Therapy for Alport Syndrome Advancing after Stock Sale, Reata Pharmaceuticals Announces
Reata Pharmaceuticals is expecting $115.9 million revenue from the public offering of some of its stock shares, which will support the clinical development of the company’s leading investigational therapy, bardoxolone methyl, for chronic kidney disease (CKD) caused by Alport syndrome.
Bardoxolone is being tested in the Phase 2/3 trial, Cardinal (NCT03019185), currently recruiting participants.
The company, which develops novel therapeutics for patients with serious or life-threatening diseases, announced the closure of the public offering of 3,737,500 shares of its Class A common stock.
Additional clinical programs supported by the sale proceeds include other kidney disorders, Phase 2 programs in pulmonary hypertension (PH) in patients with interstitial lung disease (ILD), and the development of omaveloxolone (RTA-408) for Friedreich’s ataxia and mitochondria-induced muscle diseases (myopathies).
In February the company initiated the international, multi-center, double-blind, randomized, placebo-controlled Phase 2/3 Cardinal trial. The study is investigating the safety, tolerability, and effectiveness of bardoxolone methyl in qualified patients with Alport syndrome. The aim is to investigate if patients show improvements in kidney function, demonstrated either by slowing, halting, or reversing renal function decline.
The trial is enrolling patients aged 12 to 60 years, with estimated glomerular filtration rate (eGFR) values between 30 to 90 mL/min/1.73 m2. The study’s primary goal is to assess the increase in eGFR from baseline to week 12 (Phase 2), or week 48 (Phase 3) in bardoxolone methyl-treated patients when compared to those receiving a placebo. Secondary goals include assessing the changes from baseline in eGFR in bardoxolone methyl-treated patients at week 52, after a period of four weeks without treatment.
Patients enrolled in the trial Phase 2 will be followed for two years with regular eGFR measurements at different intervals, including weeks 48 and 100 on drug, and weeks 52 and 104 after withdrawal of the drug for four weeks. They will not proceed to Phase 3.
Results from the study Phase 2 were announced by the company recently. At the time of that announcement, the Phase 2 part had recruited 30 patients and 90 percent had improved their kidney function by more than what researchers consider a minimal clinically meaningful improvement.
The trial’s Phase 3 will support registration and expects to enroll 180 patients, who will be assigned randomly to either bardoxolone methyl or placebo. The Phase 3 primary efficacy endpoint is the eGFR change from baseline after one year in bardoxolone methyl-treated patients relative to placebo controls. The results are expected in the first half of 2019 and, if Phase 3 delivers positive results, it may serve as the basis for regulatory approval of bardoxolone for Alport kidney disease.