Reata Pharmaceuticals is currently recruiting participants for its Phase 3 CATALYST trial assessing the effectiveness of bardoxolone methyl in connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH).
After analysis of the Phase 2 LARIAT study (NCT02036970) results in pulmonary hypertension (PH) and interim data of the first 100 patients in the CATALYST trial (NCT02657356), researchers set the final sample size for this trial at 200 participants.
This planned pooled data analysis to determine the number of participants was performed to ensure the statistical power of the study, while incorporating the baseline characteristics and variability of enrolled participants. The analysis was performed in a blinded manner, with no evaluation of treatment effects, in order to not bias trial results in favor of the therapy and preserve its validity for therapeutic assessment.
As a result of the now higher number of participants needed, the company anticipates it will take at least 12 more months to complete enrollment of the study. This is expected to delay trial completion, and now CATALYST top-line data is anticipated during the first half of 2020, a company spokesperson said in a press release.
During the trial, patients with CTD-PAH are randomized to receive placebo or the investigative treatment, in addition to their ongoing therapy, once daily for six months. Researchers will evaluate the potential of bardoxolone methyl to change exercise capacity, as determined by the six-minute walk test. Researchers will also focus on how quickly patients improve, as well as assess markers of muscle injury and inflammation as indicators of treatment effects.
Patients who wish to participate in the CATALYST trial can visit the study registration webpage, where they can find study site locations and contact details. The study is recruiting at more than 100 sites worldwide.
Bardoxolone methyl is a compound that acts on basic molecular pathways involved in inflammation and damaging oxidation. It activates a factor called Nrf2, which controls several processes that ensure the proper function of mitochondria — the powerhouses of cells.
The U.S. Food and Drug Administration granted bardoxolone methyl orphan drug status for the treatment of PAH and Alport syndrome. The compound is currently being studied in the LARIAT Phase 2 study in PH patients, and in the CARDINAL Phase 2/3 trial (NCT03019185) in Alport syndrome.
Results of the ongoing LARIAT trial have demonstrated the potential of bardoxolone methyl to treat patients with PH associated with interstitial lung disease. Reata has recently reported that treatment improved patients’ kidney function and exercise capacity without adverse outcomes.
The latest LARIAT trial results will be presented at the 55th congress of the European Renal Association and European Dialysis and Transplant Association, taking place May 24-27 in Copenhagen, Denmark. The presentation is titled “Two-Year Durability of Improvements in eGFR with Bardoxolone Methyl in Patients with Pulmonary Arterial Hypertension: The LARIAT Study.”
Bardoxolone methyl is also being evaluated as a potential therapy for rare forms of chronic kidney disease.