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Resverlogix NYAS Symposium notes

posted on Apr 29, 2016 12:50PM

Some notes of mine from the NYAS webcasts yesterday for Resverlogix's presentation by Ewelina Kulikowski. My notes from the Zenith Epigenetics' presentation by Eric Campeau can be found here. Both were great talks that were extremely science heavy that justified current ongoing and planned trials. Ewelina's presentation was similar to the science-heavy format of the September 2015 Research and Development update.This was not an investor conference, so no info on regional deals, recent personnel changes, financing, follow-on drug candidates or trial timelines. Enjoy!

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Resverlogix at NYAS 4/28/16 presented by Ewelina Kulikowski:

Strong emphasis on RVX-208 being selective for second bromodomain as opposed to pan-inhibitors that binds to both BD1 and BD2. Also, much emphasis on RVX-208 localizing to liver cells as opposed to other BET inhibitors, which have a wide tissue distribution. RVX-208 reaches about 1-2 uM concentration in vasculature, whereas concentrations in liver are about 30 uM (30 uM in liver found in mouse studies). This is why RVX used 30 uM concentration of RVX-208 in cell culture/ex-vivo studies. Ewelina did a great job emphasizing these points and distinguishing RVX-208/apabetalone from all other BET inhibitors out there.
Great overview of phase 2 clinical data to date with primary emphasis on MACE in diabetic and high hsCRP patients. BETonMACE phase 3 trial only briefly discussed. A lot of discussion on pathway analysis of microarrays in primary human hepatocytes and whole blood samples treated w/ or w/o RVX-208. Pathways affected include complement cascade, acute phase response, coagulation/fibrin clotting cascade, inflammation and calcification. Also some discussion of alkaline phosphatase changes and their clinical implications. Importantly, despite RVX-208 eliciting robust changes in the above pathways, RVX-208-treated treated patients not experiencing bleeding events, infections, infestations, immuno-compromising.
Newest data was the collaboration between Resverlogix and SomaLogic out of Boulder, CO. Patient blood samples (not sure if plasma, serum or whole blood) from the 12-week ASSERT study and the longer 24-week SUSTAIN/26-week ASSURE studies (might have been just one of these trials) were analyzed by SomaLogic's SOMAscan Proteomic Assay. This SOMAscan is a multiplexed proteomic assay allowing for the assay of ~1310 protein analytes by using single stranded DNA based aptamers that bind to and allow for quantification of native proteins. Lots of changes found between the RVX-208 treated patients and placebo group that they are still sorting through, but Ewelina focused on the compliment, coagulation and acute phase response changes. There was a lot of data presented so I won't list it here, but it will suffice to say that a lot of changes were observed that are statistically significant that support their previous findings. Changes were observed at both 3-months and 6-months of treatment, with even greater changes at 6-months. This is really important because now they have proteomic data from blood of RVX-208 treated patients that supports the gene expression changes found in the microarrays. Furthermore, Ewelina discussed a functional compliment assay that they performed with whole blood exposed to a complement pathway stimulus. This showed that RVX-208 treated blood exhibited a statistically significant 26% reduction of the complement cascade, further supporting the microarray and SOMAscan results.
An ALT adverse event question was asked during the Q&A session. Ewelina emphasized that this is only seen in 6-7% of patients and only during a transient treatment window of 6 to 12 weeks. Patients are able to dose right through it and then it goes down. The ALT increase is benign with no damage to the liver.
Last note. In the discussion of other applications of RVX-208, not only were compliment-mediated disease and kidney disease listed, but also muscular dystrophy and liver fibrosis. I think they may have mentioned the liver fibrosis before, but if I'm not mistaken this is the first time I've heard mention of a muscular dystrophy application.