Proceeds will be used to complete the ongoing pivotal TRCA-301 Phase 3 clinical trial of TRC101.
Tricida reported that it had closed an oversubscribed Series D financing worth $57.5 million. Existing investors OrbiMed, Longitude Capital, Sibling Capital Ventures, Limulus Venture Partner and Vivo Capital were joined by Wellington Management Company, Venrock Healthcare Capital Partners and Cormorant Asset Management. The round brings the company’s total capital raised to $153.5 million.
Tricida focuses on discovering and developing non-absorbed therapies. Its lead compound is TRC101, which is a first-in-class approach to treating metabolic acidosis, a common complication of chronic kidney disease (CKD).
The funds will be used to complete the ongoing pivotal Phase III clinical trial of TRC101.
“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,Tricida’s chief financial officer, in a statement. “Tricida is well-positioned to meet its future capital needs.”
Yesterday, Tricida published the full results from the Phase I/II trial of TRC101 in the Clinical Journal of the American Society of Nephrology. It was also presented at the American Society of Nephrology (ASN) Kidney Week 2017 in New Orleans, Louisiana on Nov. 4.
Gerrit Klaerner, Tricida’s chief executive officer and president said in a statement, “We greatly appreciate the critical leadership of Dr. David Bushinsky at the University of Rochester School of Medicine, who served as the lead investigator for the TRCA-101 trial. Based upon the results of our TRC101 Phase I/II study, we have initiated our pivotal Phase III study, TRCA-301, and plan to report topline results during the second quarter of 2018.”
In the study, 135 patients with CKD and metabolic acidosis on a controlled diet were given either a placebo or one of four dosing regimens of TRC101 for 14 days, then followed for seven to 14 days. The company noted, “All TRC101 regimens increased serum bicarbonate from baseline to the end of treatment in a statistically significant and clinically meaningful manner, with most of the patients on TRC101 seeing greater than 3 mEq/L increases from baseline within two weeks. Further, all TRC101 treatment groups showed a significant increase in serum bicarbonate within 72 hours of the first dose.”
All side effects were mild or moderate.
The Phase III trial is a randomized, double-blind, placebo-controlled, multicenter trial to evaluate the efficacy and safety of TRC101 in patients with CKD and metabolic acidosis. It will enroll about 210 patients at 54 sites and follow a 12-week, once-daily course of treatment followed by a blinded, placebo-controlled 400-week extension trial.
About one in seven adults in the U.S. has CKD. Patients with CKD often have a reduced ability to excrete acid created by intrinsic and dietary metabolism, mostly protein, which results in metabolic acidosis. This then causes lower blood pH and decreased blood bicarbonate levels. This can lead to early kidney disease, progressive muscle breakdown, worsening bone diseases, and an increased mortality risk. There are no treatments for chronic metabolic acidosis approved by the U.S. Food and Drug Administration (FDA).
Tricida plans, depending on the results of the Phase III trial, to submit a New Drug Application (NDA) to the FDA under its accelerated approval pathway. It hopes to have topline results in the second quarter of 2018 and conduct a confirmatory post-marketing study after completing the Phase III trial.
