Pharmaceutical Business review

Tricida announces closing of $57.5m series D financing

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.

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).

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.