Post by Yelk on Jan 25, 2015 6:43:50 GMT
Reservlogix(RVX)
• RVX-208 addresses a highly unmet clinical need for 70% or more of cardiovascular patients that points to a large upside to shareholders from current share price of 84 cents
• Patients with low HDL, chronic inflammation and diabetes have responded well to RVX-208 with safety data in over 1,000 patients and as high as 77% reduction in MACE
• P3 Trial Bet on Mace to start 1H 2015, the structure of trial suggests a high chance for success as primary endpoint has already been achieved numerous times in 6 months versus the trials minimum 12 month period. FDA registration requirement endpoints have already been surpassed in what I believe is fair analysis
• The current position of the company suggests it is undervalued as it will be running a unique cardiovascular trial of 1600 minimum patients versus 20,000, it will have one P3 trial instead of possibly 2; overall cut costs and time to commercialization
• Pipeline is icing on the cake, full direction and update Q2 2015, possible orphan designations, strong patents in multiple countries past 2030
• New leadership from RVX-208 Mike Sweeny from Pfizer
• Recently completed financing of $32M U.S. (40M Canadian)
RVX-208
RVX-208 is a first-in-class, small molecule selective BET bromodomain inhibitor. BET-Bromodomain inhibition is an epigenetic mechanism that can turn disease-causing genes either on or off, returning them to a healthier state. RVX-208 is the first and only BET inhibitor selective for BRD4-BD2, producing a nexus of biological effects with important benefits for patients with disease such as cardiovascular disease, diabetes mellitus, Alzheimer's disease, peripheral artery disease, and chronic kidney disease while maintaining an excellent safety profile. Resverlogix is planning to study RVX-208 in a proposed Phase 3 clinical trial in CVD patients with diabetes mellitus and low HDL. Dr James D. Watson co-discovered of DNA wrote his first solo article 2 years ago since 1972 has said this is perhaps the most important discovery since DNA. BRD4 as a target. Some of his comments can be found here. RVX-208 has been approved to be tested in 12 countries and has been in 1,000 patients. This represents a strong safety profile. It has demonstrated an ability to reduce MACE as high as 77% in diabetic patients and over 50% average. No other drug has shown strong MACE nor has been able to demonstrate it in such a short timeframe. Usually it would take years with thousands of patients whereas Reservlogix was able to demonstrate it with 498 patients in 6 months. Currently the company is collaborating with Emerald Logic to determine what is driving these amazing results.
Market Potential
As shown in the company’s latest presentation a study done by Deutsche Bank gave a cardiovascular industry update for current available treatments. Listed were Torceptrapib valued at $13.1 Billion, Dalcetrapib at $8.2 Billion and Darapladib at $9 Billion. None of these treatments have gone well and nor have they or any other treatment shown MACE reduction. Clearly a drug addressing the problem is worth a lot of money. The market size for patients stands at 6.7M chronic kidney disease, Diabetes with low HDL at 7.6M and high risk vascular disease with low HDL at 4.5M, totaling 18.8M and with no major competitor. I am not an analyst so for reasons to not overdo this article I will refrain from doing an analysis of what this company could be worth for RVX-208 alone without its pipeline.
In Saudi Arabia over 21% healthcare budget spend on diabetes, China 25 billion, 13% overall cost, 10% of Chinese population has diabetes, Russia as well and these Numbers are growing. These are big markets. This is the first company ever to reduce MACE in diabetic population by 77% (or at all) - statistically significant to .01. I believe this could be a blockbuster and if commercialized take priority over any existing competition. Lipitor one of the best drugs on the market currently has 37% relative risk reduction.
