Bristol Myers Squibb Announces Orencia (Abatacept) Improved Survival in Hospitalized Adults with Moderate to Severe COVID-19 in Phase 3 ACTIV-1 Trial

News on June 8, 2022 /BioValleyBIOON/ Recently, Bristol-Myers Squibb (BMS) announced the Phase 3 ACTIV-1ImmunityTop-line Results of the Modulator Clinical Trial. The trial, sponsored by the National Institutes of Health (NIH), evaluated the administration of a single dose of immunomodulator — including Orencia (Chinese trade name: Enrui Shu) — in addition to standard care.^®, Generic name: abatacept, (brand name: Orencia), efficacy and safety compared to placebo,The purpose is to determine whether modulating the immune system response can accelerate moderate to severeCOVID-19Rehabilitation and Reduction of Casualties in Hospitalized Adult Patients.

The results showed,Compared with placebo, Orencia treatment showed significant improvement in the primary endpoint of recovery time measured by discharge days, but inStatisticsNot statistically significant. The analysis of secondary endpoints (including mortality and clinical conditions) showed,Compared with placebo, Orencia treatment reduced the risk of death in patients and improved their clinical condition 28 days after entering the study.Patients treated with Orencia had a lower risk of death, with a mortality rate of 11%, compared to 15% for patients treated with placebo,Orencia Treatment Group Shows 37.4% Lower Mortality Risk Compared to Placebo GroupIn patients with moderate and severe diseases, the relative improvement in mortality was similar.Patients in the Orencia treatment group were 34.2% more likely to experience clinical improvement than those in the placebo group.The safety profile of Orencia remains consistent, with no new safety signals reported in the study.

The full results of the study will be published in a peer-reviewed journal. Based on the positive findings from the topline results, Bristol-Myers Squibb plans to collaborate with the U.S. Food and Drug Administration.ManagementBureau (FDA) Discuss these data and possible measures that may be taken in the future.

Bristol-Myers Squibb Chief Medical Officer Samit Hirawat, M.D., said: "As treatments continue to be needed around the world to address the threat of COVID-19, we are proud to participate in the ACTIV-1 Immune Modulators clinical trial and related scientific research associated with the virus. The devastating resurgence associated with prevailing and emerging COVID variants underscores the need for additional treatment options for hospitalized patients. We are pleased to have data showing a lower risk of death in patients treated with Orencia and look forward to continuing to work with the NIH to evaluate the data and potentially make this treatment option available to patients in need."

Orencia is a selective T-cell co-stimulation immunomodulator., Orencia is a soluble fusion protein produced through recombinant DNA technology, consisting of the extracellular domain of human cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) linked to a modified human immunoglobulin G1 (IgG1) Fc portion (hinge, CH2, and CH3 domains). Orencia binds to CD80 and CD86 ligands on antigen-presenting cells via the extracellular domain of CTLA-4, thereby blocking their interaction with CD28 on T-cells and inhibiting T-cell activation. Activated T-cells are thought to be associated with various inflammatory diseases, includingRheumatoid Arthritis(RA), psoriatic arthritis (PsA), juvenile idiopathic arthritis (JIA), etc. Full activation of T-cells requires at least two signals from antigen-presenting cells, where the interaction between CD28 on T-cells and CD80 or CD86 on antigen-presenting cells is a key step in co-stimulatory signal transduction.

Mechanism of Action of Orencia

Orencia is an immunomodulator designed to interrupt the continuous cycle of T-cell activation.. In the United States, Orencia has been approved for four indications: (1) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). (2) for the treatment of patients aged 2 years and older with moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA). (3) for the treatment of adult patients with active psoriatic arthritis (PsA). Regarding medication, it is not recommended to use Orencia simultaneously with other potent immunosuppressants, such as: biologic disease-modifying antirheumatic drugs (bDMARDs), JAK inhibitors. (4) for patients aged 2 years and older undergoing unrelated donor hematopoieticStem CellsTransplant (URD-HSCT) in adult and pediatric patients,PreventionAcute Graft-Versus-Host Disease (aGVHD). Notably, Orencia is the first drug approved by the U.S. FDA for the prevention of aGVHD.

In mainland China,Orencia (Chinese brand name: Enrui Shu)^®, Generic Name: Abatacept Injection)Developed in collaboration by Simcere Pharmaceutical and Bristol-Myers Squibb (BMS). On August 9, 2020, Orencia (Enrui Shu^®) successfully held its launch conference, which also marks the official entry of this product into the commercial distribution phase in mainland China. As the first and only T-cell selective co-stimulation immune modulator approved in the global rheumatoid arthritis field, the full-scale launch of Enrui Shu® in mainland China is benefiting the 6 million rheumatoid arthritis patients in China, a number that is increasing annually. (Bioon.com)

Source of the original text:Bristol Myers Squibb Announces Topline Results Showing Treatment with Orencia (abatacept) Improved Survival in People Hospitalized with COVID-19