VIA and FDA Meet on Cardiovascular Drug

14 June 2009 (Last Updated June 14th, 2009 18:30)

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

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.