Getting past the FDA
The company has great direction to take trial in and what I believe to be straightforward FDA ruling for phase 3 when looking at recent data. FDA guidance is actually helpful to the company because it can register under diabetes program and doesn't have to go cardiovascular route which is very expensive and lengthy. For diabetic trials you must show HBA1C reduction of .5 or greater which RVX has already achieved and Reservlogix has to show no more than 30% increase in MACE - RVX-208 shows 77% DECREASE. In registry trial you can go up to .8% increase in showing mace but wouldn't get registered, if you had 1.2% and reduction in hemoglobin you can get approved. RVX endpoint goal for P3 is 20-30% reduction MACE, the last 3 trials have been 55%, 60% and last 77% reduction. MACE is defined as death, heart attack, stroke, hospitalization etc.
Structure of unique P3 Trial Bet on MACE
1600-2500 patients 1:1 to placebo, blind, over 20 countries. Most everything is already planned and the details are being sorted of which we should see announced shortly. What makes this trial unique is that the company is able to cut costs and time frames and will set an endpoint they have already achieved with patients they know react well to the drug. This sets the bar high for success in my opinion. (Refer to getting past the FDA)
Strong Leadership
Resverlogix has a very strong management team and I believe with the new addition of Michael Sweeney they have what it takes to see their drug brought to the market.
On Nov. 3, 2014 Resverlogix announced the appointment of Michael T. Sweeney, M.D., as senior vice president of clinical development. Dr. Sweeny has extensive experience in product development and will oversee clinical development programs for RVX-208 in all indications. As Resverlogix steams forward with their phase 3 trial set to begin enrollment in 1H 2015 they also plan additional trials to evaluate the drug in Alzheimer’s disease, PAD and chronic kidney disease.
Dr. Sweeny has 11 years’ experience at Pfizer where he oversaw many of the Viagra® clinical trials. Sweeney was also the Vice President of Medical Affairs at CV Therapeutics, Inc., where he built the medical affairs department to enable the successful launch of Ranexa® for patients with cardiovascular disease and chronic angina. Prior to Impax, Dr. Sweeney was Chief Medical Officer and vice president of research and development at Depomed, Inc., where he implemented the company's strategic plan for product development activities including opportunity assessment, clinical trials and interactions with the FDA. The management team also has other experienced individuals from Roche and co-developer of Lipitor. Donald McCaffrey is Co-Founder, President, & Chief Executive Officer (CEO) of Resverlogix Corp. He has over 35 years of business experience including 15 years of drug discovery & development. His expertise and experience is what has brought this team together over the years.
A rich on the side pipeline
In the next trial for phase 3 Bet on mace, 15% will have chronic kidney disease which will lead provide major research for Phase 3 chronic kidney disease trials and shorter phase 3 PAD trails, discussion NIH for Alzheimer’s funding is still underway and is a smaller 20 patient trailer. Phase 3 orphan drug status may be announced later this year for products in pipeline. All of these announcements should happen in 2015 and direction if expected starting in Q2. RVX-208 has the potential to be a blockbuster and I believe due to its nature could get funding from government level due to lowering current cost of care. I also believe it is possible due to outstanding results 6 months into the 18 month trial the drug could be fast tracked and approved for ethical reasons.
Conclusion and Recommendation
RVX-208 is obviously the bread and butter for Resverlogix and because of this the largest potential is risk of failure in the Bet on Mace trial. From the current market cap however I believe Reservlogix represents a good opportunity with a low risk and high reward profile. When assessing the multi-billion market potential with a short period to commercialization and a strong management team, financed with a high chance of trial success and excellent previous trial data one can only conclude that nobody has noticed this Canadian company or completely forgot about it. I would like to note on March 6 we saw the highest volume in over a full year with an intraday high with over 20% gain. I believe this is the first positive note in the right direction.1 Year ago the company was looking to do a $600 million dollar Cardiovascular trial that would last years and had no pipeline. Now there are catalysts pouring over the side and the trial will take a fraction of the time at a fraction of the cost.
I believe the current price presents a good opportunity for investors to establish a position and hold through an onslaught of catalysts and take a portion off the table closer to data date. There is considerable upside as we move into 2016 and with the right trading strategy I think Reservlogix is an easy investment choice and a good speculative play for anyone’s portfolio.
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