Hi George,

Resverlogix has been working on their renal program for some time now. For example, here's a passage from one of their blogs from over a year ago:

"The analysis of the data collected from previous clinical trials of RVX-208 tells us that patients with type 2 DM and low HDL-c when treated with RVX-208 and rosuvastatin appear to benefit the most in terms of lowering major adverse cardiac events (MACE). In patients with type 2 DM and mild to moderate CKD, as reflected by a reduced eGFR, treatment with RVX-208 seems to stabilize the CKD. Another important observation is that a biomarker called alkaline phosphatase (ALP), an enzyme that is produced in several tissue types, is lowered by the actions of RVX-208. This finding is significant because, in the CKD population, ALP is one of the best biomarkers of not only CVD but also total mortality."

They established a renal clinical advisory board a couple of months ago. The chair, Dr. Kamyar Kalantar-Zadeh, is also on the BETonMACE committee.

The simple goal of this phase 1 is to "determine if apabetalone treated patients with severe renal impairment have the same favorable PK traits as has been witnessed in previous apabetalone trials." As stated above, previous trials only had patients with mild to moderate kidney disease. Therefore, this Phase 1 will hopefully open the door to being able to recruit patients with a wide range of kidney disease severity (from mild to severe) in their future trials without any worry of impaired kidney function affecting the metabolism of RVX-208 or creating any safetey issues.

It's a small and short trial. 16 patients, treated with a single dose of RVX-208 and followed for 3 days. It's not going to break the bank. And it will set the stage, hopefully, for the Phase 2 BETonRENAL trial next year. Check out their Q2 2016 Corporate Update presentation for a great description of the potential market for kidney disease with RVX-208. Very impressive.

Best regards,

BearDownAZ