Re: Resverlogix’s BETonMACE Phase 3 Epigenetics Trial Completes Final Safety Visits
posted on
Jul 08, 2019 09:36AM
Awesome news! I'm not too surprised by the September timeline for BETonMACE top-line data stated in today's news release. Trial wrap up takes time.....several months. Although many of us, including me, acknowledged that an earlier timeline for top-line data was in the realm of possibilities, the September timeline is more in line with trial wrap up times for other recent CVOT trials. Back in the April 18th news release, they projected that it would be 2 to 4 months until top-line, which stretched the projection to August 18th. Now, it seems like the top-line projection is ~2-6 weeks beyond that to cover September beginning to end. Look at timelines for trial wrap up for past CVOTs and you shouldn't be too surprised by the timeline stated today. Par for the course.
We already knew that there weren't any BETonMACE full data presentations for the primary outcome at ESC or EASD based upon the announced conference schedules, so the projection of full data during the November meetings (i.e. AHA, ASN) is still intact (see event list here). And we shouldn't expect any BETonMACE trial data (cardio, cognition, or renal) prior to top-line data, in my opinion. So next week's AAIC meeting presentation likely won't contain anything too exciting, in my opinion.
ESC Aug 31 to Sept 4 will be a good set up to get folks ready for top-line. IR previously communicated that their goal was to get a BETonMACE trial design and rationale paper published prior to top-line data. Possibly this publication gets published around the time of the ESC presentation on Sept 2 "BET-inhibition with Apabetalone in Post-ACS Patients with Diabetes: Design and Baseline Characteristics of the BETonMACE trial." And the ESC 2019 symposium "Epigenetics: A new pathway to tackle residual risk?" will be another great exposure opportunity prior to top-line.
BearDownAZ