FDA Issues CRL for Tricida's Metabolic Acidosis in CKD Treatment
Shares of Tricida fell more than 23% late Monday and continued to fall in premarket trading this morning after the company announced the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter for its experimental chronic kidney disease treatment, veverimer.
South San Francisco-based Tricida submitted its New Drug Application for veverimer (TRC101), a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with chronic kidney disease (CKD), in August 2019. Data for the NDA was supported by data from the Phase III TRCA-301E study in 196 CKD patients with metabolic acidosis. The trial met its primary and secondary endpoints and the data revealed that patients treated with TRC101 showed a significant reduction in all-cause mortality and progression of CKD. The NDA was reviewed under the Accelerated Approval Program. There are no FDA-approved treatments for chronic metabolic acidosis, a condition commonly caused by CKD that is believed to accelerate the progression of kidney deterioration. It is estimated to pose a health risk to approximately three million patients with CKD in the United States.
Tricida said the FDA is seeking additional data beyond the TRCA-301 and TRCA-301E trials regarding the magnitude and durability of the treatment effect of veverimer on the surrogate marker of serum bicarbonate and the applicability of the treatment effect to the U.S. population. The FDA also expressed concern as to whether the demonstrated effect size would be reasonably likely to predict clinical benefit, Tricida said in its announcement. There were no safety or clinical issues identified in the Complete Response Letter.
While the FDA said it is willing to meet with Tricida to discuss options for potential approval, the company said the regulatory agency could require another clinical trial. Tricida plans to request a Type A meeting with the FDA, which is expected to take place in the fourth quarter of this year. Following that meeting, the company will provide an update on next steps and estimated timing of a potential resubmission of the NDA.
“We have collaborated with the FDA on the Accelerated Approval Program for veverimer and while we are disappointed to receive this CRL, we are pleased that the FDA has provided helpful, specific comments and indicated their willingness to continue to work with us to pursue approval of veverimer,” Gerrit Klaerner, Tricida’s chief executive officer said in a statement. “We remain confident in the fundamentals of, and unmet medical need for, veverimer and we continue to conduct our confirmatory trial, VALOR-CKD.”
If another trial is necessary, Tricida said it has the financial resources to weather the storm. As of the end of the second quarter of this year, the company had cash, cash equivalents and investments of $437 million. Tricida said it is positioned to fund operations into early 2022.