Relypsa, Inc.
RLYP, a biopharmaceutical company, announced that results from the
pivotal Phase 3 program of the company's lead product candidate, Patiromer for
Oral Suspension (Patiromer FOS), were published today in New England Journal
of Medicine. The program was conducted under Special Protocol Assessment to
evaluate the safety and efficacy of Patiromer FOS for the treatment of
hyperkalemia (HK) in chronic kidney disease (CKD) patients on
renin-angiotensin-aldosterone system (RAAS) inhibitor therapy. Hyperkalemia is
a serious condition defined as abnormally elevated potassium levels in the
blood.
Lead author, Matthew R. Weir, M.D. Professor and Director, Division of
Nephrology, University of Maryland School of Medicine, commented,
"Hyperkalemia remains our primary concern in patients on kidney- and
cardio-protective RAAS therapy. We are pleased to have these exciting results
for Patiromer FOS published in New England Journal of Medicine. The rigor of
the Phase 3 program gives me confidence in the clinical evidence which I
believe sufficiently supports the company's application to gain approval of
Patiromer FOS as a treatment for hyperkalemia."
Last month, the company announced that it had submitted a New Drug Application
to the FDA for Patiromer FOS for the treatment of HK. If approved, Patiromer
FOS is positioned to be the first new treatment for HK in over 50 years and
the first ever studied long-term as a therapy for up to 12 months.
All endpoints were met in the two-part Phase 3 program consisting of a
treatment phase, which was designed to assess the ability of Patiromer FOS to
correct hyperkalemia, and a placebo-controlled randomized maintenance phase
designed to evaluate the effect of continued treatment with Patiromer FOS on
potassium control and ability of patients to continue RAAS inhibitor therapy
compared to placebo. In the treatment phase, among 237 evaluable patients
receiving Patiromer FOS, the mean change in the serum potassium level was
−1.01 mEq/L (P<0.001). At week 4, 76% (95% confidence interval) of the
patients were within the target potassium level (3.8 to < 5.1 mEq/L).
Subsequently, 107 patients were randomly assigned to Patiromer FOS (55
patients) or placebo (52 patients) for the maintenance phase. Of note during
this phase, the Patiromer FOS group had no change in median potassium from
baseline, but in the placebo group, median serum potassium increased
(P<0.001). Further, a recurrence of hyperkalemia (serum potassium level ≥ 5.5
mEq/L) occurred in 60% of the patients in the placebo group as compared with
15% in the Patiromer FOS group through week 8 (P<0.001). In a pre-specified
analysis, 44% patients in the placebo group as compared with 94% in the
Patiromer FOS group were still receiving RAAS inhibitor therapy at the end of
the study. Mild-to-moderate constipation was the most common adverse event
(11% of the patients in the treatment phase and 4% in the Patiromer FOS group
in the maintenance phase). Importantly, there was no evidence of drug-induced
edema or urinary tract infections. The hypokalemia rate over the 4 week
treatment period was low (3%) and no patients in the maintenance phase
experienced hypokalemia. No serious drug-related adverse events were reported
in either the treatment or maintenance phases.
Phase 3 Patiromer FOS Program Background
The two-part Phase 3 clinical program was conducted under an agreed upon
special protocol assessment (SPA) with the U.S. Food and Drug Administration
(FDA). Part A, the treatment phase in which all participants received
Patiromer FOS, was a single-blind, single-arm trial in 243 patients with
hyperkalemia and CKD who were also being treated with RAAS inhibitor
medications. The FDA-agreed upon primary endpoint of Part A under the SPA was
the change in serum potassium from Part A baseline to Part A Week 4. The
secondary endpoint was the proportion of patients with a serum potassium level
in the target range of 3.8 to < 5.1 mEq/L at Part A Week 4.
Part B, the placebo-controlled randomized maintenance phase part of the trial,
was designed to provide additional evidence of the efficacy of Patiromer FOS
in treating hyperkalemia and to assess the need for chronic dosing. Patients
from Part A whose baseline serum potassium level was greater than or equal to
5.5 mEq/L at enrollment and whose serum potassium level was controlled at Part
A Week 4 were eligible for Part B. These patients were then randomized into
two groups; one to continue on Patiromer FOS for an additional eight weeks,
and a second to receive placebo for eight weeks. The primary endpoint for
Part B was the between group difference in the change in serum potassium from
Part B baseline to Week 4 of Part B or to an earlier time point when the
subject first has serum potassium less than 3.8 mEq/L or greater than or equal
to 5.5 mEq/L.
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