Reata Pharmaceuticals, a clinical-stage biopharmaceutical company recently announced enrollment of first patient in the Phase 3 FALCON trial of bardoxolone in patients with ADPKD (autosomal dominant polycystic kidney disease), cites source.

For the record, Bardoxolone is an experimental oral activator of NrF2, that induces molecular pathways to restore mitochondrial functioning, inhibiting pro-inflammatory signaling & reducing oxidative stress. The drug has been granted orphan drug designation to treat pulmonary arterial hypertension & Alport syndrome by FDA.

Warren Huff, Reata’s Chief Executive Officer & President was reportedly quoted saying that autosomal dominant polycystic kidney disease is a commonly inherited form of chronic kidney disease.  Even with standard treatment, by 60 years of age, approximately 50% of the ADPKD patients will progress to end-stage kidney disease.

Huff added that significant improvements have been observed in kidney functions in the Phase 2 PHOENIX study of ADPKD cohort. Historically, strong correlations are observed between eGFR after 12 weeks of Bardoxolone Methyl treatment & 1 year retained eGFR benefits in other forms of chronic kidney diseases. Bardoxolone Methyl is expected to serve as a meaningful treatment option for patients with autosomal dominant polycystic kidney disease.

FALCON is an international trial that is studying efficiency & safety of Bardoxolone Methyl in 300 patients with autosomal dominant polycystic kidney disease, randomized evenly to active or placebo drug. The trial is expected to enroll a broad range of patients of age 18-70 years, with an estimated eGFR (estimated glomerular filtration rate) between 30-90 ml/min/1.73 m2. 

The chief efficacy endpoint for FALCON is change from baseline estimated glomerular filtration rate compared to placebo after 48 weeks of treatment, which is followed by a 4-week drug withdrawal period, also known as retained eGFR benefit. Based upon guidance from USFDA, an analysis of retained eGFR indicating an improvement than placebo after 1 year of bardoxolone treatment might aid approval. Also, an improvement than placebo after 2 years of treatment, might aid full approval.

Source credits : https://www.globenewswire.com/news-release/2019/05/30/1859256/0/en/Reata-Announces-First-Patient-Enrolled-in-Phase-3-FALCON-Trial-of-Bardoxolone-Methyl-for-the-Treatment-of-Autosomal-Dominant-Polycystic-Kidney-Disease.html