Benzinga - Reata Pharmaceuticals Inc (NASDAQ: RETA) and its partner Kyowa Kirin Co Ltd have decided to discontinue bardoxolone chronic kidney disease programs.
In May 2023, Kyowa Kirin announced data from the AYAME Phase 3 trial of bardoxolone in 1,013 patients treated with 5 to 15 mg of bardoxolone or a placebo for three to four years.
The primary endpoint of the study was the time to onset of a ≥ 30% decrease in estimated Glomerular Filtration Rate (eGFR) from baseline or end-stage renal disease (ESRD).
The AYAME study met the primary and key secondary endpoints, and no significant safety issues were observed. However, there was no separation in the occurrence of ESRD events between the bardoxolone and placebo groups after three years of treatment.
As a result of the discontinuation of bardoxolone development, Reata has amended the development and commercialization funding agreement with Blackstone Life Sciences.
Under the terms of the amended agreement, all obligations for the development and commercialization of bardoxolone, restrictions on debt financing, restrictions on licensing assets, and all prior security interests have been removed.
Reata will pay Blackstone a low, single-digit royalty on worldwide net sales of omaveloxolone for FA.
In May, the company entered into a debt facility with Pharmakon Advisors for an aggregate principal amount of up to $275 million to be advanced in four tranches.
Based on the company's current operating plans, its existing cash balance plus funds available from its new debt facility will be sufficient to fund operations through the end of 2026.
Price Action: RETA shares are down 19.4% at $84.97 on the last check Wednesday.
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