VIA Pharmaceuticals has met FDA for its lead drug, VIA-2291 (atreleuton). The company has reviewed safety and biologic activity data from the Via-2291 phase 2 CEA and ACS trials with the FDA and received guidance including suggestions from the Agency on the phase 3 trial design.
The company’s phase 3 cardiovascular outcome 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, said the company.
Moreover, the guidance from the FDA will be incorporated into the Via-2291 registration and phase 3 program, and the company intends to submit its proposed phase 3 plan to FDA including a request for a Special Protocol Assessment.
Larry Cohen, President and CEO of VIA, said: VIA-2291 specifically targets the inflammation in atherosclerotic plaque that is thought to trigger major adverse cardiac events. Our positive Phase 2 data demonstrate VIA-2291’s potent inhibition of leukotrienes, lowering of hsCRP, and the potential for plaque stabilization as demonstrated by reduction in carotid plaque inflammation and non-calcified coronary plaque volume. 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.”