Vicore amends primary endpoint to accelerate the Phase 3 trial in COVID-19 patients
- Based on the profile of C21 and emerging COVID-19 data, the ongoing Phase 3 trial has been amended to revise the primary endpoint and reduce sample size
- The amendment has been adopted to reflect the current SARS-CoV-2 virus landscape and will accelerate study completion
- Expected read-out during Q3 2022
Gothenburg, June 3, 2022 – Vicore Pharma Holding AB (publ) (“Vicore”), a clinical-stage pharmaceutical company developing medicines targeting the angiotensin II type 2 receptor (AT2R), today announces an amendment of the ongoing COVID-19 Phase 3 trial (ATTRACT-3).
In response to the current dominance of the weaker Omicron variant of the SARS-CoV-2 virus, leading to fewer hospitalizations, Vicore has gained FDA endorsement to revise the hierarchy of endpoints in the ongoing ATTRACT-3 trial*. The revised primary endpoint, all-cause mortality up to day 60, is supported by the previously reported Phase 2 trial (ATTRACT) results, is clinically relevant and adopted to the study population.
In the ATTRACT trial, C21 restored respiratory function and improved disease severity, as demonstrated by 1) a significant reduced need of oxygen supplementation, 2) a reduced number of patients needing mechanical ventilation, 3) a reduction in mortality and 4) a clinically and statistically significant reduction of NT pro-BNP, a strong biomarker predicting severity and mortality in COVID-19. These results have positioned C21 as a treatment for hospitalized patients with moderate to severe COVID-19 to restore respiratory function and prevent progression of severity and mortality.
The ATTRACT-3 trial is approaching 300 patients enrolled and includes a large initial population of unvaccinated patients infected by the Delta variant, justifying the change to a mortality endpoint and to complete the trial with this sample size. Top-line data will be presented in Q3 2022.
“C21 have shown significant effects in reducing disease progression in hospitalized moderate to severe COVID-19 patients why the amended endpoint is highly relevant and will increase our chances of a successful trial” says Carl-Johan Dalsgaard, CEO in Vicore.
About angiotensin II type 2 receptor agonists (ATRAGs)
AT2R is part of the body’s regeneration and repair system and is suggested to be involved in several diseases connected to ageing and cell senescence including idiopathic pulmonary fibrosis, chronic kidney disease, heart failure and cognitive disorders. Stimulating the AT2R have been shown to be effective in several disease models and the clinical validation is under way in acute and chronic lung disease. Stimulation of AT2R can also dilate small resistance vessels in animals and man to locally increase blood flow.
For further information, please contact:
Carl-Johan Dalsgaard, CEO
Phone: +46 70 975 98 63
E-mail: carl-johan.dalsgaard@vicorepharma.com
This information was submitted for publication on June 3, 2022 at 08:00 CET.
*NCT04880642