Anthera Pharmaceuticals (NASDAQ:ANTH) recently recruited their first subject into the VISTA-16 Phase 3 Trial (Evaluation of Safety and Efficacy of Short-term A-002 Treatment in Subjects with Acute Coronary Syndrome). Product A-002 is also known as varespladib methyl.
Varespladib methyl is a SPLA2 inhibitor and can be characterized as a systemic anti-inflammatory. While products developed for indications like acute coronary syndrome (ACS) have the potential to be blockbusters, the VISTA-16 trial design raises a number of questions regarding its ability to obtain successful reimbursement and market access in the US. Below, I outline 3 key hurdles.
Issue #1: Comparator Selection
VISTA-16 compares (varespladib methyl + atorvastatin + standard of care) to (placebo + atorvastatin + standard of care). In the ACS marketplace, aspirin and clopidogrel bisulfate (Plavix) are arguably the gold standard therapies. Both prasurgrel (Effient) and ticagrelor (Brilinta) conducted head-to-head studies against Plavix in ACS. Therefore, Anthera may not have chosen the optimal comparator for their VISTA-16 trial.
Impact: Without the appropriate comparator, varespladib methyl may face a significant market access hurdle. That is, payers may require products like generic Plavix and even prasugrel be used BEFORE the subject is allowed to obtain varespladib methyl.
Issue #2: Endpoint Selection
The primary endpoint of the VISTA-16 trial measures the combined components of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or documented unstable angina with objective evidence of ischemia requiring hospitalization. The first three components encompass the traditional ‘hard’ endpoints of MACE (Major Adverse Coronary Event) whereas the forth component is considered a ‘softer’ endpoint.
Impact: Payers prefer to see efficacy results for ‘hard’ endpoints. Therefore, the addition of the ‘softer’ endpoint to the combined primary endpoint may reduce the robustness of the results, especially if each component of the combined primary endpoint is analyzed individually.
Issue #3: Trial Duration
In VISTA-16, varespladib methyl is administered for 16 weeks with survival status checked at 6 months after the subject completes the study. This is a relatively short treatment window.
Impact: Some payers may limit the use of varespladib methyl to 16-weeks.