Shares of Tricida (NASDAQ: TCDA), a pre-commercial biopharmaceutical company, are soaring after the release of clinical trial results and fourth-quarter earnings. Investors increasingly excited about TRC101 for the treatment of metabolic acidosis have driven the stock 46.8% higher as of 3:13 p.m. EDT on Thursday.
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Earlier this month, The Lancet published results from a phase 3 trial with Tricida's lead candidate, TRC101, a polymer that binds to hydrochloric acid so it can be excreted. Investors are pushing the stock higher today because a blinded, placebo-controlled 40-week extension study to assess safety produced some surprising results.
Patients with chronic kidney disease often lose the ability to excrete the acid that digests their food, and that leads to further kidney damage and makes bones brittle. We already knew that signs of metabolic acidosis fell for an impressive 59% of patients who swallowed glasses of water containing TRC101 compared to just 22% of patients in the placebo group. What we didn't know was how this would affect outcomes.
The 40-week extension data didn't just prove TRC101 is as safe as a placebo. It looks like it makes a big difference for patients. The incidence of serious adverse events was 272% higher in the placebo group.
Moreover, 10.8% of the placebo group experienced a 50% or worse drop in kidney function, and four died. Only 4% of patients treated with TRC101 experienced a 50% drop, and there weren't any deaths in the active group.
This was supposed to be a safety study tacked on to the phase 3 trial that already succeeded, but didn't raise any eyebrows. With evidence of significantly better long-term outcomes, though, TRC101 could become a standard treatment for metabolic acidosis.
In the U.S. alone, there are around 3 million people living with chronic kidney disease that's getting worse due to metabolic acidosis. That gives TRC101 blockbuster potential if it earns approval.
Tricida plans to submit a new drug application for TRC101 in the second half of 2019.
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