Breaking News
July 21, 2018 - Whole-brain LIPUS therapy improves cognitive dysfunction in mice simulating dementia, Alzheimer’s
July 21, 2018 - Digital media use raising risk of ADHD symptoms among the young
July 21, 2018 - Phase 3 study of tanezumab in patients with osteoarthritis pain meets all three co-primary endpoints
July 21, 2018 - Restoring mitochondrial function to reverse aging-related skin wrinkles, hair loss in mice
July 21, 2018 - SP PennTech introduces RW-500 rotary vial washer for biotech, pharmaceutical applications
July 21, 2018 - Researchers to study molecular mechanisms behind susceptibility of males to autism
July 21, 2018 - Fourth Published Clinical Trial Confirms Long-Term Safety of Niagen Supplementation at High Doses and Shows Potential for Improvement in Liver Health
July 21, 2018 - Parents say intense gun violence in PG-13 movies appropriate for teens 15 and older
July 21, 2018 - FAU researchers find possible cause of Parkinson’s disease in the patients’ immune system
July 21, 2018 - Protective qualities of ‘good cholesterol’ reduce after menopause
July 21, 2018 - Researchers develop new way to uncover hidden breast cancer tumors
July 21, 2018 - FDA approves first drug for treatment of adult AML patients with specific genetic mutation
July 21, 2018 - Top AI companies join hands to discover novel drugs for DMD
July 21, 2018 - Ferring announces FDA approval of ZOMACTON for injection in four new pediatric indications
July 20, 2018 - Researchers design proteins that can self-assemble into complex structures
July 20, 2018 - AVITA Medical expands management team to support launch of RECELL device to treat burns
July 20, 2018 - FDA Approves Tibsovo (ivosidenib) for Relapsed or Refractory Acute Myeloid Leukemia with an IDH1 Mutation
July 20, 2018 - Developmental screening and surveillance rates remain low, new study suggests
July 20, 2018 - TGen opens tissue donation portal to advance DIPG research
July 20, 2018 - Health impact of highly processed summertime staples
July 20, 2018 - Exergaming can improve health in overweight and obese children, study shows
July 20, 2018 - Postmenopausal factors may impact heart-protective qualities of ‘good cholesterol’
July 20, 2018 - MRI and blood test combination results in improved prostate cancer diagnosis
July 20, 2018 - Update Health Professional and Consumer on Recent Recalled Products
July 20, 2018 - Researchers trace Parkinson’s damage in the heart
July 20, 2018 - Wearable device designed to measure cortisol in sweat
July 20, 2018 - Scientists demonstrate a new regulation mechanism for skeletal muscles
July 20, 2018 - Exposure to mobile phone radiation may negatively impact memory performance in adolescents
July 20, 2018 - SUSU scientists find alternative method to treat post-traumatic stress disorder syndrome
July 20, 2018 - Gestational diabetes may increase offspring’s heart disease risk
July 20, 2018 - New vaccine could protect unborn babies from Zika virus
July 20, 2018 - Researchers find high mercury and methylmercury concentrations in traditional Tibetan medicine
July 20, 2018 - Brief Safety Plan Intervention in ER Can Cut Suicidal Behavior
July 20, 2018 - Toward a better understanding of Parkinson’s disease
July 20, 2018 - Med school communications office wins four national awards | News Center
July 20, 2018 - Professional baseball players with faster hand-eye coordination may have better batting performance
July 20, 2018 - Study looks into mechanisms that control sleep and wakefulness
July 20, 2018 - Scientists identify melanoma biomarkers that could help tailor immunotherapy treatments
July 20, 2018 - Research reveals long-term efficacy of drug used to treat common cause of kidney failure
July 20, 2018 - Timing of dinner associated with breast and prostate cancer risks
July 20, 2018 - Health Tip: Performing the Heimlich Maneuver
July 20, 2018 - Nearly all adolescents have eating, activity or weight-related issues
July 20, 2018 - Sage launches new web-based tool that helps explore curated genomic analyses of Alzheimer’s
