Can Resverlogix's Apabetalone Succeed Where Biogen's Aducanumab Failed?

Disclosure Right Up Front

I don't like burying disclosure statements at the bottom of a post, especially when I'm long.  

I am a shareholder in Resverlogix which trades in Canada with the symbol RVX.TO or in the US (RVXCF) and hold what for me represents a very significant position, in fact its my single largest holding. As such anything I write should be viewed as having bias and consequently this blog posting should be viewed as being for entertainment purposes only.

While I endeavor to ensure that any data and information posted is factual I make no guarantees to that effect and recommend that readers verify any and all information posted.

I am not a registered investment advisor and stocks comport significant risk. Engagement of a professional is strongly advised before making any investment.

Can Epigentics unlock a treatment for Alzheimer's?

While it appears that Biogen's (BIIB) attempt to prove Aducanumab's potential to treat Alzheimer's has failed that doesn't mean the search for a treatment is over.  

Followers of Biotech have no doubt come across the term Epigenetics.  In a nutshell its the level above the genes, Epi being Latin for above.  Rather than altering genes it involves what has been described as a switch, turning genes from a diseased state to a healthy state by means of transcription.  

Resverlogix's Apabetalone is a compound that is currently in a Phase 3 events based trial that is projected to be wrapping up sometime in the next few weeks.  Because of something called the 'Complement Cascade' it is believed that Apabetalone may have the potential to impact a myriad of conditions, one of which is Alzheimer's.  

BETonMACE Phase 3 Trial of Apabetalone

BETonMACE is a Phase 3 trial that has been running since October of 2015 and is projected to wrap up sometime in April with top-line results expected sometime around mid year (June 30th 2019).  

While the primary outcome is not related to Alzheimer's there is a subset of patients aged 70 years and higher who are undergoing the Montreal Cognitive Assessment (MoCA) at various stages during the trial to determine whether or not Apabetalone has the potential to impact cognitive impairment which can result from conditions like Alzheimer's and Vascular Dementia.  

Here is a news release speaking directly to this subgroup of patients.

Resverlogix Presents at Clinical Trials in Alzheimer's Disease (CTAD) Asia 2018

As noted in that PR, of the roughly 2,400 patients enrolled in the trial approximately 450 patients are aged 70 years and older.  Further about half of those 450 older patients had MoCA scores below 25 which is indicative of mild cognitive impairment.  

Please note that while that PR from Sept 2018 had the trial projected to finish around the end of 2018, that projection has now been moved forward to April as mentioned previously.  

What happens if those dosed with Apabetalone show improved MoCA scores?

As noted earlier, the primary end point of the BETonMACE trial is not Alzheimer's or Vascular Dementia.  The primary end point is about measuring the time to first occurrence of a Major Adverse Cardiac Event, (MACE for short) in patients with Diabetes Mellitus. Resverlogix is hoping to prove that Apabetalone in tandem with Standard of Care (Soc) will show a statistically significant Relative Risk Reduction versus placebo with SoC.

If the sub analysis of patients over the age of 70 demonstrates positive benefits in regards to MoCA scores, then I fully expect there would be further clinical trials designed with a goal of measuring cognition.  

Summary

As with many of my blog posts I like to stress that Seeking Alpha should obviously never be the end of someone's research and due diligence.  If this is your first introduction to Resverlogix and Apabetalone I will provide some links, and I welcome any commentary or questions below.  

Currently there is no US listing for the company's shares, so those without access to Canada's big board TSX who trade over U.S. exchanges must use the OTC platform where the company's ticker symbol is RVXCF.  The company has engaged Paris based Rothschild & Co in efforts to secure a U.S. listing however nothing as yet has come of that.  

Here is a chart showing the performance of RVXCF for the past year.  

Here is the link to the trial information at clinicaltrials.gov

Effect of RVX000222 on Time to Major Adverse Cardiovascular Events in High-Risk T2DM Subjects With CAD - Full Text View - ClinicalTrials.gov

And here's a link to an article on Apabetalone from The Journal of The Alzheimer's Association:

https://www.alzheimersanddementia.com/article/S1552-5260(18)30893-8/abstract

Again, comments are always welcome.