Tricida has filed to raise $150 million to bring a chronic kidney disease drug to market. Proceeds from the planned IPO will set Tricida up to file for FDA approval of TRC101 and start building up the 80- to 100-person sales team it wants to commercialize the drug.
TRC101 is a polymer designed to selectively bind to hydrochloric acid in the gastrointestinal tract and take it out of the body in feces. In doing so, Tricida thinks TRC101 can decrease acid levels and boost the amount of blood bicarbonate. By triggering the changes, TRC101 could treat metabolic acidosis, a condition characterized by the accumulation of acid that contributes to the progression of chronic kidney disease.
Tricida has phase 3 data suggesting aspects of the idea work in practice. In a 217-patient phase 3, blood bicarbonate levels increased by a certain amount or normalized in 59.2% of participants who received TRC101, as compared to 22.5% of people in the placebo cohort. That resulted in the trial hitting its primary endpoint. The study also aced a secondary endpoint that looked at change in blood bicarbonate from baseline.
Armed with the data, Tricida plans to file for FDA approval under the accelerated approval program in the second half of next year. The IPO haul will equip Tricida to file for approval while manufacturing TRC101 and building out its commercial infrastructure ahead of the anticipated U.S. launch.
While Tricida has data from a phase 3 trial, its ability to secure approval on the strength of the results depends on other factors. The FDA has told Tricida it needs to almost finish enrolling a postmarket trial before filing its NDA. Tricida thinks a 1,400- to 1,600-patient study will be sufficient to meet the FDA’s request, but the final sample size is still subject to discussions with the agency.
Tricida sees progress in those discussions and enrollment in the trial leading to a NDA filing next year. At that point, attention will turn to the FDA’s acceptance of the phase 3 endpoint. Tricida looked at blood bicarbonate in a belief it is a surrogate for clinical benefits and has discussed the design with the FDA. However, the agency may question the validity of the surrogate endpoint or the level of change needed to achieve clinical benefits when it reviews the NDA.
Even accounting for those issues, Tricida has a far clearer path to market than many other biotechs that have filed for IPOs this year. While its peers have headed to public markets before generating clinical data, Tricida has relied on the support of backers including OrbiMed and, more recently, a loan from Hercules Capital to get within a stone’s throw of an NDA before looking to go public.