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Genmab, GSK to start studies of subcutaneous ofatumumab for RRMS and NMO

Denmark-based Genmab has announced that its collaboration partner GlaxoSmithKline (GSK) has taken the decision to start additional pivotal studies with the subcutaneous formulation of ofatumumab.

The Phase III trials of subcutaneous ofatumumab in relapsing-remitting multiple sclerosis (RRMS) are expected to start in 2015, following encouraging data from a Phase II trial reported in October 2013.

Additionally, GSK intends to submit an Investigational New Drug (IND) application in 2014 for a potential pivotal study of subcutaneous ofatumumab in neuromyelitis optica (NMO), a rare autoimmune disorder which affects the optic nerve and spinal cord.

In 2013, the company had announced a Phase III trial of subcutaneous ofatumumab in pemphigus vulgaris, a rare autoimmune disorder of the skin.

Genmab chief executive officer Jan van de Winkel said, "We saw promising data in Phase II in relapsing-remitting multiple sclerosis at the end of 2013 so we are very pleased that development of subcutaneous ofatumumab will continue in this autoimmune disorder and look forward to further development in NMO."