A clinical trial that is investigating a drug designed to treat ulcerative colitis has completed patient enrolment, reports Business Wire.

Ulcerative colitis is a long-term inflammatory bowel condition. The severity of the symptoms varies between patients and over time, and for some people the condition can become debilitating. In ulcerative colitis the lining of the colon (bowel) develops small ulcers that release blood and pus. The condition is marked by symptoms such as frequent bouts of diarrhoea, often containing blood or pus, stomach pains, and frequent needs to empty your bowels. Other symptoms include fatigue, arthritis, and appetite and weight loss. Flare-ups of the condition can be associated with symptoms such as an irregular or fast heartbeat, a fever, and shortness of breath. The cause of flare-ups is usually unknown, although they have been suggested to be linked to stress and gut infections. Almost 1 million people living in the US are thought to be affected by the condition. Treatment usually aims to reduce the severity of the symptoms through preventing and treating flare-ups. Many patients take medications, and some may need surgery.

The company behind the on-going clinical trial, Abivax, aims to develop treatments for ulcerative colitis, other autoimmune diseases, and cancer, through using the immune system as a way to cure them. The drug being tested is called ABX464 and is being given to patients in 50mg doses once per day for two months. Thirty patients are taking part in the study throughout seventeen centres in seven European countries. All patients have moderate-to-severe ulcerative colitis and have unsuccessfully tried certain other medications. Two thirds will be given the drug while the other third receives a placebo. The study will use a placebo and a randomised double-blind framework, where neither the medical professionals administering the drug nor the patients know whether they are using a trial drug or the placebo. The study will evaluate the effectiveness and safety of the experimental medicine using cutting edge monitoring technologies.

The study itself is based on pre-clinical data that showed the drug, ABX464, acts as an anti-inflammatory. It functions by causing a 50x increase in the expression of a molecule called IL-22 that prevents the inflammatory process. The drug also leads to a 10x increase in an RNA molecule known to have anti-inflammatory effects. By reducing inflammation, it is hoped that the symptoms of ulcerative colitis can be alleviated.

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