Re: Reata, Friedreich’s Ataxia and Kidney Disease
posted on
Oct 17, 2019 09:50PM
In addition to the success of Reata's omaveloxolone for Friedreich's Ataxia, keep in mind that their other compound bardoxolone is being clinically developed for treatement of several rare kidney diseases. I did a major brain dump post on Reata and Bardoxolone back in June. Some good stuff in that thread that I won't repeat here. Also, on Twitter, @brendan_49 is an expert on Reata and he helped me better understand some of this stuff. Long story short, we're not done hearing about Reata. Both Resverlogix's apabetalone and Reata's bardoxolone could make a huge splash this year in the realm of kidney disease.
Both of Reata's compounds activate the Keap1/Nrf2 pathway. From their company webpage:
"Reata’s lead candidates, bardoxolone methyl and omaveloxolone, are being evaluated in pivotal clinical trials for the treatment of a variety of chronic and genetic diseases for which a substantial unmet need exists. These include: Alport syndrome (AS), Friedreich’s ataxia (FA), connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH), and autosomal dominant polycystic kidney disease–chronic diseases (ADPKD) in which mitochondrial dysfunction and inflammation are implicated. Reata is also evaluating bardoxolone methyl for other rare forms of CKD, including: IgA nephropathy, type 1 diabetic CKD, and focal segmental glomerulosclerosis."
The Phase 2/3 CARDINAL Trial of Bardoxolone in Alport Syndrome is expected to read out one year results by end of 2019.
"The Phase 3 portion of CARDINAL is an international, multi-center, randomized, double-blind, placebo-controlled trial studying the safety and efficacy of bardoxolone methyl (bardoxolone) in patients with chronic kidney disease caused by Alport syndrome. Enrollment in the pivotal Phase 3 portion of CARDINAL was completed last year with 157 patients. We expect to announce one-year, top-line results from CARDINAL in the second half of 2019. The U.S. Food and Drug Administration (FDA) has provided guidance that an improvement in retained estimated glomerular filtration rate (eGFR) versus placebo after 48 weeks of treatment and a four-week drug withdrawal period may support accelerated approval under subpart H. Data demonstrating an improvement versus placebo in retained eGFR after two years may support full approval. No safety concerns have been reported by the data monitoring committee."
Reata news released about 3 upcoming presentations at ASN. In addition, a fourth abstract below reported some potentially worrisome pre-clinical findings in mice related to Nrf2 activation.