Isotechnika Pharma has released the results of the Confirm1 clinical trial conducted by its medical device partner, Atrium Medical to evaluate Atrium's drug eluting coronary stent coated with Voclosporin.
Confirm1 clinical trial showed that the drug coated stent was safe as it had no statistical difference in safety events compared to the bare metal stent.
However, the drug coated stent did not demonstrate improved efficacy in terms of angiographic late lumen loss when compared to the bare metal control stent.
Isotechnika Pharma said that the additional analyses of the intravascular ultrasound (IVUS) imaging suggested that there is a potentially important interaction of the Voclosporin and Atrium’s proprietary coating found in patients identified with unstable lipid pools within their coronary arteries.
The company stated that additional research would be required to elucidate these observations.