After Tricida Inc. (NASDAQ: TCDA) announced results from its chronic kidney disease (CKD) trial, its shares jumped on Thursday. Specifically, the results come from TRCA-301 (veverimer), in 196 CKD patients with metabolic acidosis.
Also, Proteon Therapeutics released results from its CKD study and the stock was absolutely crushed.
Some quick background: metabolic acidosis is a chronic condition commonly caused by CKD that is believed to accelerate the progression of the disease, increase the risk of muscle wasting and cause the loss of bone density.
Results from the TRCA-301 and TRCA-301E trials will support the TRC101 New Drug Application (NDA) submission planned for the second half of 2019.
Based on the initial topline data analyses, the TRCA-301E trial met its primary and all secondary endpoints. The primary endpoint of the TRCA-301E trial was the assessment of the long-term safety profile of TRC101 versus placebo.
The secondary endpoints of the TRCA-301E trial assessed the durability of effect of TRC101, both on blood bicarbonate levels and on measures of physical function, over the 52-week treatment period for those subjects who participated in the TRCA-301E trial. All were met with high statistical significance.
The only adverse event with a between-group frequency difference of >5% was headache, which was more common in the placebo group. Gastrointestinal adverse events occurred in 21.4% of subjects in the TRC101 group and in 25.9% of subjects in the placebo group.
Donald E. Wesson, M.D., MBA, professor of Medicine at Texas A&M Health Sciences Center College of Medicine in Dallas and the lead investigator for the trial, commented:
This trial provides evidence of long-term safety and tolerability of TRC101 and that the sustained increase in blood bicarbonate led to improvements in multiple clinical outcomes that matter to both patients and physicians. Furthermore, the outcomes observed in the placebo arm of this well-controlled, multi-center trial reiterate the importance to diagnose and treat metabolic acidosis in patients with CKD.
Shares of Tricida were last seen up about 36% at $33.02, in a 52-week range of $19.43 to $40.10. The consensus price target is $50.00.