Phase II ATTRACT-22 study shows benefits for lung injury with C 21 in COVID-19.- Vicore Pharma

The new results are based on high-resolution computerized tomography (HRCT) scans from a 3–6-month non-interventional, retrospective follow-up trial, ATTRACT-22. This study included a subset of 33 patients with COVID-19 participating in Vicore's phase II ATTRACT trial. The C21-treated patients (n=17) displayed reduced pathological abnormalities compared to the placebo-treated group (n=16); in the C21 group, on average 10.3% of the lung was affected compared to 19.2% in the placebo group. The dominating radiological change was ground glass opacity, a pathological characteristic following viral respiratory infection. Although functional tests were not performed in this study, it is known that reduced gas exchange is a common lung function abnormality in COVID-19 patients with an abnormal HRCT at three months.

Lung injury scores were assessed by an independent blinded radiologist experienced in HRCT scan reading at a national center for thoracic disease in the UK. Scores were cumulative totals of conventional lung injury types commonly assessed by radiologists. Follow-up HRCT scans were recorded as part of local clinical practice at follow-up visits performed 90-170 days after the 7-day treatment period in the ATTRACT trial in patients who had received either C21 or placebo on top of standard-of-care including steroids and the antiviral remdesivir. This could be the first time effects of pharmaceutical intervention on long-term lung injury after COVID-19 is reported.

The results of the ATTRACT trial were recently published in EClinicalMedicine, a peer reviewed clinical journal published by The Lancet, and are available online via this link. The randomized, double-blind, placebo-controlled trial showed that C21 on top of standard of care significantly reduced the proportion of COVID-19 patients requiring supplemental oxygen, indicating faster patient recovery compared to placebo. The pivotal phase III ATTRACT-3 trial design was approved by the FDA in June 2021 and is currently recruiting patients in US, Czech Republic, Ukraine, India, South Africa, and Philippines. ATTRACT-3 is a randomized, double-blind, placebo-controlled, global, phase III trial which will include 600 adult patients hospitalized with COVID-19 requiring oxygen support but not mechanical ventilation. This is a patient category that is different from those being addressed by antivirals. The primary objective is to evaluate the effect of C21 on recovery from COVID-19. ATTRACT-3 is expected to deliver top-line data in H1 2022.