Psoriasis Patients in Phase 1 Trial Receiving KY1005-CT01, a Potential Bowel Disease Therapy

Psoriasis Patients in Phase 1 Trial Receiving KY1005-CT01, a Potential Bowel Disease Therapy
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KY1005 clinical trial

A 24th psoriasis patient has received KY1005-CT01 in a Phase 1 clinical trial of the treatment designed to fight the autoimmune disorder affecting the skin and other organs.

KY1005 has the potential to treat several autoimmune disorders, including inflammatory bowel disease, or IBD. An autoimmune disease is one in which the immune system, whose job is to defend against invaders, attacks the body’s healthy cells instead.

The trial that Kymab is conducting includes healthy volunteers as well. The British company hopes to recruit 88 participants, and complete the study (NCT03161288) in 2018.

Kymab designed KY1005 to block the activation of OX40, a protein that lengthens T-cells’ immune response, which fosters autoimmune diseases. T-cells are a type of white blood cell.

KY1005, a human monoclonal antibody, brings the immune system back into balance, restoring the healthy organ function that the autoimmune disorder disrupted. One of its advantages is that it focuses specifically on autoimmune activity, in contrast with therapies that have broader effects, including undesirable ones.

The trial will evaluate the safety of KY1005, and participants’ ability to tolerate it. Researchers will test several doses. The patients in the study will have mild to moderate forms of psoriasis.

“I am delighted that we have reached another important milestone for Kymab,” Professor Allan Bradley,  Kymab’s chief medical officer, said in a press release. “Since our foundation [founding] only seven years ago, we have generated a number of best-in-class drug candidates using our exquisite antibody platform.” The company developed the platform “to contain the entire repertoire of human antibodies, making it the most comprehensive antibody development platform available.”

One study that Kymab arranged showed that KY1005 reduced the level of the immune response that causes acute graft versus host disease (GvHD), a frequent and potentially fatal complication of bone marrow transplants. Dr. Leslie Kean, associate director of the Ben Towne Center for Childhood Cancer Research at Seattle Children’s Research Institute, led that project.

A combination of KY1005 and a therapy that had failed to stop GvHD on its own prevented signs of the disease from developing. The results suggested that KY1005 can play an important role in treating immune diseases.

“KY1005 is the first of a series of products we are developing focused on autoimmune diseases, immune-oncology, hematology [blood diseases] and infectious disease,” said Dr. David Chiswell, Kymab’s CEO.

“This, the first of what will be a steady stream of clinical trials, is an important step towards realizing our vision,” he said. “Indeed, the potential of KY1005 is such that, on its own, it could treat a number of immune and inflammatory disorders. We are confident that this will be the first of several trials on this antibody alone.”

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