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Relypsa Initiates Phase 2b Clinical
Trial of RLY5016 for the Prevention of Hyperkalemia in Heart
Failure Patients
PEARL-HF Phase 2b Trial Follows Three Successful Phase 1 and
2a Trials
Santa Clara, CA, October 7, 2009 — Relypsa, Inc., today
announced the initiation of patient enrollment in the PEARL-HF
study, a Phase 2b clinical trial of the company’s lead compound,
RLY5016. A novel potassium binder designed for chronic use,
RLY5016 is being evaluated in the prevention and treatment of
hyperkalemia, for which there are no current satisfactory
treatments.
Hyperkalemia is a condition characterized by elevated serum
potassium levels, which can lead to cardiac arrhythmia and
sudden death. Heart failure patients are at particular risk for
developing hyperkalemia, especially those patients with
underlying chronic kidney disease treated with Renin-Angiotensin-Aldosterone-System
(RAAS) inhibitors. RAAS inhibition in such patients provides a
life-saving therapy, but has the undesirable side effect of
increasing serum potassium.
The PEARL-HF Phase 2b clinical trial is a multi-center,
randomized, placebo-controlled study designed to assess the
efficacy, safety and tolerability of RLY5016 for the prevention
of hyperkalemia in heart failure patients. The study is being
conducted at clinical sites worldwide and patient enrollment is
underway.
The Phase 2b clinical trial follows the successful completion of
three clinical trials of RLY5016, including two Phase 1 trials
and a Phase 2a trial. RLY5016 was well-tolerated in these
studies. In healthy volunteers, RLY5016 demonstrated
dose-related pharmacological effects. In a Phase 2a clinical
trial of hemodialysis patients with hyperkalemia, RLY5016
lowered serum potassium, achieving proof-of-concept.
“We are pleased to advance our lead compound RLY5016 into Phase
2b clinical testing, following very encouraging tolerability and
efficacy results observed in Phase 1 and Phase 2a clinical
trials,” said Detlef Albrecht, M.D., Chief Medical Officer and
Senior Vice President, Drug Development of Relypsa. “RLY5016
holds great promise in preventing and treating hyperkalemia, and
thereby enhancing the use of life-saving drugs for heart failure
patients. To date, we have been pleased by the interest received
from clinical investigators and the positive enrollment trends
observed in the first portion of the trial. We look forward to
reporting interim results from the PEARL-HF Phase 2b clinical
trial in the first quarter of 2010.”
Relypsa’s Chief Operating Officer, Gerrit Klaerner, Ph.D.
commented, “We are proud to achieve this milestone in a capital-
and time-efficient manner. Since Relypsa’s inception less than
two years ago, we have made remarkable progress by advancing a
preclinical asset through human proof-of-concept. We anticipate
interim results from the Phase 2b trial will help us to position
RLY5016 as an essential tool for cardiologists and nephrologists
to optimize the use of cardiovascular agents with proven
outcomes. The practice of deploying therapies that address
toxicities and side effects of life-saving treatments is well
established in oncology, but this will be a first in the
cardiovascular field. Our goal is to establish Relypsa as one of
the leading companies focused on patients with chronic
cardio-renal diseases.”
About Relypsa, Inc.
Relypsa, Inc. is a privately-held, development-stage
biopharmaceutical company leading the discovery and development
of novel non-absorbed polymeric drugs for important applications
in cardiovascular and renal disease. Relypsa's lead product
candidate is RLY5016, a non-absorbed potassium binder for the
management of hyperkalemia. Relypsa is dedicated to the
discovery of additional product candidates through use of its
proprietary polymer platform. Relypsa has raised a total of $43
million in a Series A round from leading venture capital firms,
including 5AM Ventures, Amgen, Delphi Ventures, Mediphase
Ventures, NLV Partners. For additional information, please see
the Relypsa website at
www.relypsa.com.
Contact
Reypsa, Inc.
Gerrit Klaerner, Ph.D
SVP, COO
PR "at" relypsa.com
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