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Your Daily Pharma Scoop: Reata Provides Update, Assembly Biosciences Data, Bellicum's BPX-501


  • Reata provided an update on the CARDINAL study of bardoxolone.
  • Assembly Biosciences reports results for ABI-H0731.
  • FDA lifts clinical hold on Bellicum’s BPX-501 studies.

Analysis focus: Reata Pharmaceuticals

Today we will discuss Reata Pharmaceuticals (NASDAQ:RETA), which provided an update on the phase 2 portion of the CARDINAL study of bardoxolone methyl (bardoxolone) in patients with chronic kidney disease (CKD) due to Alport syndrome.

Bardoxolone is an oral, once-daily activator of Nrf2. A transcription factor, Nrf2 induces molecular pathways that help in reducing inflammation. It restores mitochondrial function, reduces oxidative stress and inhibits pro-inflammatory signaling. The investigational candidate has already been granted an Orphan Drug designation by the FDA for the treatment of Alport syndrome and pulmonary arterial hypertension.

The phase 2 CARDINAL study enrolled 30 patients, who received bardoxolone orally, once-daily for two years. The company said that 90% of the patients remain on the study. These patients will be included in the Week 52 withdrawl analysis.

Reata reported that efficacy results show that significant increases in kidney function are maintained at week 36. The efficacy was measured by estimated glomerular filtration rate (eGFR). At week 36, the mean improvement from baseline in eGFR was 11.3 mL/min/1.73 m2 (n=27; p<0.0000001). This is not significantly different than the change observed at Week 12.

Alport syndrome is a rare disease, affecting an estimated 30,000 to 60,000 people in the U.S. alone, according to data from the Alport Syndrome Foundation.

Reata has a separate phase 3 study with bardoxolone. The phase 3 CATALYST study is evaluating bardoxolone as a treatment of connective tissue disease associated pulmonary arterial hypertension.

Reata shares are down nearly 26% this year. The company ended 2017 with $129.78 million in cash on its balance sheet. The company’s current cash position represents nearly 25% of market capitalization. With two late-stage programs, we believe RETA is worth a look based on current valuation.

Stocks in News: Analysis of ASMB

Assembly Biosciences (ASMB) announced

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