Danish biotech firm Genmab A/S and Britain's GlaxoSmithKline announced the initiation of the phase III programme with Ofatumumab for the treatment of rheumatoid arthritis (RA).
The programme will begin with two studies (GEN410/OFA110635 and GEN411/OFA110634) outside the US, in two distinct patient populations. One study will be in patients who have had an inadequate response to methotrexate therapy and the other in patients who had an inadequate response to TNF-alpha antagonist therapy. Further studies to support the programme are planned for 2008, the companies informed.
Each study will evaluate the efficacy of ofatumumab in reducing the clinical signs and symptoms in RA patients after a single course of ofatumumab. It will demand a 24-week double-blind period followed by a 120 week open-label period during which re-treatment will be studied. The primary endpoint in each study is ACR20 at 24 weeks.
"This brings us closer to our goal of broadening the treatment options for patients with this painful and debilitating disease," said Lisa N. Drakeman, Ph.D., chief executive officer, Genmab. "From the data to date, we believe that ofatumumab has real potential. Now that phase III studies are underway in multiple indications, we are moving closer to realizing this potential and bringing this important treatment to patients."
"We are very pleased that our collaboration with Genmab has progressed so that we can now move to the next step of the clinical trial program," said Dr. Moncef Slaoui, chairman, Research and Development, GlaxoSmithKline.
Ofatumumab is an investigational, fully human, next generation monoclonal antibody that targets a unique epitope of the CD20 receptor on the surface of B-cells. This epitope is different than other anti-CD20 antibodies currently available or in development.
A total of approximately 250 patients who had an inadequate response to TNF-alpha antagonist therapy will be enrolled. In the double-blind period, patients will be randomised to receive two 700 mg doses of ofatumumab or placebo two weeks apart in addition to background methotrexate. Rescue treatment with nonbiologic disease modifying anti-rheumatic drugs (DMARDs) will be allowed from week 16 in the double-blind period. All patients who complete the double-blind period without rescue treatment will continue into the open-label period of the study. Re-treatment will be studied starting at week 24. Disease status will be measured every 4 weeks during the double-blind period and every 8 weeks during the open-label period.
Genmab is a leading international biotechnology company focused on developing fully human antibody therapeutics for unmet medical needs. Using unique, cutting-edge antibody technology, Genmab's world class discovery and development teams have created and developed an extensive pipeline of products for potential treatment of a variety of diseases including cancer and autoimmune disorders.
GlaxoSmithKline is one of the world's leading research-based pharmaceutical and healthcare companies and is committed to improving the quality of human life by enabling people to do more, feel better and live longer.