SOUTH SAN FRANCISCO, CA, Phase 3 stage biopharmaceutical company focused on the discovery and development of non-absorbed oral drug therapies, has closed an oversubscribed $57.5M Series D.
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Tricida, Inc., a Phase 3 stage biopharmaceutical company focused on the discovery and development of non-absorbed oral drug therapies, today announced the closing of an oversubscribed $57.5 million Series D financing, bringing the company's total capital raised to-date to $153.3 million. Wellington Management Company LLP, Venrock Healthcare Capital Partners and Cormorant Asset Management joined existing investors OrbiMed, Longitude Capital, Sibling Capital Ventures, Limulus Venture Partners and Vivo Capital in the round.
Proceeds will be used to complete the ongoing pivotal TRCA-301 Phase 3 clinical trial of TRC101, Tricida's first-in-class investigational drug candidate for the treatment of chronic metabolic acidosis in patients with chronic kidney disease (CKD).
"With the additional capital raised in our Series D financing, Tricida now has the resources to complete our pivotal Phase 3 study of TRC101, which has the potential to address a significant medical need for patients suffering from metabolic acidosis associated with chronic kidney disease," said Gerrit Klaerner, Ph.D., Chief Executive Officer of Tricida.
"We are exceptionally pleased to have completed this financing with a majority of the capital coming from a new group of leading healthcare blue-chip investors as well as significant participation from our excellent group of existing investors," said Geoff Parker, Chief Financial Officer of Tricida. "Tricida is well-positioned to meet its future capital needs," noted Parker.
If successful, the TRCA-301 Phase 3 clinical trial will serve as the pivotal trial for the submission of a U.S. New Drug Application for TRC101 under the FDA's accelerated approval pathway. Tricida plans to report topline results from this clinical trial in the second quarter of 2018 and to conduct a confirmatory post-marketing study of TRC101 following completion of the TRCA-301 Phase 3 study. The results of Tricida's successful Phase 1/2 study were recently presented at the American Society of Nephrology's (ASN) Annual Kidney Week 2017 and have also been published in the Clinical Journal of the American Society of Nephrology (CJASN) in an article, entitled "Randomized, Controlled Trial of TRC101 to Increase Serum Bicarbonate in Patients with CKD," (https://doi.org/10.2215/CJN.07300717).
TRC101, a new chemical entity discovered by Tricida, is being developed as a first-in-class, orally administered, counterion-free, insoluble, non-absorbed polymeric drug for the treatment of metabolic acidosis in patients with chronic kidney disease (CKD).
About the TRCA-301 Study
TRCA-301 is a randomized, double-blind, placebo-controlled, multicenter trial that is evaluating the efficacy and safety of TRC101 in subjects with CKD and metabolic acidosis. The trial is expected to enroll approximately 210 subjects at 54 sites and is evaluating a 12-week, once-a-day course of treatment with TRC101 compared to placebo, followed by a blinded, placebo-controlled 40-week extension study. The key efficacy endpoints of Study TRCA-301 are based on the change in blood bicarbonate from baseline to the end of treatment.
About CKD and Metabolic Acidosis
In the United States, approximately 1 in 7 adults has CKD, a progressive and often-times debilitating disease. Patients with CKD may have a reduced ability to excrete acid generated by intrinsic and dietary metabolism, especially protein, resulting in metabolic acidosis. Metabolic acidosis results in lower blood pH and decreased blood bicarbonate levels. Chronic metabolic acidosis can lead to accelerated progression of kidney disease, progressive muscle breakdown, exacerbation of bone disease, and an increased rate of mortality. In the United States, chronic metabolic acidosis affects a significant percentage of CKD patients resulting in approximately 3 million to 4 million adults with chronic metabolic acidosis. There are no FDA-approved treatments for chronic metabolic acidosis.
Tricida, Inc. is a privately-held, clinical stage, biopharmaceutical company focused on the discovery and development of non-absorbed oral drug therapies. Tricida's lead investigational drug candidate, TRC101, represents a first-in-class approach for the treatment of metabolic acidosis, a common complication of CKD that can result in accelerated progression of kidney disease, progressive muscle breakdown, exacerbation of bone disease, and an increased rate of mortality. In January 2016, the FDA accepted Tricida's Investigational New Drug (IND) application for TRC101. The company has since successfully completed a Phase 1/2 double-blind, placebo-controlled study in which the safety, tolerability and efficacy of TRC101 were evaluated in subjects with CKD and low serum bicarbonate. Tricida is currently conducting a Phase 3 study of TRC101 for the treatment of metabolic acidosis associated with CKD designed to serve the basis for the submission of a U.S. New Drug Application for TRC101 under the FDA's accelerated approval pathway.
Cautionary Note on Forward-Looking Statements
This press release includes forward-looking statements, including, for example, potential therapeutic capabilities, potential medical need and market size, and our expected timeline of development. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. For example, many drug candidates entering Phase 3 trials do not become approved drugs. The forward-looking statements contained in this press release reflect Tricida's current views with respect to future events, and Tricida does not undertake and specifically disclaims any obligation to update any forward-looking statements.