Reata Announces Positive Top-Line Data for Treatment of PH-ILD With Bardoxolone Methyl From the Phase 2 Lariat Trial
Significant Improvement in 6MWD in Patients With IPF and Sarcoidosis
No Safety Signals Identified
IRVING, Texas, March 22, 2018 (GLOBE NEWSWIRE) — Reata Pharmaceuticals, Inc. (Nasdaq:RETA) (Reata or Company), a clinical-stage biopharmaceutical company, today announced positive top-line data from the Phase 2 LARIAT trial evaluating bardoxolone methyl (bardoxolone) for the treatment of pulmonary hypertension (PH) in patients with interstitial lung disease (ILD). After demonstrating clinically meaningful improvements in six-minute walk distance (6MWD) in patients with connective tissue disease associated PAH (CTD-PAH), the Company initiated small, exploratory studies in cohorts of pulmonary hypertension due to interstitial lung disease to identify potential expansion opportunities. Results from the trial showed significant improvements in the primary endpoint of the trial, which was change from baseline in 6MWD through week 16, and no safety signals were identified.
The purpose of the trial was to assess effects on 6MWD in patients with PH and idiopathic pulmonary fibrosis (IPF) or sarcoidosis, which are both common forms of ILD. The placebo-controlled trial was 16 weeks in duration, randomized eight patients with IPF and 25 patients with sarcoidosis 2:1 to bardoxolone or placebo, and had sufficient power to detect improvements in 6MWD compared to baseline. There are no available therapies approved specifically to treat patients with PH and ILD because available vasodilators that are approved for pulmonary arterial hypertension have been unable to demonstrate efficacy and safety in these patients.
After 16 weeks of treatment, IPF patients randomized to bardoxolone demonstrated a significant increase in 6MWD from baseline of 38 m (p<0.05) whereas placebo-treated patients had a non-significant reduction of 13 m. Sarcoidosis patients randomized to bardoxolone also demonstrated a significant increase in 6MWD at week 16 from baseline of 17 m (p<0.05) whereas placebo-treated patients had a non-significant increase of 9 m.
“An estimated one half of IPF patients develop pulmonary hypertension, and these patients have rapidly progressive disease and poor outcomes. The magnitude in six-minute walk distance increases observed in IPF patients is as large as the increases we observed in CTD-PAH patients in our Phase 2 LARIAT study,” said Colin Meyer, M.D., Chief Medical Officer of Reata. “We are encouraged by these initial results, especially those in IPF patients, and they support our ongoing efforts in pulmonary hypertension. Once we complete our other ongoing Phase 2 trials, we will evaluate all available data from our mid-stage trials to determine prioritization and timing for this and our other programs.”
About Bardoxolone Methyl
Bardoxolone methyl is an experimental, oral, once-daily activator of Nrf2, a transcription factor that induces molecular pathways that promote the resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, and inhibiting pro-inflammatory signaling. The FDA has granted orphan designation to bardoxolone methyl for the treatment of Alport syndrome and pulmonary arterial hypertension. Bardoxolone methyl is currently being studied in CARDINAL, a Phase 3 study for the treatment of Alport syndrome, and CATALYST, a Phase 3 study for the treatment of CTD-PAH.
About Reata Pharmaceuticals, Inc.
Reata is a clinical-stage biopharmaceutical company that develops novel therapeutics for patients with serious or life-threatening diseases by targeting molecular pathways involved in the regulation of cellular metabolism and inflammation. Reata’s two most advanced clinical candidates, bardoxolone methyl and omaveloxolone, target the important transcription factor Nrf2 that promotes the resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, and inhibiting pro-inflammatory signaling.
This press release includes certain disclosures that contain “forward-looking statements,” including, without limitation, statements regarding the success, cost and timing of our product development activities and clinical trials, our plans to research, develop and commercialize our product candidates, and our ability to obtain and retain regulatory approval of our product candidates. You can identify forward-looking statements because they contain words such as “believes,” “will,” “may,” “aims,” “plans,” and “expects.” Forward-looking statements are based on Reata’s current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to, (i) the timing, costs, conduct, and outcome of our clinical trials and future preclinical studies and clinical trials, including the timing of the initiation and availability of data from such trials; (ii) the timing and likelihood of regulatory filings and approvals for our product candidates; (iii) the potential market size and the size of the patient populations for our product candidates, if approved for commercial use, and the market opportunities for our product candidates; and (iv) other factors set forth in Reata’s filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K, under the caption “Risk Factors.” The forward-looking statements speak only as of the date made and, other than as required by law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
Vice President, Strategy
Matt Middleman, M.D.
LifeSci Public Relations
Source: Reata Pharmaceuticals, Inc.