November 19th, 2024
Hansoh Pharma Pharmaceutical Group Co., Ltd. (Hansoh Pharma, 03692.HK) today announced Inebilizumab has been granted Breakthrough Therapy Designation (BTD) by the US FDA following positive results from the Global Phase 3 MITIGATE study for the treatment of Immunoglobulin G4-related disease (IgG4-RD). New data from the MITIGATE study of Inebilizumab will be presented at American College of Rheumatology Convergence (ACR) 2024, in Washington, D.C, Nov. 14-19, 2024.
MITIGATE Study and its key findings in IgG4-related disease (IgG4-RD)
MITIGATE (NCT04540497) was conducted at 80 sites in 22 countries including China sites. It is the first randomized, double-blind, placebo-controlled study ever conducted in IgG4-RD, and establishes the safety and efficacy of CD19+ B cell depletion with inebilizumab in IgG4-RD.
Key findings include*:
·A clinically meaningful and statistically significant 87% reduction in the risk of IgG4-RD flare compared to placebo (Hazard Ratio 0.13, p<0.001) during the 52-week placebo-controlled period; seven of 68 participants receiving inebilizumab experienced a flare compared to 40 of 67 participants receiving placebo.
·A reduction in annualized flare rate for treated and adjudication committee-determined flares during the placebo-controlled period; 0.10 for participants receiving inebilizumab compared to 0.71 for participants receiving placebo (p<0.001).
·57.4% (39 of 68) of participants receiving inebilizumab achieved flare-free, treatment-free, complete remission at Week 52 compared to 22.4% (15 of 67) participants receiving placebo (p<0.001).
·58.8% (40 of 68) of participants receiving inebilizumab achieved flare-free, corticosteroid-free, complete remission at Week 52 compared to 22.4% (15 of 67) participants receiving placebo (p<0.001).
·Confirmation of the unique mechanism of action of inebilizumab to deliver rapid and sustained depletion of peripheral B cells leading to lowered levels of disease biomarkers. Flares are indicative of high disease activity.
Notably, 89.7% (61 of 68) of inebilizumab-treated patients required no glucocorticoid treatment for disease control during the placebo-controlled period, compared to 37.3% (25 of 67) of patients on placebo. After Week 8, inebilizumab-treated patients experienced a ten-fold reduction in total glucocorticoid use relative to placebo.
The safety results in the placebo-controlled period were consistent with the established safety profile of inebilizumab. The most common treatment-emergent adverse events included COVID-19, lymphopenia, urinary tract infection, and headache.
The data were simultaneously published in the New England Journal of Medicine. In August, the U.S. Food and Drug Administration granted Breakthrough Therapy Designation for inebilizumab in IgG4-RD based on data from the MITIGATE study, and regulatory filing activities are currently underway.
*All p-values follow the New England Journal of Medicine reporting guidelines; values smaller than 0.001 are presented as 0.001.
The trial was conducted with the support of Hansoh Pharma and the other partner. Hansoh Pharma is the exclusive licensee, local regulatory and commercial agent for China's mainland, Hong Kong, and Macau.
About Breakthrough Therapy Designation
The Breakthrough Therapy designation was enacted as part of the 2012 FDA Safety and Innovation Act (FDASIA) and is intended to expedite development and review of drugs to treat serious or life-threatening medical conditions when preliminary clinical evidence demonstrates that the drug may have substantial improvement on at least one clinically significant endpoint over available therapies. Breakthrough Therapy designation includes all the features of the Fast Track designation, as well as more intensive guidance from the FDA on a drug’s clinical development program.
About Immunoglobulin G4-related disease (IgG4-RD)
Immunoglobulin G4-related disease (IgG4-RD) is a chronic, systemic, immune-mediated, fibroinflammatory disease which can affect numerous and generally multiple organs of the body. It is a progressive disease affecting new organs over time either consecutively or simultaneously and is characterized by periods of remission and unpredictable disease flares. IgG4-RD can cause irreversible organ damage with or without the presence of symptoms. Awareness of how organ damage manifests is critically important to inform the timely diagnosis of IgG4-RD. B cells are central to the pathogenesis of IgG4-RD. In IgG4-RD, CD19-expressing (CD19+) B cells are thought to drive inflammatory and fibrotic processes and interact with other immune cells that contribute to disease activity.
The incidence is estimated at 1-5 in 100,000 although the number of IgG4-RD patients is difficult to determine based on limited epidemiology data. The typical age of onset of IgG4-RD is between 50 and 70 years old and, unlike many other immune-mediated diseases, IgG4-RD is more likely to occur in men than women.
About Inebilizumab (昕越®XINYUE)
Inebilizumab (marketed as 昕越®XINYUE in China) is a targeted CD19 B-cell depleting antibody for adult patients with NMOSD who are AQP4 antibody-positive developed by Viela Bio, Inc. (which was acquired by Horizon Therapeutics plc in March 2021, and Horizon Therapeutics plc was acquired by Amgen in December 2023). It was approved for marketing by the US FDA, the Ministry of Health, Labour and Welfare of Japan, and the European Commission in June 2020, March 2021 and April 2022, respectively.
On May 24, 2019, Hansoh Pharma obtained an exclusive license to develop and commercialize Inebilizumab in designated territories (i.e. the Chinese Mainland, Hong Kong and Macau regions).
