trial, with patients being held under observation until 2017, when data results from the observation phase are to be expected.
With an estimated 3 out of 1,000 people across North America and Europe being affected by Crohn’s disease, Celgene could come with a new drug that would place it amongst the already existing and approved medicines that help treat and cure the disease.
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