Inebilizumab Neuroscolonshritis Spectrum Disorder Study Published in The Lancet

Haussen Pharmaceutical Partners, based in Gaithersburg, Md., is a clinical phase biopharmaceutical company sped up from MedImmune, the global bio-product research and development arm of British pharmaceutical giant AstraZeneca, focusing on innovative drug development in the field of inflammation and autoimmune diseases.

, Viela Bio announced that the results of a critical study to assess the treatment of optic neurospinal corditis spectrum disorder (NMOSD) N-MOmentum (NCT02200770) against CD19 monoantibilizumab (formerly KNOWN-551) have been published in the medical journal The Lancet. NMOSD is a rare, severe, relapsed, neuro-inflammatory autoimmune disease that can lead to severe muscle weakness and paralysis, vision loss, respiratory failure, and nerve pain.
At the end of August, the FDA accepted applications for biological product licensing (BLA) for the treatment of NMOSD. In the United States and the European Union, inebilizumab has been granted the qualification of orphan drugs for the treatment of NMOSD. In April, the FDA also granted inebilizumab a breakthrough drug (BTD) for the treatment of NMOSD.
N-MOmentum is the largest global, placebo-controlled study to date in the NMOSD field, with 231 patients in the group, including those with or without water channel protein-4 (AQP4)-IgG antibodies. In the study, patients were randomly divided into 2 groups and received 2 intravenous intra-drug therapy or placebos, followed for 6.5 months. After that, the patient enters the open label expansion period, and all patients receive inbilizumab treatment every 6 months. The main endpoint is from the beginning of treatment to the onset of NMOSD.
The results showed that after 28 weeks of treatment, in AQP4-IgG serologically positive patients, the risk of an NMOSD attack was significantly reduced by 77% (HR-0.227, p<0.0001) compared to placebo. In the total number of treated patients (including AQP4-IgG serologically negative patients), inebilizumab had a 73% lower risk of developing an NMOSD attack (HR-0.272, p<0.0001) compared to placebo. At the end of the random control period, 89% of AQP4-IgG serologically positive patients treated with inebilizumab had no seizures and 58% in the placebo group.
The study also reached a critical secondary endpoint: inebilizumab significantly reduced disability exacerbation compared to placebo (15.5% vs. 33.9%, p-0.0049), NMOSD-related hospitalization (10/10) 174 patients vs 8/56 patients, p=0.01), frequency of MRI damage to the newly developed central nervous system (79/174 patients vs 32/56 patients, p=0.0034). Another secondary endpoint of the study, vision, showed no statistically significant differences. In the study, inebilizumab had good safety and acceptable tolerance, and the rate of adverse events was similar to that of placebo. The rates of severe and/≥ 3 severe adverse events were similar, with 10.3 per cent in the inebilizumab treatment group and 14.3 per cent in the placebo group. At present, the open label extension of the study is in progress.
The mechanism of action of inebilizumab (MEDI-551) - Targeting CD19 depleted B cells NMOSD is a rare, destructive, supplement-mediated autoimmune disease of the central nervous system characterized by relapse, each recurrence leading to progressive accumulation of disabilities, including blindness and paralysis, and sometimes premature death. In NMOSD patients, about 80% of patients have autoantibodies to the water channel protein-4 (AQP4), which are thought to be produced by plasma and plasma cells and bind mainly to asbellatic glial cells in the central nervous system. The binding of AQP4-IgG antibodies to the central nervous system is thought to trigger attacks that damage the optic nerve, spinal cord and brain. Blindness, paralysis, sensory loss, bladder and intestinal dysfunction, nerve pain and respiratory failure can all be symptoms of the disease. Each NMOSD attack can result in further injury and disability. NMOSD is more common in women and may be more common in non-white people.
It's worth noting that at the end of June this year, soliris (eculizumab), the pioneering supplement inhibitor of rare disease giant Alexion, was approved by the U.S. FDA for use in adult patients with anti-water channel protein-4 (AQP4) antibody-positive optic neurospinal cord disease (NMOSD). Recently, Soliris was approved by the European Union for use in adult patients with AQP4 antibody-positive NMOSD with relapse. Soliris is the first and only approved drug to treat NMOSD in the United States and the European Union.
Inebilizumab is an anthogenetic monoclonal antibody with a high affinity with CD19, a protein widely expressed in B cells, including the production of antibodies in the pulp cells and some plasma cells. When inebilizumab binds to CD19, these cells quickly drain from the circulatory system.
At the end of May, Hansoh Pharma entered into a strategic partnership with Viela Bio to develop in-inebilizumab in China for the treatment of NMOSD and other potential inflammatory/autoimmune and hematological malignancies. Under the terms of the agreement, Viela Bio is eligible for an upfront partnership fee and milestone payments of more than $220 million, as well as tiered royalties based on net product sales. Howson Pharmaceuticals will be responsible for leading the development and commercialization of in-inebilizumab in China. (Bio Valley)
original source: Viela Bio Announces Publications in The Lancet of Pivotal Study Results of Inebilizumab in Patients with Neuromyelitis Spectrum