- 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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