Yahoo Finance Reata Pharma (RETA) is Striving Hard Despite Pipeline Setbacks
Reata Pharmaceuticals RETA is a clinical-stage biopharma company focused on developing small molecule therapies for life-threatening diseases with few treatment options. The company currently has no marketed drugs in its portfolio.
However, the company is developing two of its lead pipeline candidates, namely, omaveloxolone in Friedreich’s ataxia (“FA”) and bardoxolone in rare forms of chronic kidney disease (CKD).
Reata reacquired the ex-US rights to develop, manufacture and commercialize bardoxolone and worldwide rights for omaveloxolone and its proprietary Nrf2 product platform from AbbVie ABBV in 2019.
Reata made a cash payment of $330 million to AbbVie as a consideration for the reacquisition of the rights, primarily for rights to bardoxolone.
Reata completed the rolling submission of a new drug application (NDA) to the FDA for omaveloxolone for treating FA in March 2022.
In May, the FDA accepted the company’s NDA for filing and granted priority review.
FA patients do not have an effective treatment option as of yet. A shorter review period also implied a significant need for a treatment option for this patient population.
In August, the company reported that the FDA extended its review timeline for the NDA for omaveloxolone for FA by almost three months.
Reata had a mid-cycle meeting with the FDA in the first quarter, in which the FDA raised concerns regarding the strength of the omaveloxolone’s efficacy evidence.
Post the meeting, as confirmatory evidence, the company submitted additional data from the long-term MOXIe extension study from the March 22 data. The company also provided a propensity score matched comparison of the mFARs subjects in the largest natural history study of FA to the mFARS progression of omaveloxolone-treated patients in its MOXIe Extension study. In addition, Reata submitted mechanistic action data validating Nrf2 in the pathophysiology of FA. Clinical biomarker data showing that omaveloxolone-induced Nrf2 activity in subjects of the MOXIe part II study was associated with improvements in mFARS scores was also submitted.
Thus, a decision from the FDA on the potential approval of omaveloxolone is now expected by Feb 28, 2023.
A potential approval will make omaveloxolone the first FDA-approved therapy for the rare genetic neuromuscular disorder, Friedreich’s ataxia. Reata expects to launch the candidate in early 2023.
The company intends to file a regulatory application seeking approval for omaveloxolone as a treatment for FA patients in Europe in the fourth quarter of 2022.
In March 2021, Reata had submitted an NDA to the FDA for bardoxolone for treating CKD caused by Alport syndrome. However, in February 2022, the company’s prospects were hurt as it received a complete response letter (CRL) from the FDA for bardoxolone indicating that the NDA cannot be approved in its present form. Reata has requested a Type C meeting with the FDA to decide the next step forward for bardoxolone in the aforementioned indication.
Reata is also developing bardoxolone for treating autosomal dominant polycystic kidney disease (“ADPKD”) in a late-stage study. The company recently filed a protocol amendment and requested a Type A meeting with the FDA to discuss the ADPKD development program.
Moreover, Reata faces stiff competition in its target market since several companies are developing candidates for similar indications.
AstraZeneca’s AZN Farxiga (dapagliflozin) was approved by the FDA in May 2021 for treating adults with CKD at risk of progression. AstraZeneca’s CKD drug may prove to be a competition for Reata’s bardoxolone, post approval.
Eli Lilly’s Jardiance is also being developed for CKD and other inflammatory kidney diseases. It has also been granted Fast Track designation by the FDA.
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