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RVX: Business Update: 2018 Annual Shareholders’ Meeting

09/18/2018
By John Vandermosten, CFA

TSX:RVX

Operational Update

On September 12, 2018 Resverlogix Corp. (TSX:RVX) held its annual and special meeting of shareholders which included a presentation by CEO Don McCaffrey. The presentation updated investors on the trials in the pipeline and the status and near term expectations for BETonMACE.

Resverlogix is currently pursuing five different indications, including Acute Coronary Syndrome (BETonMACE), Chronic Kidney Disease, Fabry’s Disease, Vascular Cognitive Dementia and a new indication in Pulmonary Arterial Hypertension (PAH). Now that the company has been able to raise sufficient capital to advance some of the secondary trials, there is more certainty on progression and timing of results. Below we summarize their status and expected read out dates.


View Exhibit I - Pipeline Plan

The CKD and cognitive trials are slated to begin after data is available for BETonMACE. The company will analyze the renal and cognitive dementia subpopulation data in the BETonMACE trial before finalizing the trial design for these studies. Third party work has been done in PAH supporting additional study and prompting a trial by Resverlogix that will begin in the third quarter of next year. There may be external funding to explore potential for apabetalone in PAH. In the three most explored areas which include the high risk populations of ACS and CKD and dementia patients, Resverlogix has conservatively identified 12 million patients in the top eight markets that may benefit from apabetalone.


View Exhibit II - Key Indications and Addressable Population

BETonMACE

The BETonMACE trial has been fully enrolled since February 2018 and additional enrollment was allowed at Chinese sites to allow for additional flexibility with regulatory authorities. Enrollment in China continued until June. More than 1,900 patients have been dosed in all apabetalone trials with seven Data and Safety Monitoring Board (DSMB) meetings all recommending that the trial continue as designed. No safety or efficacy concerns were raised in the reviews. There will be one additional DSMB meeting before the trial is concluded.

The BETonMACE trial had originally intended to run until 250 major adverse cardiovascular events occurred. As we discussed previously, the events have occurred at a slower pace than that indicated by historical event rates in this population, delaying the 250 event milestone by a few months. This may be a favorable result for the apabetalone arm in the trial or it could be a healthier population overall contributing to the slower death rate. As of September 12, the MACE event rate was approximately 200 and events are occurring at a rate of 10 – 15 per month. Resverlogix has also decided to continue dosing until 250 events have occurred, which suggests that there could be ~270 events when the trial closes, improving the statistical powering in comparison with the original protocol. These historical numbers suggest that the trial can begin the adjudication process around the beginning of the year. While clinical events are independently assessed over an anticipated two month period, additional events will be added providing a topline readout around March 2019.

Summary

We are in the final stretch for Resverlogix’s Phase III BETonMACE trial and should achieve the target event rate near the turn of the year. To increase the power of the trial, Resverlogix will allow BETonMACE run a couple months longer after 250 events occur. The company will also skip the sample size re-estimation analysis, which will remove a statistical penalty and improve p-values. While the trial will take several months longer than originally anticipated, we see this as a risk reduction technique that is well worth the additional time investment. Now that there is clarity on events and trial conclusion, we anticipate interest will increase in the stock as we close on a read out date. Our previous report is available here where we discuss valuation, indications, additional trial detail and achievements in 2018.

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