New Analysis of MRI Findings Show UPLIZNA (inebilizumab-cdon) Reduced the Formation of Asymptomatic Optic Nerve Lesions in People With Neuromyelitis Optica Spectrum Disorder (NMOSD)

Horizon Therapeutics plc (Nasdaq: HZNP) today announced the presentation of new MRI imaging data from the Phase 3 clinical trial showing UPLIZNA reduced the formation of subclinical (asymptomatic) optic nerve lesions in people with NMOSD. These findings are being presented during the 49^th annual meeting of the North American Neuro-Ophthalmology Society (NANOS) March 11-16, 2023, in Orlando, Florida.

UPLIZNA is the first and only B-cell depleting monotherapy approved by the U.S. Food and Drug Administration, the European Commission and the Brazilian Health Regulatory Agency (ANVISA) for the treatment of NMOSD in adults who are anti-aquaporin-4 immunoglobulin G seropositive (AQP4-IgG+). The N-MOmentum pivotal trial (NCT02200770) is also the only Phase 3 clinical trial in NMOSD that collected MRI data and integrated MRI into its attack adjudication criteria. Results from the study demonstrated the significant effect of UPLIZNA in reducing the risk of NMOSD-associated attacks. This new post-hoc analysis based on MRI imaging provides a deeper understanding of the treatment effect on subclinical lesions.

“Data presented at the NANOS meeting show that gadolinium enhancement events of the optic nerve may occur in NMO patients without causing optic neuritis,” said Bruce Cree, M.D., Ph.D., MAS, study author and professor of clinical neurology at the University of California San Francisco Weill Institute for Neurosciences. “Although these subclinical optic nerve findings were smaller than those associated with optic neuritis attacks and were not predictive of future attacks, that the enhancement events occur shows there is a greater degree of complexity to attack pathogenesis in NMO than was previously appreciated. How these subclinical enhancement events contribute to the overall disease burden in NMO remains to be determined. Nevertheless, it is encouraging to see that repeated use of UPLIZNA decreased the rate of these subclinical optic nerve enhancements events over time.”

During the trial, MRI imaging was conducted on the spinal cord, optic nerve and brain/brainstem to quantify the frequency, prognosis and treatment response to UPLIZNA of subclinical lesions. This imaging was captured at the time of screening and at the end of the randomized controlled period (RCP), at the time of any attack and annually during the open label portion (OLP) of the trial.