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Reata's Bardoxolone Methyl Demonstrated Improved Kidney Function in Patients With Alport Syndrome in Ongoing Phase 2 Portion of Phase 2/3 Cardinal Study

Jul 24, 2017 (GLOBE NEWSWIRE via COMTEX) --

SCREENING OF PATIENTS IN PHASE 3 PORTION OF CARDINAL UNDERWAY

PLANNING TO INITIATE ADDITIONAL RARE CHRONIC KIDNEY DISEASE PROGRAMS

CONFERENCE CALL WITH MANAGEMENT SCHEDULED TODAY AT 8:30AM ET

IRVING, Texas, July 24, 2017 (GLOBE NEWSWIRE) -- Reata Pharmaceuticals Inc. RETA, +2.17% ("Reata" or "the Company") today reported initial data from the ongoing open-label Phase 2 portion of CARDINAL, a Phase 2/3 trial evaluating bardoxolone methyl ("bardoxolone") in patients with chronic kidney disease ("CKD") caused by Alport syndrome. Based upon these data, the Company has initiated screening in the Phase 3 portion of the trial and is planning to launch additional Phase 2 studies in rare renal diseases during the first half of 2018.

The Phase 2 portion of the trial enrolled 30 patients, and all patients remain on study. The available data demonstrate that bardoxolone significantly improved kidney function in Alport syndrome patients as measured by estimated glomerular filtration rate ("eGFR"). From a mean baseline eGFR of 54.7 mL/min/1.73 m [2] , available data showed a mean improvement of 6.9 mL/min/1.73 m [2] at Week 4 (n=19; p<0.0005), increasing to 12.7 mL/min/1.73 m [2] at Week 12 (n=8; p<0.00005). Over 80% of patients demonstrated a clinically meaningful improvement in eGFR of at least 3.0 mL/min/1.73 m [2] by Week 8, and the 95% confidence interval at Week 12 was 7.9 mL/min/1.73 m [2] to 17.5 mL/min/1.73 m [2] . The observed treatment effect surpasses the threshold of 3.0 mL/min/1.73 m [2] that was the minimum effect size necessary to proceed to the Phase 3 portion of the trial. No serious adverse events have been reported in the trial, and reported adverse events have generally been mild to moderate in intensity. The independent data monitoring committee reviewed all available safety data and voted to recommend opening the Phase 3 portion of the trial.

"The ongoing Phase 2 portion of CARDINAL demonstrated clear improvements in renal function that are large in magnitude, occur in a high percentage of patients, and are highly statistically significant," said Colin Meyer, M.D., Chief Medical Officer of Reata. "These results exceeded our expectations and bring us one step closer to the prospect of bardoxolone becoming the first effective treatment for this severe and life-threatening disease. We are eager to study bardoxolone in additional, rare renal diseases driven by inflammatory processes that bardoxolone addresses."

"The Alport Syndrome Foundation has worked for 10 years to encourage the development of therapies that will delay or prevent the need for dialysis and transplantation in patients with Alport syndrome, and we are encouraged to see this trial move forward and hope this will bring us closer to achieving our vision, to conquer Alport syndrome," said Gina Parziale, Executive Director of the Alport Syndrome Foundation. "As there are no FDA-approved therapies to treat Alport syndrome, we are grateful to Reata for addressing this need and for engaging us in the process to ensure the patient perspective is incorporated."

CONFERENCE CALL INFORMATION
Time: 8:30AM ET
Audience Dial-in (toll-free): (844) 348-3946
Audience Dial-in (international): (213) 358-0892
Passcode: 59143438
Webcast Link: https://edge.media-server.com/m6/p/6frccxcz

About the CARDINAL Clinical Study Design

CARDINAL is an international, multi-center Phase 2/3 study enrolling patients from 12 to 60 years old with a confirmed...


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