Resverlogix’s apabetalone diabetic population target strikes expert debate on Phase III CVD trial significance; unmet need, clean tolerability could aid approval if efficacy is met
Resverlogix's (TSE:RVX) apabetalone for reducing cardiovascular disease (CVD) event risk has experts debating whether its targeting of diabetic patients with impaired kidney function could backfire in a Phase III trial, reducing its approval prospects. One expert noted this is a difficult population to study, however others added the company has some post-hoc data supporting usage in these patients.
An unmet need, though, to reduce CVD risk in patients with diabetes and impaired kidney function could help sway future approval decisions, experts said. But some noted the FDA may have reservations about apabetalone's anti-inflammatory mechanism to mitigate CVD potential, drawing approval pause.
Experts discussed the positive Phase II SUSTAIN (NCT01423188) data, which showed an improvement on HDL. Some experts noted this was ultimately unimportant with CVD risk reduction, drawing doubt if the drug has the right data for approval. If the Phase III results are positive, the drug's excellent safety and tolerability profile, which is expected to continue, should contribute to a positive FDA review.