Health and Healthcare

Relypsa Soars on Positive Phase 1 Results

Chris Lange

Published: January 26, 2016 10:15 am

Last Updated: January 13, 2020 2:35 pm

Relypsa Inc. (NASDAQ: RLYP) rose early in Monday’s session as the result of positive results from its Phase 1 in vivo studies evaluating the interactions between Veltassa (patiromer) and other drugs.

Relypsa announced results from 12 Phase 1 studies in healthy volunteers evaluating potential drug-drug interactions between Veltassa 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.

Previously Veltassa was approved by the U.S. Food and Drug Administration (FDA) in October 2015, for the treatment of hyperkalemia, becoming the first new medicine in over 50 years for people with elevated blood potassium levels.

Lance Berman, M.D., chief medical officer of Relypsa, commented:

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. 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.

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So far in 2016, the stock has vastly underperformed the market, with shares down over 30% year to date. However, over the past 52 weeks shares were down nearly 47%.

Shares of Relypsa were up more than 13% to $22.30 just after the opening bell Tuesday, before retreating. The consensus analyst price target is $47.00, and the 52-week trading range is $10.26 to $42.26.