Caristo Applauds Abcentra for Successful Phase 2b Trial Start
‘FORTIFY’ Selects FAI-Score
as Primary Outcome Measure, and Caristo as Worldwide Imaging Core Lab for Coronary Inflammation and Plaque Measurement and Monitoring
Caristo Diagnostics, on a mission to rework the analysis and therapy of heart problems, right this moment, congratulates Abcentra for the profitable dosing of the primary affected person within the FORTIFY medical trial (https://clinicaltrials.gov/examine/NCT06927739), and proclaims Caristo’s function as FORTIFY trial’s worldwide imaging core lab. For the FORTIFY medical trial, Caristo oversees all coronary irritation and plaque measurement and monitoring, in addition to contributes to affected person choice via its proprietary CaRi-Heart® and FAI-Score applied sciences.
The FORTIFY medical trial (Focused Orticumab Research for Treating Inflammation in Coronary Arteries; NCT06927739) is a multi-center, randomized, placebo-controlled, double-blind trial designed to judge the efficacy of orticumab in decreasing native coronary irritation in sufferers with a historical past of sort 1 myocardial infarction (MI) and elevated coronary irritation. A complete of 240 adults with a historical past of sort 1 MI and elevated Fat Attenuation Index (FAI) Score — decided utilizing Caristo’s CaRi-Heart expertise — are being enrolled at 40 websites within the U.S. and Europe.
Caristo’s core laboratory obligations for the FORTIFY trial embrace:
- Certifying and coaching every medical website to make sure high-quality coronary computed tomographic angiography (CCTA) imaging
- Supporting affected person enrollment by figuring out eligible candidates primarily based on elevated coronary irritation as measured by FAI-Score, an AI-powered imaging biomarker that’s an unbiased predictor of future main adversarial cardiovascular occasions
- Conducting baseline and follow-up analyses for all randomized sufferers at 24 weeks
- Quantifying coronary irritation utilizing CaRi-Heart expertise, which leverages the FAI-Score
- Providing complete cardiovascular danger calculations, plaque evaluation utilizing CaRi-Plaque, picture high quality management, and radiation dose optimization
“We selected Caristo as a result of their cutting-edge imaging expertise permits us to measure coronary irritation with unprecedented precision,” mentioned Christopher Farina, CEO of Abcentra. “This might be very important to confirming orticumab’s potential to handle coronary irritation, one of many root causes of coronary heart assaults.”
“Pharma and biotech sponsors are more and more turning to Caristo to assist choose trial candidates and consider how each coronary plaque and irritation — two crucial and unbiased predictors of coronary heart assault danger — are affected by a trial drug,” mentioned Frank Cheng, CEO of Caristo Diagnostics. “We are proud to accomplice with Abcentra on FORTIFY and to help their groundbreaking work in creating focused anti-inflammatory therapies with FAI-Score chosen as the first consequence endpoint.”
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