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Resverlogix Corp T.RVX

Alternate Symbol(s):  RVXCF

Resverlogix Corp. is a Canada-based late-stage biotechnology company. The Company is engaged in epigenetics, with a focus on developing therapies for the benefit of patients with chronic diseases. Its epigenetic therapies are designed to regulate the expression of disease-causing genes. The Company's clinical program is focused on evaluating its lead candidate apabetalone (RVX-208) for the treatment of cardiovascular disease and associated comorbidities, and post-COVID-19 conditions. RVX-208 is a small molecule that is a selective bromodomain and extra-terminal (BET) inhibitor. BET bromodomain inhibition is an epigenetic mechanism that can regulate disease-causing genes. RVX-208 is a BET inhibitor selective for the second bromodomain (BD2) within the BET proteins. It partners with EVERSANA, to support the commercialization of RVX-208 for cardiovascular disease, post-COVID-19 conditions, and pulmonary arterial hypertension in Canada and the United States.


TSX:RVX - Post by User

Bullboard Posts
Comment by BearDownAZon Apr 07, 2019 8:17am
147 Views
Post# 29593224

RE:RE:Patient years

RE:RE:Patient yearsG1945V and Anthonyevans, Resverlogix provided the 8 per 100 patient year figure about a year ago in their investor presentation slide decks. That was right around the time of full enrollment and importantly was a blinded figure that included both placebo and apabetalone. That was simply a snapshot in time of the average observed MACE rate. Considering that the risk of MACE is highest for an individual patient in the first several months post-enrollment, and also considering that the BETonMACE protocol was amended to allow for dosing beyond the originally planned two years, it makes sense that the average observed MACE rate would have dropped between then and now. The AHA BETonMACE poster from 2018 stated that the placbo group has an assumed MACE rate of 7 per 100 patient years. If that holds true, and apabetalone group has a MACE rate of below 7, consistent with apabetalone MACE benefit, then the observed average MACE rate for the blinded data will be well below 7. As for comments about the longer the trial goes, the better this may be for predicting apabetalone MACE reduction........as I have stated several times there are too many unknowns to assume this. BETonMACE was designed to yield 250 events with 3600 patient years. We don't know how many patient years there are right now. If at or below 3600, then the trial has not exceeded planned patient years yet. Only if BETonMACE is beyond 3600 patient years can one start with the longer the better logic, in my opinion. Another unknown is the placebo event rate. EXAMINE and ELIXA provided good examples of high risk diabetics with recent ACS event. But I think these ranged between ~6.5 and 8 per 100 patient years. How much will the low-HDL requirement affect rates? Has standard of care improved since EXAMINE and ELIXA? How reproducible are EXAMINE and ELIXA? What will be the Apabetalone %RRR. Way too many unknowns to predict Apabetalone efficacy even if we knew the patient year status and average event rate, in my opinion. BearDownAZ
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