Friday, January 12, 2018
Resverlogix Corp. and the Resverlogix BETonMACE Clinical Steering Committee (CSC), represented by Professor Kausik Ray (Chair), are pleased to announce the FDA acceptance of the Company’s Phase 3 BETonMACE trial Protocol amendments.
On behalf of all members of the BETonMACE CSC, Professor Kausik Ray welcomed the addition of US-based sites to the ongoing cardiovascular disease (CVD) outcomes trial, BETonMACE. The BETonMACE trial will now be expanded beyond Europe, Asia and South America to a fourth continent – North America with the addition of the United States. Prof. Ray commented, “The addition of the United States is timely as we plan to conduct a Sample Size Recalculation Analysis ('SSRA') later in the first half of 2018. BETonMACE is currently targeted to include 2,400 participants to yield 250 MACE events and this number may be increased if required. Enrolling patients from the major regions of the world will provide evidence of generalizability in different healthcare systems and in different populations should apabetalone show improvement in cardiovascular outcomes. The FDA acceptance of the BETonMACE trial in US centers is an important milestone in the development of this compound.”
Further, Mr. Donald McCaffrey, President and Chief Executive Officer, stated, "I am extremely pleased with the continued progress of the BETonMACE trial. We have already enrolled over 2,200 patients and expanding territories and potentially number of patients beyond 2,400 may be beneficial in several ways, scientifically and commercially. BETonMACE top line data is still planned to be available around the end of 2018.”
