Twenty-four people have now received the multiple sclerosis and psoriasis therapy KY1005 in a Phase 1 clinical trial, according to its developer, Kymab.
The Cambridge, England, company creates human antibody drugs for autoimmune diseases. The trial will focus on KY1005 as a psoriasis therapy, although its mechanism of action should work in MS as well, Kymab said.
“KY1005 is the first of a series of products we are developing focused on autoimmune diseases, immune-oncology, hematology and infectious disease,” Dr. David Chiswell, Kymab’s CEO, said in a press release.
“Our vision is to build Kymab into a major global biopharmaceutical company,” he said. “This, the first of what will be a steady stream of clinical trials, is an important step towards realizing our vision. 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.”
KY1005 prevents a protein known as the OX40-Ligand from activating the protein it binds to, OX40. When activated, OX40 triggers the proliferation of memory and effector T lymphocytes, cells that regulate immune system responses.
OX40 plays a crucial role in the development of MS, studies in mice have shown. KY1005 blocks OX40L, allowing OX40 to rebalance the immune system and prevent autoimmune responses.
“I am delighted that we have reached another important milestone for Kymab,” said Professor Allan Bradley, a Kymab co-founder. Since the company’s founding “only seven years ago, we have generated a number of best-in-class drug candidates using our exquisite antibody platform,” he said. Kymab’s platform contains “the entire repertoire of human antibodies, making it the most comprehensive antibody development platform available.”
“To now have our first antibody firmly on its clinical [trial] development pathway, with a rich pipeline of future products following, is a significant milestone and a testament to the unique qualities of the antibody drugs produced by our proprietary antibody platform as well as the performance of the Kymab team in progressing them rapidly through development,” he said.
The Phase 1 trial (NCT03161288) will evaluate the effects of single and multiple ascending doses of KY1005 versus a placebo in healthy volunteers and people with a mild-to-moderate psoriasis, an autoimmune disease characterized by patches of abnormal skin.