GlaxoSmithKline and Genmab have decided to refocus the development program for ofatumumab in autoimmune indications. GSK will focus development efforts on the subcutaneous delivery of ofatumumab in autoimmune indications and will stop further development on the intravenous administration in autoimmune disease.
Based on the positive results from the Phase I/II study in multiple sclerosis (MS), GSK plans to begin a Phase IIB dose ranging study in MS using the subcutaneous administration of the drug in 2011. Further work in rheumatoid arthritis (RA) with a subcutaneous administration of ofatumumab is under review.
"Although the IV delivery of ofatumumab has previously demonstrated positive results in MS and RA studies, the autoimmune program is being refocused on the subcutaneous delivery of ofatumumab because GSK believes this route of administration has the potential to offer added convenience and improved tolerability," said Ian Tomlinson, senior vice president, Biopharmaceuticals R&D, GSK.
Ofatumumab is currently not approved for any autoimmune indications. GSK and Genmab will continue their development of ofatumumab in multiple oncology indications with the intravenous route of administration.