Reata buoyed by positive data for kidney disease drug
- Shares in Reata Pharmaceuticals Inc. jumped more than 10% on Monday morning, responding to data the Texas-based biopharma reported over the weekend that showed its drug bardoxolone methyl helped patients with chronic kidney disease (CKD) caused by Alport syndrome.
- All 30 patients enrolled in the Phase 2 study saw increases in estimated glomerular filtration rate (eGFR), a measure of kidney function. Nearly nine in ten participants experienced an eGFR increase roughly equivalent to the annual rate of functional decline typically seen in Alport syndrome.
- Treatment with bardoxolone led to an improvement in CKD stage for 22 of 30 patients in the trial, dubbed CARDINAL. Reata is currently enrolling patients for the pivotal Phase 3 portion of the study.
The results reported from the American Society of Nephrology's annual meeting square with interim data presented in July from eight patients, showing similar efficacy across the full 30-patient cohort.
"The investigators from the trial we spoke with are enthusiastic about the results and the drug's overall profile," wrote Jefferies analyst Maury Rycroft in a note on the data. "In addition to having a major benefit on eGFR, which should ultimately delay time to transplant, patients are also improving in CKD score [which is] meaningful to the broader CKD market."
Rycroft also noted that key opinion leaders at the conference described the increased levels of muscle spasms in the treatment group as "mild" and "not concerning," supporting the company's characterization of the drug's safety profile.
Alport syndrome is a progressive genetic disease that leads to loss of kidney function, as well as affecting hearing and vision. There are currently no FDA-approved treatments for the condition, which affects roughly 12,000 people in the U.S., according to Reata.
Bardoxolone methyl carries an Orphan Drug Designation from the FDA for this indication, although Reata believes the drug has broader potential due to its mechanism of action in blocking pro-inflammatory signaling.
"We believe that bardoxolone may impact a diverse set of kidney indications where inflammation, remodeling, and fibrosis are also central to the loss of kidney function, and we are optimistic that bardoxolone can be a meaningful treatment option for patients with these severe and underserved forms of CKD," said Colin Meyer, Reata's chief medical officer, in a Nov. 6 statement.
Reata has already launched the pivotal Phase 3 portion of the CARDINAL study, aiming to enroll as many as 150 patients. Data from that trial are expected in the second half of 2019.
In addition, however, the company said it would also study bardoxolone in four other rare forms of CKD, with multiple 20- to 30-patient cohorts. Results from those groups is slated to read out in the second half of 2018 and into 2019.
Reata is partnered with the Japanese biopharma Kyowa Hakkin Kirin Co., Ltd. on bardoxolone.
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