Relypsa, Inc. (NASDAQ:RLYP), a biopharmaceutical company, today announced that results of a pre-specified exploratory analysis of the Phase 3 OPAL-HK trial of Veltassa® (patiromer) for oral suspension were published online by Kidney International, the journal of the International Society of Nephrology. The previously published OPAL-HK study evaluated Veltassa in patients with hyperkalemia (elevated blood potassium levels) and chronic kidney disease (CKD) who were taking renin angiotensin aldosterone system (RAAS) inhibitors. Results of this newly published analysis found that patients taking Veltassa in the study had significant decreases in systolic and diastolic blood pressure and reduced levels of aldosterone in the blood. Aldosterone is a hormone that plays an important role in the body’s regulation of blood pressure and blood potassium levels.
“High aldosterone levels can be problematic for patients as they are associated with worsening of cardiovascular and kidney disease and are associated with increases in blood pressure,” said Matthew R. Weir, M.D., lead author of the Kidney International paper, lead investigator of the OPAL-HK trial, and professor and director of the Division of Nephrology at the University of Maryland School of Medicine in Baltimore. “This analysis suggests that patiromer’s potassium lowering effects may be associated with reductions in blood pressure and aldosterone production. These findings could be important for people with CKD and are worth evaluating further.”
Results of Pre-Specified Analysis of OPAL-HK Trial
The main results of the pivotal Phase 3 OPAL-HK study of Veltassa were previously published in the New England Journal of Medicine.1
This pre-specified exploratory analysis examined the effect of Veltassa on systolic and diastolic blood pressure, as well as various cardiovascular and renal biomarkers including: levels of aldosterone in the blood, plasma renin activity (PRA; a measure of the activity of the plasma enzyme, renin, which regulates angiotensin and aldosterone production), and urinary albumin-to-creatinine ratio (UACR; a test used to diagnose and monitor kidney disease by evaluating how much albumin is excreted in the urine). Results of this analysis are summarized below.
During the initial four-week treatment phase, when all patients were taking Veltassa:
- Systolic blood pressure significantly decreased by -5.64 mmHg and diastolic blood pressure significantly decreased by -3.84 mmHg (p < 0.0001 for both).
- Mean levels of aldosterone in the blood significantly decreased by -1.99 ng/dL (p=0.0001).
- PRA did not change.
- UACR significantly decreased by -203.7 mg/g (p=0.0003).
Following the initial treatment phase, during the eight-week randomized placebo-controlled withdrawal phase:
- Mean systolic blood pressure and diastolic blood pressure were significantly reduced in patients taking Veltassa (-6.70 mmHg; p < 0.0001 and -2.15 mmHg; p≤0.05, respectively); in patients taking placebo, mean changes in systolic blood pressure and diastolic blood pressure were not significant (-1.21 mmHg and +1.72 mmHg, respectively).
- Mean aldosterone levels were maintained at baseline levels in patients taking Veltassa (+0.23 ng/dL); in patients taking placebo, levels significantly increased (+2.78 ng/dL; p≤0.03).
- There were no statistically significant changes in PRA in patients taking Veltassa; PRA significantly decreased in patients taking placebo (-3.90 µg/L/hr; p=0.0067).
- By the end of the withdrawal phase, 94 percent of patients in the Veltassa group were still receiving their RAAS inhibitor medication, compared with 44 percent of patients in the placebo group. Among patients in the placebo group, 52 percent discontinued RAAS inhibitor therapy because their hyperkalemia was insufficiently controlled while taking these medications. (Original Source)
Shares of Relypsa closed today at $15.89, down $1.54 or -8.84%. RLYP has a 1-year high of $35.97 and a 1-year low of $10.26. The stock’s 50-day moving average is $17.17 and its 200-day moving average is $18.45.
On the ratings front, Relypsa has been the subject of a number of recent research reports. In a report issued on June 16, Mizuho analyst Irina Rivkind Koffler reiterated a Hold rating on RLYP, with a price target of $20, which implies an upside of 15.5% from current levels. Separately, on the same day, BTIG’s Tim Chiang maintained a Buy rating on the stock and has a price target of $35.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Irina Rivkind Koffler and Tim Chiang have a total average return of 24.4% and 1.5% respectively. Koffler has a success rate of 54.2% and is ranked #11 out of 3980 analysts, while Chiang has a success rate of 47.5% and is ranked #1515.
The street is mostly Bullish on RLYP stock. Out of 11 analysts who cover the stock, 9 suggest a Buy rating , one suggests a Sell and one recommends to Hold the stock. The 12-month average price target assigned to the stock is $27.20, which represents a potential upside of 57.0% from where the stock is currently trading.
Relypsa, Inc. operates as a bio-pharmaceutical company focused on the development and commercialization of non-absorbed polymeric drugs to treat disorders in the areas of renal, cardiovascular and metabolic diseases. Its products include patiromer, a non-absorbed for the treatment of hyperkalemia and RLY6002, polymer drug discovery technology.