Life Science News

Reata Pharmaceuticals (Nasdaq:RETA), a clinical-stage biopharmaceutical company, today announced that it has completed a successful end-of-Phase 2 meeting with the United States Food and Drug Administration (FDA) regarding the design of a Phase 3 clinical trial of bardoxolone methyl (bardoxolone) in patients with autosomal dominant polycystic kidney disease (ADPKD). As quoted in the press release: …

Reata Pharmaceuticals (Nasdaq:RETA), a clinical-stage biopharmaceutical company, today announced that it has completed a successful end-of-Phase 2 meeting with the United States Food and Drug Administration (FDA) regarding the design of a Phase 3 clinical trial of bardoxolone methyl (bardoxolone) in patients with autosomal dominant polycystic kidney disease (ADPKD).

As quoted in the press release:

The trial, named FALCON, will be an international, double-blind, placebo-controlled, parallel group, Phase 3 trial.  The Company plans to enroll approximately 300 ADPKD patients randomized 1:1 to oral, once-daily bardoxolone or placebo.  The trial will include ADPKD patients from 18 to 70 years old with an estimated glomerular filtration rate (eGFR) between 30 to 90 mL/min/1.73 m2.  The primary efficacy endpoint is the change from baseline in eGFR compared to placebo after 48 weeks of treatment followed by a 4-week drug withdrawal period, the retained eGFR benefit.

FALCON is statistically powered to detect a placebo-corrected, retained eGFR benefit of 1.6 mL/min/1.73 m2.  Based upon guidance from the FDA, the 52-week retained eGFR benefit data may support accelerated approval under subpart H.  After Week 52, patients will be restarted on study drug with their original treatment assignments and will continue on study for a second year.  The second-year retained eGFR benefit will be measured at Week 104 after withdrawal of drug for four weeks.  Based upon guidance from the FDA, the year-two retained eGFR benefit data may support full approval.

Click here to read the full press release.

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