Tricida seems to have completely fallen off many investor’s radar. I am still following it because I am still under the impression their lead drug candidate works. FDA gave them a CRL complete response of not approving the drug however until they get more direct data that their drug worked. This sent them back to try and gather more information from an ongoing trial they had at the time.
Critical update in Q4 of this year when they expect CKD progression data which they will use to file for drug approval with the FDA.
Aug. 24, 2020-- Tricida, Inc. (Nasdaq: TCDA), a pharmaceutical company focused on the development and commercialization of its drug candidate, veverimer (TRC101), a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with chronic kidney disease (CKD), announced today that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for veverimer on August 21, 2020. The NDA was reviewed under the Accelerated Approval Program.
According to the CRL, 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. FDA also expressed concern as to whether the demonstrated effect size would be reasonably likely to predict clinical benefit. There were no safety, clinical pharmacology/biopharmaceutics, CMC or non-clinical issues identified in the CRL.
Oct. 29, 20200-- Tricida held a Type A meeting with the FDA to discuss their Complete Response Letter. In Tricida’s meeting package before the Type A meeting, the company included a proposal to conduct an interim analysis of serum bicarbonate data from VALOR-CKD in ~500 patients treated for 12 months for purposes of confirming the treatment effect of veverimer observed in the TRCA-301/301E trials and its applicability to the U.S. population and practice of medicine. If accepted by the FDA, Tricida believed this proposal would allow resubmission of the NDA for veverimer within a matter of months. Based on feedback during the Type A meeting, Tricida now believes the FDA will also require evidence of veverimer’s effect on CKD progression from a near-term interim analysis of the VALOR-CKD trial for approval under the Accelerated Approval Program and that the FDA is unlikely to rely solely on serum bicarbonate data for determination of efficacy. The company’s ongoing VALOR-CKD trial was designed to be a confirmatory trial to demonstrate the effect of veverimer on slowing CKD progression following accelerated approval. Based on the primary endpoint and patient population in VALOR-CKD, Tricida does not believe it can provide information on CKD progression from a near-term interim analysis of the VALOR-CKD trial without compromising the integrity of the ongoing trial.
Dec. 08, 2020–Tricida has revised the protocol for its VALOR-CKD outcome trial. The VALOR-CKD trial evaluates the effect of treating metabolic acidosis with veverimer on the clinical endpoint of slowing of CKD progression. The trial protocol previously had an adaptive design and included an unblinded interim analysis for sample size re-estimation. The revised protocol has a group sequential design, no interim analysis for sample size adjustment, and unblinded interim analyses for early stopping for efficacy after 150 primary endpoint events (anticipated in the second half of 2021) and 250 primary endpoint events (anticipated in mid-2022) have accrued. A primary endpoint event is defined as renal death, end-stage renal disease (ESRD) or = 40% reduction in estimated glomerular filtration rate (eGFR) (DD40). The interim analyses will be conducted by an independent unblinded Interim Analysis Committee, and the trial will remain blinded unless it is stopped early for efficacy. If this trial is successful, Tricida intends for it to serve as the confirmatory trial for accelerated approval or form the basis for traditional approval of veverimer. Patent extended until 2038.
May 19, 2022–Tricida Announces Administrative Stop of the VALOR-CKD Trial. Expects to Announce Top-Line Results Early in the Fourth Quarter of 2022. As of May 18, 2022, the average treatment duration of the 1480 subjects randomized in the trial was approximately 25 months, and the trial had accrued 237 subjects with positively adjudicated primary endpoint events, defined as renal death, end-stage renal disease (ESRD), or greater than or equal to 40% reduction in estimated glomerular filtration rate (eGFR). The trial will continue to accrue primary endpoint events as clinical trial subjects complete their participation in the study which, for the last subject, is currently projected to occur in the third quarter of 2022.
“We have previously received feedback from the FDA on the administrative stop and believe that stopping the VALOR-CKD trial early will allow us to obtain interpretable data from the trial. We expect this data will allow us to evaluate how treatment with veverimer impacts slowing of CKD progression in patients with metabolic acidosis and CKD,” said Gerrit Klaerner, Ph.D., Tricida’s Chief Executive Officer and President.
Per their latest conference call:
With regards to timing overall towards potential commercial launch, presuming we have the announcement of the VALOR study early in Q4, we would anticipate filing or resubmitting the NDA in Q2 of ‘23 and have a potential PDUFA date in Q4 of 2023. That’s a 6-month review for a resubmission. And then roughly speaking, we would have a launch in Q1 of 2024. So presuming positive data on VALOR-CKD, we will put those plans into motion later this year.
With regards to capital and runway, as I discussed earlier, we have sufficient capital based on our current plans through the first quarter of next year into the early part of Q2 of 2023. We also have in place warrants that were related to our direct equity investment at the end of last year. So, we have 7 million warrants outstanding with an exercise price of 11 and those warrants would expire 6 weeks after the announcement of VALOR-CKD data if, in fact, our stock price trades above $15 per share with a certain volume requirement. But assuming a good reaction to the VALOR positive data, we would have the opportunity to bring in $77 million through the exercise of those warrants, which would take us into late 2023 with regards to capital. And I think with regards to any further additions to capital, we will address that after we receive and announce the VALOR-CKD data.