Opko Health Posts Positive Phase 3 Results For Its Rayaldee Drug

On August 11, 2014 OPKO Health (OPK) had released its results for a phase 3 trial utilizing a drug known as Rayaldee to treat patients with chronic kidney disease that are insufficient in Vitamin D (Vitamin D insufficiency). Vitamin D insufficiency means that the person's body is not able to easily convert the Vitamin D mineral to the body which results in a loss of vital nutrients. Vitamin D in the body is essential for renal health, immune system health, and cardiovascular health. Vitamin D insufficiency is even worse in patients with chronic kidney disease, because the disease makes it a lot more difficult for the patients to be able to convert Vitamin D into their bodies properly.

Opko Health posted positive phase 3 results for its Rayaldee drug compound by improving Vitamin D levels in patients with secondary hyperparathyroidism -- SHPT --  which stems from stage 3 and stage 4 chronic kidney disease. The results can be summed up by the Vice President of Research and Development Joel Z Milnick of Opko's renal health division:

"Top-line data from this study demonstrate that Rayaldee effectively controls secondary hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease by correcting vitamin D insufficiency"

The phase 3 results were able to help patients achieve the ability to properly elevate the patients' vitamin D levels to appropriate measures. The phase 3 trial had enrolled 219 patients which were all lacking Vitamin D . Some patients were given Ryaldee and other patients were given a placebo compound. By the end of the trial 97% of the patients had corrected their Vitamin D insufficiency by taking Rayaldee, which shows the market potential for the drug when it makes it to market. The Rayaldee compound was able to achieve great safety measures and also achieve the primary endpoint of the study. The primary endpoint of the study was something known as "responder analysis". This means that at least 30% of the patients needed to exhibit a decrease of the plasma parathyroid hormone -- effect of chronic kidney disease. Two positives came from the primary endpoint of the study. For starters the response rate of the primary endpoint achieved clinical efficacy of p < 0.001 . This p value is a measure of clinical success, and anything under p < .01 means that the trial achieved its primary endpoint.

The success of this treatment is great because current treatment options have their own problems. Vitamin D offered over the counter are ineffective in helping these chronic kidney disease patients with their hyperparathyroidism at all. Vitamin D Hormones actually do more harm than good because they offer Vitamin D at extremely abundant levels. That means they bring the Vitamin D level to a higher level than is needed in the body -- basically way too much Vitamin D .  Investors though will still be happy to know that there are further catalysts coming for Opko's Rayaldee drug before the end of 2014. First the company expects to announce additional data from a similar phase 3 trial using Rayaldee for the same indication of Vitamin D insufficiency in Chronic Kidney disease. These additional phase 3 results are due out sometime in September 2014. Another catalyst is that Opko expects t file an NDA for Rayldee to the FDA before the end of 2014 -- this means that the company is seeking approval for Rayaldee.

We believe that Opko Health is a great long term play because it has a nice pipeline of drug compounds that can create future value for shareholders. We also like the fact that the CEO is a man known as Dr. Phillip Frost who is famous for acquiring biotechnology stocks that come in value in the future. Dr. Phillip Frost knows true value when he sees it, and we feel Opko will do well in the long term. Dr. Phillip Frost had even invested in a biotechnology company known as Rxi Pharmaceuticals (RXII) when it was trading back on the OTC. Rxi Pharmaceuticals now trades on the NASDAQ and is expected to release phase 2 results of a trial in a few weeks, using RXI-109  to target hypertrophic scars -- raised scars that are difficult to treat and grow back instantly. Dr. Frost had made a private placement deal buying $16.4 million dollars worth of shares during the deal with Rxi's CEO Dr. Geert Cauwenbergh back in 2013. We believe that Opko will continue to rise as investors realize the true value of the company.

 

Disclosure: no positions in any stocks mentioned

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