Rheumatoid arthritis (RA) first antibody drug coupling (ADC)! Abbvie ABBV-3373 Proof of Concept II study successfully!

JUNE 11, 2020 /PRNewswire/ -- AbbVie has released new data from abbV-3373 for the treatment of moderate to severe rheumatoid arthritis (RA) adult patients (M16-560)ABBV-3373 is a new antibody conjugate (ADC) consisting of anti-tumor necrosis factor antibody adamum monotodeficiency (adalimumab) and glucocorticoid receptor regulator (GRM)AbbV-3373 effectively reduces disease activity and shows no systematic glucocorticoid effect, according to new data released this timeIt's worth noting that this is the first report on the results of a new Type OfDA in RA treatmentThe full results of the IIa study will be presented at the upcoming medical conference and will be published in a peer-reviewed journalABBV-3373 is a research ADC developed by AbbVie, which is connected to adalimumab by a new type of glucocorticoid receptor regulator (GRM) to regulate tNF-mediated inflammatory pathways by delivering a glucocorticoid payload directly to activated immune cells of the expression membrane-binding tumor necrosis (TNF)This ADC is designed to accurately target activated immune cells while significantly suppressing inflammation and reducing systemic side effects associated with glucocorticoidsABBV-3373 is an unapproved research drug that is currently being studied for the treatment of rheumatoid arthritis (RA) and other immune-mediated diseasesThe RA-Rheumatoid Arthritis (Photo: rheumatologyadvisor.com) M16-560 study is a 2a-phase, multi-center, randomized, double-blind, double-simulated, positive drug-control study in adult patients with moderate to severe rheumatoid arthritis (RA) who responded insufficiently to assess the safety, resistance, resistance, and efficacy of ABBVV-3373In the study, patients were randomly assigned at 2:1, received ABBV-3373 (n-31, dose 100 mg, every other weekly .EOW) or Adamu monotoidatis (n-17, dose 80 mg, EOW), and treated for 12 weeksIn this proof-of-concept study, sufficient statistical capacity was obtained using Bayesian statistical methods containing historical data, which were performed by pre-specified supplementing the Adamu monobiton data in the experiment using Adamu mono-resistance historical data, and compared with ABBV-3373 for major endpoint analysisThe historical data were obtained from three Adaliwood monotodrine trials similar to the therapeutic environmentThe main endpoint was a change in the disease activity score of 28 C-reactive protein (DAS28-CRP) from the baseline check to week 12, with two statistical comparisons pre-specifiedThe first item compared the average results of ABBV-3373 and historical Adamu mono-resistance data, and the success criterion was a two-sided p-value of 0.1The second item compares ABBV-3373 with the combined experimental and historical Adamu monobiton data (success criteria: probability - 95%)The results of the first statistical comparison show that the difference between the ABBV-3373 treatment group from the baseline to the main endpoint of week 12, DAS28-CRP, was greater than the pre-specified historical Adamu mono-anti-average (-2.13)The results of a second statistical comparison based on Bayesian analysis showed that ABBV-3373 had a 90% probability of greater improvement associated with the baseline to week 12 DAS28-CRP compared to The Aadamita, which combined experimental data and historical data In addition, an assessment of serum cortisol levels during the 12-week period of treatment showed no systematic glucocorticoid effect in ABBV-3373 In the experiment, the safety of the ABBV-3373 was similar to that of Adamu monoto-resistance The overall adverse event (AE) incidence of ABBV-3373 is lower than that of Adamu monobify (35% (n?11) vs 71% (n?12) respectively) AE occurred in the patients with urinary tract infection, ABBV-3373 had 2 events, and the Adamu monobline group had 1 event The Adamu mono-resistance group had 6% (n-1) and ABBV-3373 group had 3% (n-1) discontinued treatment due to adverse events During the 12-week period of treatment, ABBV-3373 group of 4 patients (13% s.n?4) had severe adverse events (SAE) and the Adamu sepsis group was 0 cases (0% In the ABBV-3373 group, two SAE (pneumonia and upper respiratory diseases) were not considered to be related to the research drug 1 SAE is non-cardiogenic chest pain, 1 SAE is reported as anaphylactic shock, the patient has fully recovered, in the subsequent drug administration patients after the extension of the time of administration, no further reports of any allergy events "This proof-of-concept study demonstrates the clinical activity of the TNF-ADC platform and its potential to raise standards of care for patients with rheumatoid arthritis," said Michael Severino, Vice President and President of AbbVie Based on these results, we will promote the development of the TNF-ADC platform in rheumatoid arthritis and begin clinical studies in other immunomediated diseases "(BioValleyBioon.com) Original source: Novel Antibody Drug Conjugate ABBV-3373 Show Change in Disease Activity in Phase 2a Study of Patients with Rheumat Arthritis