Reata Pharmaceutical PH-ILD Drug Bardoxolone Methyl Clinical Phase 2 Positive
March 23, 2018 Source: Sina Pharmaceutical
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];On March 22, Reata, a US clinical stage biopharmaceutical company, announced that the company's clinical trial of LARIAT, which was used to evaluate bardoxolone methyl (bardoxolone) for pulmonary hypertension (PH-ILD) in patients with interstitial lung disease, was positive. Top line research data.
After confirming the clinical significance of the 6-minute walking distance (6 MWD) in patients with connective tissue disease-associated pulmonary hypertension (CTD-PAH), the company conducted a small exploratory cohort of patients with pulmonary hypertension caused by interstitial lung disease. Research to determine the potential for extended application of the drug. The results of this trial showed a significant improvement in the primary endpoint of the trial (from baseline 6 MWD to change in week 16) and no safety signals were found.
The aim of the trial was to evaluate the effects of PH and idiopathic pulmonary fibrosis (IPF) or sarcoidosis on 6 MWD, a common form of interstitial lung disease. The placebo-controlled trial lasted for 16 weeks, and 8 patients with IPF and 25 patients with sarcoidosis were randomized to receive bardoxolone or placebo at 2:1, respectively, to improve 6 MWD compared to baseline. There are currently no effective treatments approved for the treatment of patients with PH and ILD, as vasodilators that can be used for pulmonary hypertension do not show efficacy and safety in these patients.
After 16 weeks of treatment, 6 MWD in patients with IPF who were randomized to bardoxolone was significantly higher than baseline 38 m (p < 0.05), whereas in the placebo group there was a non-significant reduction (13 m). The 6 MWD level at week 16 was also significantly higher than the baseline value of 17 m (p < 0.05) in patients with sarcoids treated with bardoxolone, whereas there was no significant increase in 9 m in placebo-treated patients.
Dr. Colin Meyer, Chief Medical Officer of Reata Pharmaceuticals, said: "It is estimated that half of IPF patients have pulmonary hypertension, and these patients progress rapidly and have a poor prognosis. The magnitude of the increase in 6 MWD observed in patients with IPF is the same as ours. The increase in CTD-PAH patients observed in the Phase 2 LARIAT study was equally large. We are encouraged by these preliminary results, especially in the IPF patients, which support our current efforts in pulmonary hypertension. Once we have completed In other ongoing Phase 2 trials, we will evaluate all available data in all mid-term trials to prioritize and schedule this project with our other projects."
Bardoxolone methyl is an experimental oral Nrf 2 activator. Nrf 2 acts as a transcription factor that induces inflammatory responses by restoring mitochondrial function, reducing oxidative stress, and inhibiting pro-inflammatory signaling. The US FDA has granted bardoxolone methyl status as an orphan drug for treatment of Alport syndrome and pulmonary hypertension. Bardoxolone methyl is currently undergoing a Phase 3 clinical trial called CARDINAL for the treatment of Alport syndrome, and a phase 3 trial of CATALYST for CTD-PAH treatment. (Sina Pharmaceutical Compilation / David)
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