VIA Pharmaceuticals has met FDA authorities for guidance on the next phase for its lead cardiovascular drug VIA-2291 (atreleuton).
The company reviewed safety and biological activity data from the Via-2291 phase 2 CEA and ACS trials with the FDA and has received guidance including on the phase 3 trial design.
The phase study will assess the effect of Via-2291 in preventing cardiovascular events such as heart attack, stroke and cardiovascular mortality in patients with recent heart attack and/or established atherosclerotic cardiovascular disease.
Guidance from the FDA will also be incorporated into the Via-2291 registration and phase 3 programmes.
The company intends to submit its proposed phase 3 plan to the FDA including a request for a special protocol assessment.
VIA president and CEO Larry Cohen said VIA-2291 specifically targets the inflammation in atherosclerotic plaque that is thought to trigger major adverse cardiac events.
“We believe this compound is now ready for testing in a broad outcome phase 3 trial that may establish a link between inflammation and reduction of these major adverse cardiac events,” Cohen said.
