AbbVie Announces Late- Breaking Results from Phase 2 Exploratory NOVA Trial of Novel Investigational Neurotoxin AGN- 151607 for the Prevention of Postoperative Atrial Fibrillation in Cardiac Surgery Cases

AbbVie Announces Late- Breaking Results from Phase 2 Exploratory NOVA Trial of Novel Investigational Neurotoxin AGN- 151607 for the Prevention of Postoperative Atrial Fibrillation in Cardiac Surgery Cases
Primary endpoint wasn’t met for the modified intent- to- treat( mITT) population; still, clinical benefit observed in coronary roadway bypass graft( CABG) cases
Data showed relative threat reduction in specific study populations and overall lower rates of rehospitalization within 30 days compared to placebo
Adverse Events( AEs) were numerically analogous across treatment groups
Results were presented moment as part of a late- breaking wisdom session at the 2022 American Heart Association Scientific Sessions
AbbVie( NYSE ABBV) moment blazoned new results from its exploratory NOVA phase 2 cure- ranging study assessing the efficacity and safety of AGN- 151607, a new investigational neurotoxin for the forestallment of postoperative atrial fibrillation( POAF) in cardiac surgery cases. The primary endpoint of assessing the circumstance of nonstop atrial fibrillation( AF) ≥ 30 seconds wasn’t met for the modified intent- to- treat( mITT) population; still, the data showed relative threat reduction in specific study populations, similar as coronary roadway bypass graft( CABG) cases and cases progressed 65 times and aged. The results were presented moment at the 2022 American Heart Association Scientific Sessions in Chicago, IL, USA, during the Late- Breaking Science session named” Treating Atrial and Supraventricular Arrhythmias.”

Among the observed benefits, relative threat reduction was seen in certain groups; specifically,pre-specified CABG cases treated with 125 units of AGN- 151607 entered the topmost benefit with 29 percent relative threat( RR) reduction compared to placebo( p = 0.15). In a post hoc analysis of CABG cases progressed 65 times and aged treated with 125 units of AGN- 151607, the study set up a lesser threat reduction at 51 percent compared to placebo( nominal p<0.01). Regarding rehospitalization within 30 days following discharge, cases treated with 125 units had lower rates of all- cause rehospitalization within 30 days compared to placebo(8.7vs.15.7, independently). In addition, at the time of this analysis, further cases on 125 units(62.9) were atrial fibrillation-free and anticoagulation-free versus placebo(45.1)( nominal p<0.05).

” Early studies have demonstrated POAF reduction using botulinum poison, and our end with the NOVA study was to further probe which cardiac surgery cases would show benefit,” said JonathanP. Piccini,M.D., Department of Electrophysiology, Duke Clinical Research Institute and Duke University Medical Center, Durham, NC, USA.” This trial was designed to explore cure, patient populations and outgrowth variables and wasn’t powered to demonstrate superiority for all clinically applicable differences, so we’re encouraged by the implicit observed in CABG cases.”

POAF is the most common complication following cardiac surgery, 1 leading to increased morbidity, mortality, increased length of sanitarium stay, healthcare application, and cost.2 The prevalence has not changed in decades, affecting between 30- 60 percent of cases witnessing cardiac surgery.3 presently, treatment options are limited, and there are no approved medicines for the forestallment ofPOAF.4

” We’re encouraged by the findings from the NOVA study, which was the largest neuromodulation study using a botulinum poison type A to help postoperative atrial fibrillation, and showed a implicit reduction of the threat to certain groups of cases,” said Mitchell Brin,M.D., Senior Vice President, R&D, and Chief Scientific Officer, Neurotoxins at AbbVie.” The data from this study suggest which case populations may profit from this intervention, and we look forward to exploring farther development openings.”

The proportion of actors passing any AE and rates of AEs leading to termination of the study were numerically analogous across the three treatment groups. There were two deaths in those treated with 250 units due to aorto- esophageal fistula( n = 1) and cardiac arrest( n = 1). Treatment- imperative cardiovascular AEs rates were heart failure(7.6,2.9, and3.7), stroke/ TIA(4.8,2.9, and1.8), myocardial infarction(1.9,1.0 and0.0), renal failure(6.7,4.8, and4.6), and respiratory failure(7.6,4.8, and5.5) for placebo, 125 units and 250 units, independently.

About AGN- 151607
AGN- 151607, a botulinum poison type A, is a new investigational neurotoxin being studied for the implicit treatment of atrial fibrillation.
About the NOVA Study
NeurOtoxin for the PreVention ofPost-Operative Atrial Fibrillation( NOVA) is a Phase 2, multicenter, randomized, double-eyeless, placebo- controlled, resemblant group, cure- ranging study to estimate the efficacity and safety of botulinum poison type A( AGN- 151607) injections( 125 units and 250 units versus placebo( 111)), into the epicardial fat pads to helpPost-Operative Atrial Fibrillation( POAF) in cases witnessing open- casket cardiac surgery. Randomization was stratified by type of surgery( presence or absence of stopcock surgery) and by age group(< 65, ≥ 65 times). Eligible actors were between 55- 90 times of age and witnessing open- casket cardiac surgery.

The primary endpoint of an AF occasion ≥ 30 sec during the first 30 dayspost-surgery wasn’t statistically different across the three treatment groups( mITT population). AF ≥ 30 sec passed in 47(46.1) of the placebo group, 38(36.5) of the 125 units group, and 50(47.2) of the 250 units group. Secondary endpoints looked at different delineations of AF, including longer durations of AF, similar as ≥ 4 hours, which passed in 33(32.4) of the placebo group, 25(24.0) of the 125 units group, and 28(26.4) of the 250 units group.

further information can be set up on https//clinicaltrials.gov( NCT03779841).

About AbbVie
AbbVie’s charge is to discover and deliver innovative drugs that break serious health issues moment and address the medical challenges of hereafter. We strive to have a remarkable impact on people’s lives across several crucial remedial areas immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across our Allergan Aesthetics portfolio.

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