Phase 2

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We believe that by blocking GM-CSF signaling, mavrilimumab may be able to reverse the course of GCA by upstream targeting of the cell types driving the inflammatory process, a mechanism that is different from currently available therapies.

  • The GM-CSF signaling pathway has been shown to be upregulated in GCA biopsies versus control at both the messenger ribonucleic acid (mRNA) and protein level.
  • Mavrilimumab reduced inflammatory molecules characteristic of GCA pathophysiology in an ex vivo GCA artery culture model.
  • Mavrilimumab reduced arterial inflammation compared to control in an in vivo model of vasculitis.
  • In previous Phase 2b trials in rheumatoid arthritis, mavrilimumab demonstrated rapid and prolonged reductions in interleukin-6 (IL-6) production, which is indicative of suppression of tissue inflammation upstream.

Status: Phase 2

We are conducting a randomized, double-blind, placebo-controlled, global Phase 2 proof-of-concept clinical trial of mavrilimumab in patients with GCA.

The Phase 2 clinical trial is expected to enroll subjects with new-onset and refractory disease. Subjects will be randomized 3:2 to 150 mg of mavrilimumab or placebo injected subcutaneously once every 2 weeks and coadministered with a corticosteroid taper. Treatment duration is 26 weeks, and the primary efficacy endpoint is time to first flare. Topline data are expected in the second half of 2020.

Clinical Collaboration

We have a clinical collaboration with Kite, a Gilead Company, to conduct a Phase 2, multicenter study of mavrilimumab in combination with axicabtagene ciloleucel in relapsed or refractory large B-cell lymphoma. The objective of the study is to determine the effect of mavrilimumab on the safety of axicabtagene ciloleucel. Preclinical evidence shows the potential for interruption of GM-CSF signaling to disrupt chimeric antigen receptor T cell (CAR T)-mediated inflammation without disrupting anti-tumor efficacy. The Phase 2 trial is expected to commence in the second half of 2020.

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Unmet Need

Corticosteroids are the mainstay for the treatment of GCA, but approximately 50% to 70% of patients are corticosteroid refractory or corticosteroid dependent. Long-term administration of corticosteroids carries significant morbidity, especially in an elderly population such as in those with GCA. The FDA recently approved an inhibitor of IL-6 activity as an adjunct to a corticosteroid taper for the treatment of GCA; however, IL-6 production is downstream of GM-CSF and does not address all of the underlying causes of inflammation.

Explore Our Pipeline

We are intent on developing an array of innovative therapies that answer the many and varied needs of patients.