Celgene International Sàrl announced Sunday that their Phase 1 results showed that almost 60 percent participants entered remission after 12 weeks of using their oral GED-0301 160 mg. The results were significant in both endoscopic and clinical evaluations, giving hope to those suffering Crohn’s that do not respond to other treatments.
Celgene Corporation (Nasdaq: CELG) said Sunday that the data from a randomized, double-blind, multicenter, exploratory phase study evaluating GED-0301 is making patients bowls enter remission after week 12 of treatment.
Crohn’s disease is an immune-mediated, chronic inflammatory condition that affects the gastrointestinal tract. Symptoms include abdominal pain, diarrhea, weight loss, malnutrition, and fatigue. Crohn’s disease appears between the ages of 13 and 30, although it does not mean younger or older people can not suffer it.
The condition can affect any part of the gastrointestinal tract, including the mouth, but commonly, the most affected part is the small bowel, the ileum, and the beginning of the colon. Crohn’s disease affects three out of every 1,000 people in North America and Europe and unfortunately, is becoming more common in all ethnic groups. The exact cause of the disease is unknown, and there is no cure.
Luckily, Celgene’s pill for Crohn’s helped more patients than it was expected in Phase 1. Regarding patients experimenting improvement, 37 percent reported that GED-0301 made them feel better in a 25 percent or higher score.
To assess the effects of the pill, doctors used and endoscopic test to take pictures of the digestive tracts of 63 patients to evaluate whether the ulcers provoked by the disease were healing or not since taking the drug. On Sunday, 52 of the 63 patients had been studied and demonstrated that taking GED-0301 helps to heal the ulcers.
The more weeks the patient had been taking the drug, the better is their response to treatment. The group with the longest treatment length, which was 12 weeks, had the best outcomes. The announcement revealed that 48 percent of the participants enter remission.
Celgene’s pill works by promoting a protein in the gut to help control immune cells that attack the digestive tract when a person has Crohn’s disease. GED-0301 in its mid-stage trial showed that more than 60 percent of patients reported remission at the highest dose.
But there are some limitations to the partial results announced Sunday. The trial was based on part in what patients reported and not an examination of their bowels. The small portion that had endoscopic improvements is not significant yet. Celgene has not released the exact numbers of the whole study.
Crohn’s disease has no cure and the medicines available do not work on everybody
Johnson & Johnson’s Remicade and AbbVie Inc’s Humira have treatments available to help those suffering Crohn’s disease, but about a quarter of patients do not respond to those drugs, known as anti-TNFs.
Because of that gap, drugmakers such as Celgene, Biogen Inc., Gilead Sciences Inc., and Roche Holding AG are trying new approaches to finding a treatment to the quarter of patients with Crohn’s disease that do not respond to the existing therapies.
Celgene is more than committed to finding the perfect treatment for Crohn’s disease: the pharmaceutical company bought the rights to GED-0301 from Nogra Pharma Ltd., and paid $710 million upfront in 2014 for the formula.
People with the condition have lower life expectancy and often require surgery. Thus, Celgene’s efforts and their Phase 1 results are encouraging for the population suffering from Crohn’s disease that does not respond to other drugs.