Morphosys receives milestone as GSK advances RA antibody – German biotech MorphoSys (NASDAQ: MOR), a holding of International Biotechnology Trust (IBT), has received a €22m milestone payment from its licensing partner GlaxoSmithKline (GSK) in connection with the start of a Phase III trial programme with otilimab (formerly MOR103/GSK3196165) in rheumatoid arthritis (RA).
GSK will conduct four studies:
- contRAst-1 (201790): Compares the efficacy and safety of otilimab with placebo and with tofacitinib (Pfizer’s Xeljanz, an oral JAK inhibtior), all in combination with methotrexate (MTX), over 52-weeks in approximately 1500 -1700 patients with moderately to severely active RA who have an inadequate response to MTX.
- contRAst-2 (201791): Compares the efficacy and safety of otilimab with placebo and with tofacitinib, all in combination with conventional synthetic DMARDs, over 52-weeks in approximately 1500-1800 patients with moderately to severely active RA who have an inadequate response to conventional synthetic DMARDs or biologic DMARDs.
- contRAst-3 (202018): Compares the efficacy and safety of otilimab with placebo and with sarilumab (sanofi/regeneron’s Kevzara), all in combination with conventional synthetic DMARDs, over 24-weeks in approximately 500-600 patients with moderately to severely active RA who have an inadequate response to biological DMARDs and/or JAK inhibitors.
- contRAst-X (209564): Patients who complete the pivotal studies may be eligible to participate in a long-term extension study to further evaluate the efficacy and safety of otilimab for up to 4 years.
Otilimab is a fully human antibody directed against the granulocyte-macrophage colony-stimulating factor (GM-CSF). MorphoSys licensed it to GSK in June 2013.