Reata Pharmaceuticals has reacquired development, manufacturing, and marketing rights for its proprietary Nrf2 activator products — including bardoxolone methyl (bardoxolone) for the treatment of Alport syndrome and omaveloxolone for Friedreich’s ataxia — the company announced.
This follows the termination of a partnership with AbbVie, which had owned full rights to bardoxolone in territories outside the U.S., and worldwide rights to omaveloxolone and other next-generation Nrf2 activators.
Despite these licensing changes, Kyowa Kirin still holds bardoxolone’s licensing rights within some Asian territories.
“AbbVie has been an excellent partner, and our collaboration was instrumental in the clinical development of bardoxolone and omaveloxolone,” Warren Huff, Reata’s CEO and president, said in a press release. “Regaining these rights will increase Reata’s strategic flexibility and control regarding the development and commercialization of our lead drug candidates, and our next-generation Nrf2 activators.”
To achieve this goal, Reata entered into an amendment to its loan and security agreement with Oxford Finance and Silicon Valley Bank, which will ensure a total of $75 million to support the development of the company’s Nrf2 activators.
This amendment is dependent on positive data from either Reata’s ongoing Phase 2/3 CARDINAL study (NCT03019185), testing bardoxolone in people with Alport syndrome, or the MOXIe study (NCT02255435), which is assessing omaveloxolone as a treatment for Friedreich’s ataxia.
“We have been actively preparing for the commercial launch of bardoxolone and omaveloxolone in the United States, and we will now expand our efforts to include these international territories as well,” Huff said.
Bardoxolone is a small molecule compound aimed at reducing oxidative stress and inflammation, which are critical contributors for progressive kidney function deterioration in Alport syndrome.
By preventing the degradation of Nrf2 protein and stimulating its activity, bardoxolone can induce the production of anti-oxidant proteins and improve mitochondria function as the “powerhouses” of cells.
Results from the Phase 2 portion of the ongoing CARDINAL study have demonstrated that one year of treatment with bardoxolone can induce recovery of kidney function, and prevent the damaging effects of Alport syndrome.
Clinical data specifically showed that, after 48 weeks of treatment, 22 of 25 bardoxolone-treated patients experienced significant improvements in renal function compared with the start of the study.
The CARDINAL Phase 3 part is still ongoing. It is exploring the impact of oral, once-daily bardoxolone treatment in 157 people with Alport recruited across more than 60 sites worldwide.
Both the U.S. Food and Drug Administration and the European Medicines Agency have granted orphan drug designation to bardoxolone for the treatment of Alport syndrome. This designation recognizes the therapy’s potential for treating people affected by this rare inheritable disease. Moreover, it supports and expedites bardoxolone’s development and marketing.
AbbVie will receive $330 million in cash, primarily for rights to bardoxolone, as consideration for the rights reacquired by Reata. In addition, AbbVie will receive royalties from worldwide sales of omaveloxolone and certain next-generation Nrf2 activators, according to Reata.