SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Tricida, Inc., a privately-held, clinical stage, biopharmaceutical company focused on the discovery and development of non-absorbed therapies, today announced topline results from its Phase 1/2 clinical study for its lead investigational drug candidate, TRC101, in 135 patients with chronic kidney disease (CKD) and metabolic acidosis. TRC101 represents a first-in-class approach to the treatment of metabolic acidosis, a common complication of CKD that can result in increased mortality, accelerated progression of kidney disease, progressive muscle breakdown and exacerbation of bone disease. TRC101 is a new chemical entity discovered and under development by Tricida. The non-absorbed, orally-administered polymer is designed to remove acid from the body with high capacity and specificity, with the objective to treat chronic metabolic acidosis associated with CKD as measured by an increase of patients’ serum bicarbonate levels.
The double-blind, placebo-controlled study (TRCA-101, NCT02809183) evaluated the safety and efficacy of TRC101. All primary and secondary endpoints were met. Each of the three doses (3, 6 and 9 g) and both dosing regimens (once-daily and twice-daily) of TRC101 increased serum bicarbonate from baseline to the end of treatment (Day 15) in a highly statistically significant (p<0.0001) and clinically meaningful manner with the majority of the patients on TRC101 seeing greater than 3 mEq/L increases from baseline within two weeks. TRC101 was well-tolerated. All patients completed the study and there were no serious or severe adverse events. The majority of the treatment-emergent adverse events in the TRC101-treated subjects were mild/moderate gastrointestinal adverse events (e.g., diarrhea and constipation), which is consistent with a non-absorbed drug acting primarily within the gastrointestinal tract. No dose response was observed for any adverse event.
Based on these results, Tricida plans to initiate a Phase 3 program to evaluate the safety and efficacy of TRC101 as a potential treatment for chronic metabolic acidosis associated with CKD.
“I am very proud of the Tricida team who discovered and led the early development of TRC101. The clinical proof-of-concept study far exceeded our expectations in terms of rapid onset of action and the magnitude of increase in serum bicarbonate,” said Dr. Gerrit Klaerner, Ph.D., Tricida’s CEO, President, and Board Member.
“Based on these results, TRC101 aims to address one of the major unmet medical needs in kidney disease with currently no approved drugs. Chronic metabolic acidosis is at the center of a vicious cycle: buildup of acid is caused by kidney disease and at the same time induces further renal deterioration,” said Dr. Klaus Veitinger, M.D., Ph.D., Chairman of the Tricida Board and Venture Partner at OrbiMed.
The data will be submitted for consideration in a peer-reviewed journal.
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.
For more information, visit www.tricida.com.