July 20, 2018 - High-performance porous polymeric material for chromatography applications
July 20, 2018 - New molecule shows great promise for future treatment of many cancers
July 20, 2018 - New research project investigates alternative treatments for eye infections
July 20, 2018 - Immune T cells are built to react as fast as possible, shows study
July 20, 2018 - ZHX2 protein could offer a new treatment strategy for kidney cancer
July 20, 2018 - EKF’s Quo-Lab POC HbA1c analyzer meets international quality targets for diabetes testing
July 20, 2018 - Health burdens of very high risk drinking are potentially large, study reveals
July 20, 2018 - Using miniature drug-filled nanocarriers to target headaches and tumors
July 20, 2018 - Researchers uncover cause for progression of prostate cancer to incurable stage
July 20, 2018 - Studies highlight issues regarding black lung, opioid overdose, police violence and more
July 20, 2018 - AbbVie submits supplemental NDA to FDA for venetoclax to treat acute myeloid leukemia
July 20, 2018 - Researchers are one step closer to developing eye drops to treat age-related macular degeneration (AMD)
July 20, 2018 - Patients maintain muscle mass five years after surgically induced weight loss
July 20, 2018 - AMSBIO introduces new, powerful CRISPR/Cas9 gene editing kits
July 20, 2018 - PureTech Health collaborates with Roche to advance oral administration of antisense oligonucleotides
July 20, 2018 - Analysis reveals disparities in cancer death rates among minority groups
July 20, 2018 - Dr Maddy Parsons receives Royal Microscopical Society Life Science Medal
July 20, 2018 - Study finds link between DNA methylation and non-alcoholic fatty liver disease
July 20, 2018 - Military personnel with head trauma and football players with suspected CTE show similar brain changes
July 20, 2018 - Vidac Pharma Announces Initiation of Phase 2b Clinical Trial of VDA-1102 Ointment in Patients with Actinic Keratosis
July 20, 2018 - KKR is buying Envision Healthcare in a nearly $10B deal
July 20, 2018 - Older people with broken bones face higher risk of death for up to 10 years
July 20, 2018 - A simple pill for meth addicts on the cards
July 20, 2018 - UA researchers to repurpose ketamine to reduce side effects in Parkinson’s patients
July 20, 2018 - Child psychiatrist available on call to help assess separated immigrant children
July 20, 2018 - High bitter-taste sensitivity linked to increased risk of cancer
July 20, 2018 - Falling temperatures may lead to rise in numbers of deaths from stroke
July 20, 2018 - Supplemental oxygen prevents rise in morning blood pressure in OSA patients
July 20, 2018 - High fruit and vegetable intake linked to reduced risk of breast cancer
July 20, 2018 - Careful patient selection may help achieve good outcomes for vaginal mesh surgery
July 20, 2018 - Researchers raise viability of cloned mice using somatic cell nuclear transfer method
July 20, 2018 - 3HP for Latent TB Infection Treatment | 2018 | Newsroom | NCHHSTP
July 20, 2018 - An orange a day keeps macular degeneration away: 15-year study
July 20, 2018 - Researchers elucidate how the brain drives trial-by-trial adaptation to compensate for errors
July 20, 2018 - Understanding triple-negative breast cancer to develop better treatments
July 20, 2018 - Study compares outpatient antibiotic prescribing with traditional medical, retail clinic settings
July 20, 2018 - Immediate Monitoring With ECG Patch Ups A-Fib Diagnosis Rate
Reata Announces Positive Top-Line Data for Treatment of PH-ILD With Bardoxolone Methyl From the Phase 2 Lariat Trial

Reata Announces Positive Top-Line Data for Treatment of PH-ILD With Bardoxolone Methyl From the Phase 2 Lariat Trial

image_pdfDownload PDFimage_print

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

“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.

Forward-Looking Statements

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.

Source: Reata Pharmaceuticals, Inc.

Posted: March 2018

Tagged with:

About author

Related Articles