Viela Bio, based in Gaithersburg, Md., announced that N-MOmentum, its Phase IIb pivotal trial of inebilizumab, met both primary and key secondary endpoints in neuromyelitis optica spectrum disorder (NMOSD).
Viela Bio, based in Gaithersburg, Md., announced that N-MOmentum, its Phase IIb pivotal trial of inebilizumab, met both primary and key secondary endpoints in neuromyelitis optica spectrum disorder (NMOSD).
Viela Bio was spun out of AstraZeneca’s MedImmune arm in February 2018 with six molecules from its early-stage inflammation and autoimmunity programs. Inebilizumab was the lead compound, which at the time was in Phase II development for neuromyelitis optica. The disease affects the optic nerve and spinal cord in about 5 in 1,00,000 people. The U.S. Food and Drug Administration (FDA) granted the drug Orphan Drug Designation in 2016 and the European Medicines Agency (EMA) gave it the same status in 2017.
Viela Bio launched with up to $250 million from a consortium of investors led by Boyu Capital, 6 Dimensions Capital, and Hillhouse Capital. AstraZeneca is the largest minority shareholder.
NMOSD is a recently proposed term used for neuromyelitis optica (NMO), which is also called Devic’s disease. It is a rare, severe, relapsing, neuroinflammatory autoimmune disease that can be fatal. About 80 percent of patients with NMOSD have autoantibodies to a water channel protein dubbed aquaporin-4 (AQP4). The AQP4-IgG autoantibodies bind primarily to astrocytes in the central nervous system, which can trigger attacks, leading to damage of the optic nerves, spinal cord and brain. This can lead to loss of vision, paralysis, loss of sensation, bladder and bowel dysfunction, nerve pain, and respiratory failure.
N-MOmentum enrolled 231 NMOSD patients, including patients with and without AGP4-IgG antibodies. They were randomized to receive two IV doses of inebilizumab monotherapy or placebo and followed for 6.5 months. They were then placed into an open-label extension where all patients received inebiluzumab for 6 months.
The primary endpoint of the trial was time from treatment initiation to occurrence of an NMOSD attack. Results showed a 77 percent decrease in the risk of developing NMOSD attack in patients receiving inebilizumab monotherapy compared to placebo. Secondary analysis showed a decrease in worsening of disability in patients receiving the drug.
Safety and tolerability were acceptable and consistent with previous data.
“These results support our hypothesis that CD19 expressing B cells including plasmablasts and plasma cells play a key role in the pathogenesis of NMOSD,” stated Jorn Drapa, Viela Bio’s chief medical officer and head of Research & Development. “This study demonstrated a highly significant and clinically meaningful reduction in attack risk and suggests a promising new treatment for patients diagnosed with NMOSD. We would like to thank the investigators, hospitals and most of all the patients who took part in this trial, without whom medical advancements would not be possible.”
Two of the company’s other portfolio drugs it brought from MedImmune include MEDI4920, now VIB4920, an anti-CD40L-Tn3 fusion protein to treat Sjögren’s syndrome, and MEDI7734, now VIB7734, to treat myositis. Sjögren’s syndrome is an immune system disorder noted for dry eyes and mouth that is often found along with other immune diseases, such as rheumatoid arthritis and lupus. Myositis is an inflammation of the muscles. Both are in Phase I trials. Three other programs are in preclinical or research stages.
