Reata Pharmaceuticals has linked its Nrf2 transcription factor activator to improved six-minute walk test results in patients with interstitial lung disease (ILD). The results come from a small, exploratory study Reata initiated after wrapping up a trial of the drug in its primary indication.
Irving, Texas-based Reata has already pushed the drug, bardoxolone methyl, into phase 3 in patients with connective tissue disease associated pulmonary hypertension (CTD-PAH) on the back of midphase evidence of its effect on six-minute walk distances. In parallel, Reata extended the midphase trial to assess the effect of bardoxolone on pulmonary hypertension in patients with two types of ILD: sarcoidosis and idiopathic pulmonary fibrosis (IPF).
Investigators enrolled eight patients with IPF and 25 with sarcoidosis and randomized two-thirds of them to receive bardoxolone once a day for 16 weeks. The rest of the participants took a placebo.
Over 16 weeks, the average six-minute walk distance of IPF patients in the treatment arm increased by 38 meters against baseline. That was enough for the trial to achieve statistical significance against its primary endpoint with a p value of less than 0.05. The distance walked by IPF patients in the placebo group, which wasn’t used as a control for the primary endpoint, fell by 13 meters.
Reata saw a similar, albeit smaller, divergence between the two arms of sarcoidosis patients. The six-minute walk result in the treatment arm went up 17 meters, as compared to a 9 meter fall in the control group.
The readout is a relatively minor event for Reata, particularly when set against the upcoming release of data from the phase 3 trial of bardoxolone. But it opens up another possible avenue for clinical development of bardoxolone down the line.
“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,” Reata CMO Colin Meyer, M.D., said in a statement. “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.”