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FDA on board with Resverlogix BETonMACE study

Published 06/14/2018, 04:25 PM
© Reuters.  FDA on board with Resverlogix BETonMACE study
  • Resverlogix (OTCPK:RVXCF) announces that the FDA has confirmed that its statistical analysis plan and endpoints for the large-scale Phase 3 BETonMACE study to assess the cardiovascular benefits of lead drug apabetalone in cardiovascular disease patients with type 2 diabetes and low high-density lipoproteins ("good" cholesterol) should be sufficient to support an NDA filing and approval.
  • The company adds that the specific indication will be determined by the study results.
  • Apabetalone works via an epigenetic mechanism called BET (bromodomain and extra-terminal) inhibition which regulates disease-causing genes. It specifically inhibits the second bromodomain (BD2) within the BET protein called BRD4, thereby producing a potential treatment benefit in patients with CV disease, diabetes, chronic kidney disease, Alzheimer's and other conditions.
  • Previously: Resverlogix completes enrollment in late-stage study of lead drug apabetalone; data readout by year-end (March 19)
  • Now read: Autolus Therapeutics Readies 5 Million U.S. IPO


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