Breaking News
September 23, 2018 - HIV and a tale of a few cities
September 23, 2018 - NIH launches clinical trial to test infusions of combination antibodies in people with HIV
September 23, 2018 - Researchers develop new system to detect consumption of synthetic cannabinoids
September 23, 2018 - Vax-Hub to influenze radical change in development and manufacturing of vaccines
September 23, 2018 - People who have slept lesser than seven hours have higher risks of car crashes
September 23, 2018 - an ancient art may work best to prevent falls in old age
September 23, 2018 - Consumption of foods with lower nutritional quality related to increased cancer risk
September 23, 2018 - Patient Health Information Often Shared Electronically
September 23, 2018 - Can machine learning bring more humanity to health care?
September 23, 2018 - Body organs undergo structural changes in response to diet
September 23, 2018 - Genetic polymorphisms linked with muscle injury and stiffness
September 23, 2018 - As states try to rein in drug spending, feds slap down one bold Medicaid move
September 22, 2018 - Why Eczema Is Tougher to Treat for Black Patients
September 22, 2018 - Team reveals that human genome could contain up to 20 percent fewer genes
September 22, 2018 - USC research uncovers previously unknown genetic risk factor for Alzheimer’s disease
September 22, 2018 - Novel method achieves accurate and precise temperature estimation in fat-containing tissues
September 22, 2018 - BSI accredits Oxehealth’s vital signs measurement software as Class IIa medical device
September 22, 2018 - Evolution of psychiatric disorders and human personality traits
September 22, 2018 - Obesity in early puberty doubles asthma risk for boy’s future offspring
September 22, 2018 - World’s most advanced real-time patient monitoring platform receives key US patent
September 22, 2018 - Study explores connection between sexuality and cognitive status in older adults
September 22, 2018 - LSTM partners with TB Alliance to develop novel TB drug regimens
September 22, 2018 - Annual wellness visits improve delivery of preventive services in elderly population
September 22, 2018 - CHMP provides positive opinion to Cabometyx for previously-treated patients with hepatocellular carcinoma
September 22, 2018 - Hispanic communities with high proportions of Hispanics face more cardiovascular-related death
September 22, 2018 - Vici syndrome – Genetics Home Reference
September 22, 2018 - Single-dose drug can shorten flu symptoms by about a day, studies suggest
September 22, 2018 - AMSBIO launches circulating tumor DNA Reference Standards
September 22, 2018 - Sandalwood mimicking odorant could stimulate hair growth in humans
September 22, 2018 - Overlooked immune cells could play a key role in cancer immunotherapy, claims new study
September 22, 2018 - Study reveals prevalence of diagnosed type 1 and type 2 diabetes among American adults
September 22, 2018 - Researchers develop fast detection strategy to know type of virus acquired by patients
September 22, 2018 - Global Prevalence of Insufficient Activity 27.5 Percent
September 22, 2018 - Strategies to protect bone health in hematologic stem cell transplant recipients
September 22, 2018 - Brigham Genomic Medicine program unravels 30 medical mysteries
September 22, 2018 - New system harnesses power of bubbles to destroy dangerous biofilms
September 22, 2018 - Inflammation plays crucial role in preventing heart attacks and strokes, study reveals
September 22, 2018 - Calorie dense, nutrient deficient meals common across the world
September 22, 2018 - Researchers develop technology to study behavior of implants without animal testing
September 22, 2018 - First gut bacteria in newborns may have lasting effect on ability to ward off chronic diseases
September 22, 2018 - Detection of BFD virus in parrots in 8 new countries raises concerns for threatened species
September 22, 2018 - Insulin treatment shows great potential against chronic bowel inflammation
September 22, 2018 - ‘Liking Gap’ Might Stand in Way of New Friendships
September 22, 2018 - Simple factors that can avoid harmful side effects in type 2 diabetes
September 22, 2018 - ALSAM Foundation invests additional $2 million for drug discovery and development projects
September 22, 2018 - Study findings may advance discussion of how to effectively curb human-wildlife conflict
September 22, 2018 - Dopamine neurons may involve in conditions ranging from Parkinson’s disease to schizophrenia
September 22, 2018 - Protein C and Protein S Tests: MedlinePlus Lab Test Information
September 22, 2018 - Obesity and diabetes—two reasons why we should be worried about the plastics that surround us
September 22, 2018 - Concern over fussy eating prompts parents to use non-responsive feeding practices
September 22, 2018 - Novel mathematical approach uncovers existence of unsuspected biological cycles
September 22, 2018 - Cancer Research UK invests £14 million to transform London into cancer biotherapeutics hub
September 22, 2018 - Scientists predict how well the body will fight lung cancer by analyzing immune cell shapes
September 22, 2018 - New outbreak of rare eye disease identified in contact lens wearers
September 22, 2018 - Iterum Initiates SURE 2 and SURE 3 Phase 3 Clinical Trials of IV and Oral Sulopenem in Complicated Urinary Tract and Complicated Intra-abdominal Infections
September 22, 2018 - Research finds divide in dental health accessibility between city and regional areas
September 22, 2018 - Premature babies show better brain development when fed breast milk, finds study
September 22, 2018 - Novel system uses AI to detect abnormalities in fetal hearts
September 22, 2018 - UNC scientists reveal new approach to prevent obesity and diabetes
September 22, 2018 - CWRU receives NIH grant to learn how non-coding genes contribute to spread of colorectal cancer
September 22, 2018 - Scientists better understand influenza virus and how it spreads
September 22, 2018 - Scientists to focus on length of time when a person is alive and healthy
September 22, 2018 - Study shows positive financial impacts of Medicaid expansion for low-income Michigan residents
September 22, 2018 - Innovative approach for developing vaccine against most prevalent human malaria parasite
September 22, 2018 - Study finds excess emissions from diesel cars produced by major auto manufacturers in Europe
September 22, 2018 - Decision aids for parents of children with minor head injuries help communicate with physicians
September 22, 2018 - Research scientist at Kessler Foundation receives $10,000 grant to study aphasia after stroke
September 22, 2018 - New findings on characteristics of Burning Mouth Syndrome
September 22, 2018 - Study sheds light on molecular mechanisms underlying progression of prion diseases
September 22, 2018 - Innovation Fund Denmark supports research project that aims to fight Clostridium difficile diarrhea
September 22, 2018 - Survey estimates caregiving costs for family members
September 22, 2018 - Inhibiting NF-kB improves heart function in a mouse model of Duchenne muscular dystrophy
September 22, 2018 - Introducing new EMR system may affect several aspects of clinic workflow
September 22, 2018 - Study finds why some human genes are more popular with biomedical researchers
September 22, 2018 - Finding epigenetic signature appears to predict inflammation risk in serious type of IBD
September 22, 2018 - Researchers develop light-based technique to measure very weak magnetic fields
September 22, 2018 - UAB researchers study dysfunction of the immune system associated with NSAID carprofen
September 22, 2018 - QIAGEN and DiaSorin launch automated, CE-marked workflow for high-throughput TB screening
September 22, 2018 - EFS checklist provides user-friendly tool for evaluating feeding skills in preterm infants
September 22, 2018 - Family history in blacks, Latinos associated with higher risk of AFib
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