Horizon Therapeutics releases Phase 2/3 results for inebilizumab-cdon

Horizon Therapeutics has announced results of a retrospective analysis of the pivotal Phase 2/3 N-MOmentum clinical trial, indicating UPLIZNA may provide durable efficacy and a favorable safety profile for African Americans with NMOSD.

According to the company, UPLIZNA is the first and only FDA-approved anti-CD19 B-cell depleting humanized monoclonal antibody for the treatment of adult patients with anti-aquaporin-4 (AQP4) antibody positive NMOSD.

“Studies have shown that African Americans diagnosed with NMOSD often have a distinct experience managing this disease, including an earlier age of onset and more severe relapses compared with Caucasians, as well as different responses to targeted therapeutics,” Evanthia Bernitsas, MD, Department of Neurology at Wayne State University School of Medicine and lead study author, said in a statement. “This analysis provides useful information about how African Americans may benefit from UPLIZNA’s CD19 B-cell depleting mechanism to help reduce the incidence of acute attacks.”

According to Horizon, N-MOmentum consisted of a 28-week randomized controlled period (RCP), in which study participants received UPLIZNA or placebo, followed by an optional open-label period (OLP) during which all participants received UPLIZNA for at least two years.

The company noted that this analysis represents the experience of 20 African Americans who participated in the RCP (15 received UPLIZNA, five received placebo) and the OLP (20 received UPLIZNA).

Key analysis findings (P-045):

• Among African American participants who received UPLIZNA during the RCP and/or OLP, three of 19 had attacks 18, 29 and 104 days after their first UPLIZNA dose
  
• Annualized attack rate (AAR) for African Americans was 0.06 compared with 0.09 in the overall group with any UPLIZNA exposure
  
• Median AAR in the African American group in the two years before enrollment was 1.38
  
• In African American participants, UPLIZNA produced rapid and sustained B-cell depletion, consistent with other N-MOmentum trial participants
  
• During the RCP, African American participants in the UPLIZNA group developed fewer infections (26.7%) than those in the placebo group (60%), although one participant in the treatment arm developed cytopenia that resolved in four weeks

“NMOSD is a complex and often unpredictable disease that can be challenging to manage, especially in subpopulations that are disproportionally and more severely affected,” Quinn Dinh, MD, vice president, international medical affairs and pipeline launch strategy, Horizon, said in a statement. “Ongoing research with UPLIZNA can help inform treatment decisions in the clinic as physicians work to reduce the debilitating effects of this disease for their patients.”