Relypsa, Inc., a biopharmaceutical company developing non-absorbed polymeric drugs, today announced the completion of a Series B financing totaling $70 million. OrbiMed Advisors, LLC, led the financing with participation from existing Relypsa investors New Leaf Venture Partners, 5AM Ventures, Delphi Ventures, Sprout Group and Mediphase Venture Partners.
“Founded three years ago, the Relypsa team has demonstrated that non-absorbed drugs with meaningful serum endpoints can be rapidly developed from preclinical stage to end of Phase 2, far surpassing our expectations”
Proceeds from the financing will support the advancement of Relypsa's lead compound, RLY5016, through pivotal clinical studies. RLY5016 is a high capacity non-absorbed oral potassium binder being developed for the chronic and acute management of hyperkalemia, which is most prevalent in patients that suffer from renal impairment, hypertension, diabetes and heart failure. Many of these patients are indicated to be on multiple, life-saving RAAS blocking drugs. However, these therapies are associated with an increased incidence of hyperkalemia as they impair the kidney's ability to excrete potassium. Relypsa has completed several clinical trials of RLY5016, including the PEARL-HF Phase 2 clinical trial, a multi-center, randomized, placebo-controlled study that assessed the efficacy, safety and tolerability of RLY5016 for the prevention of hyperkalemia in heart failure patients. A multi-center, open-label study to explore titration of RLY5016 is currently underway and is intended to inform pivotal study design.
"We are gratified to have completed this financing and to add OrbiMed to our list of top-tier investors," said Gerrit Klaerner, Ph.D., President of Relypsa. "Our balance sheet enables us to translate our strong RLY5016 clinical data into an efficient pivotal program that we plan to initiate in the first half of 2011."
In conjunction with the financing, Jonathan T. Silverstein, J.D., General Partner of OrbiMed will join the company's Board of Directors. "RLY5016 represents a unique late-stage asset with a potential market, clinical and regulatory profile that is well suited for us to fund to NDA submission and beyond," said Mr. Silverstein. "We have been impressed by Relypsa's achievements to date in the development of this compound, and we are excited to support future efforts."
Furthermore, Thomas J. Schuetz, M.D., Ph.D., will join the company's Board of Directors and Jay P. Shepard will step down, bringing the total number of Relypsa Board members to seven.
Prior investors participating in the Series B and existing Board members are Scott M. Rocklage, Ph.D., Managing Partner of 5AM Ventures and executive Chairman of Relypsa, Deepa Pakianathan, Ph.D., General Partner at Delphi Ventures and Vijay Lathi, Managing Partner, New Leaf Venture Partners.
"Founded three years ago, the Relypsa team has demonstrated that non-absorbed drugs with meaningful serum endpoints can be rapidly developed from preclinical stage to end of Phase 2, far surpassing our expectations," said Mr. Lathi. "On behalf of Relypsa's founding investors, we are delighted to participate in this round to continue building a company around a technology platform and a late stage asset that represents a significant opportunity in the cardio-renal area."