Relypsa Inc (NASDAQ:RLYP), a biopharmaceutical company, today announced results from 12 Phase 1 studies in healthy volunteers evaluating potential drug-drug interactions between Veltassa® (patiromer) for oral suspension and 12 drugs that had previously demonstrated binding in in vitro tests. When Veltassa was administered at the same time as the drugs being tested, there was no clinically meaningful reduction in absorption for nine of the 12 drugs. Three drugs showed reduced absorption when they were co-administered with Veltassa, however, when dosing of Veltassa and these drugs was separated by three hours, no reduction in absorption was observed.
“The results from these studies are encouraging as, of the 12 drugs that had previously shown in vitro binding to Veltassa, nine showed no clinically meaningful reduction in absorption when co-administered with Veltassa in people,” said Lance Berman, M.D., chief medical officer of Relypsa. “In addition, when dosing was separated by three hours, there was no impact to absorption of the three drugs that had demonstrated reduced absorption when they were given with Veltassa. We look forward to discussing these data with the FDA and determining next steps.”
Summary of Veltassa Drug-Drug Interaction Program and Results
Veltassa was approved by the U.S. Food and Drug Administration (FDA) on October 21, 2015, for the treatment of hyperkalemia, becoming the first new medicine in more than 50 years for people with elevated blood potassium levels.
The drug-drug interaction program submitted as part of Veltassa’s New Drug Application (NDA) included in vitro drug-drug interaction tests (conducted in test tubes).
As previously announced, in these initial in vitro tests, 14 of the 28 drugs showed no binding with Veltassa, including:
- Antihypertensive medicines (renin angiotensin aldosterone system, or RAAS, inhibitors) – lisinopril, spironolactone, valsartan
- Cholesterol-lowering medicine – atorvastatin
- Anticoagulant and antiplatelet medicines – apixaban, aspirin, rivaroxaban
- Cardiac glycoside – digoxin
- Antidiabetic medicine – glipizide
- Antigout medicine – allopurinol
- Antibiotics – amoxicillin, cephalexin
- Antiepileptic – phenytoin
- Vitamin – riboflavin
Fourteen drugs did show binding in vitro and, of these, 12 were selected for further testing in healthy volunteer studies to assess whether the results seen in vitrotranslated into an effect in people. These randomized, open-label studies were initiated in September 2015 and used a three-way cross-over design. They evaluated the absorption of these 12 drugs when either co-administered with Veltassa or when administered three hours apart from Veltassa. In each study, participants received:
- The test drug alone;
- Veltassa and the test drug administered at the same time; or
- Veltassa administered three hours after the test drug.
For each drug tested, the studies evaluated the concentration in the blood over time (area under the curve or AUC) and the peak blood concentration (Cmax). (Original Source)
Shares of Relypsa closed almost flat today at $19.62. RLYP has a 1-year high of $42.26 and a 1-year low of $10.26. The stock’s 50-day moving average is $25.05 and its 200-day moving average is $23.89.
On the ratings front, Relypsa has been the subject of a number of recent research reports. In a report issued on January 19, Oppenheimer analyst Ling Wang reiterated a Buy rating on RLYP, with a price target of $55, which implies an upside of 182.6% from current levels. Separately, on January 4, BTIG’s Tim Chiang initiated coverage with a Buy rating on the stock and has a price target of $45.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Ling Wang and Tim Chiang have a total average return of -19.9% and 5.6% respectively. Wang has a success rate of 15.6% and is ranked #3586 out of 3608 analysts, while Chiang has a success rate of 54.8% and is ranked #670.
The street is mostly Bullish on RLYP stock. Out of 10 analysts who cover the stock, 9 suggest a Buy rating and one recommends to Sell the stock. The 12-month average price target assigned to the stock is $47.50, which implies an upside of 144.1% from current levels.
Relypsa Inc is a biopharmaceutical company engaged in the development and commercialization of non-absorbed polymeric drugs to treat disorders in the areas of renal, cardiovascular and metabolic diseases.