New Drug for Autoimmune Diseases Shown to Be Safe

A new treatment for autoimmune diseases was found to have a clear modulatory effect on the immune system and also be safe, with no adverse side effects. Data demonstrated that there was an increase in the regulatory cells controlling the immune response in the body. Moreover, there was a decrease in the cytokines that induce inflammation.

Hadasit (Jerusalem, Israel), the technology transfer company of Hadassah Medical Organization in Jerusalem, Israel, and Brigham and Women's Hospital (BWH; Boston, MA, USA), a teaching affiliate of Harvard Medical School (Boston, MA, USA), announced the successful results of a phase I study of a new orally administered drug for immune mediated diseases such as diabetes, Crohn's disease, psoriasis, multiple sclerosis, and liver diseases. The trial was announced in January 2008.

The results enabled the clinical team to identify the mechanism of the effects as well as to determine which cells in the immune system are involved in the process of defense. "Any time you go from preclinical to clinical you never know what you are going to see. First, to our pleasant surprise, we were able to modulate the immune system in exactly the way we wanted. Secondly, the fact that we observed the same results in the phase I clinical study as those in the animal studies is very exciting. We know that the new drug works in animals, so, based on our findings in healthy patients, we now have the confidence to test the drug in humans with disease. Finally, when a monoclonal antibody is administered intravenously, which is the way they are given in medicine, the body has been known to rebel by building immunity to it. This was not the case with the orally administered drug,” said Dr. Howard L. Weiner, a professor of neurology at Harvard Medical School, director of the Partners Multiple Sclerosis Center at Brigham and Women's Hospital and a pioneer in the fields of oral tolerance and oral administration of the monoclonal antibody.

The phase I trial, which included 18 healthy male participants, in their 20s and 30s, investigated dosing, safety, and the immunologic effects of the drug, which was given orally, once daily, for a week. The study was conducted at the Hadassah Hospital, Jerusalem, Israel. The drug is based on monoclonal antibody (anti-CD3) and a glycolipid given separately and together.

"This was one of the most complicated studies ever performed on human beings to show that immune modulatory effects can be achieved based on the concept of oral tolerance and oral dosing. We now have a proof of concept that the therapy is safe in humans and that it can affect the immune system,” said Dr. Rafi Hofstein, CEO of Hadasit.

Phase II studies are anticipated to begin during the second half of 2008. Indications under consideration include multiple sclerosis, hepatitis C, diabetes type II, and fatty liver disease.


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