Hours after filing $150M IPO, Tricida shares positive PhIII trial results on CKD drug
South San Francisco drugmaker Tricida signaled plans late Monday to raise $150 million in an IPO, stockpiling cash to fuel the company’s NDA filing and commercial launch of its late-stage chronic kidney disease drug. Then hours after its filing, the company announced positive Phase III data, with its drug meeting all primary and secondary endpoints.
The company’s lead drug is TRC101, a novel polymer that’s served up orally as a suspension in water to treat metabolic acidosis in CKD patients. It’s designed to bind to hydrochloric acid in the GI tract, then remove the acid via excretion — thereby decreasing the amount of acid in the body and boosting blood bicarbonate.
The Phase III trial was double-blind, randomized, and placebo-controlled, testing the drug in 217 CKD patients with metabolic acidosis. Based on initial topline analyses, the trial met its primary and secondary endpoints in a “highly statistically significant manner” (p<0.0001 for all endpoints). After 12 weeks on the drug, 59.2% of patients saw an increase in blood bicarbonate of a least 4 milliequivalents per liter compared with 22.5% of the placebo group.
According to Tricida’s S-1 filing noting their IPO plans, the company will use the proceeds to pay for its NDA, manufacturing, and the commercial launch of the drug. The company will also use the funds for interest payments to its lender Hercules Capital.
Tricida, founded in 2013, plans to list on the Nasdaq under the stock symbol $TCDA. The company is led by founder, CEO, and president Gerrit Klaerner, the guy who founded Relypsa — the company snatched up by Galenica back in 2016 for $1.5 billion.