Aria presents positive in vivo data on lead IPF treatment candidate

abstract of data

Aria Pharmaceuticals reported that its lead candidate for treating idiopathic pulmonary fibrosis (IPF), TXR-1002, demonstrated significant efficacy in new preclinical research for the potential treatment of IPF.

This is the third preclinical study to validate the efficacy and safety of TXR-1002. Two previous studies evaluated TXR-1002 using a bleomycin-induced (BLM) IPF mouse model, the current best practice for IPF preclinical research, and demonstrated a significant decrease in fibrosis and lung collagen staining compared nintedanib, a standard of care. Aria completed a third study in therapeutic treatment mode using a BLM-induced model in male Sprague Dawley rats, which have more complex airway anatomy than that of a traditional mouse, helping to further support the efficacy of TXR-1002's novel mechanism of action. 

"This is our third robust preclinical study for TXR-1002 that showed positive results and by utilizing a more advanced rat model. We are confident in the promise of this treatment as a viable candidate for clinical research," said said Anjali Pandey, PhD, Aria senior vice president of nonclinical R&D and chemistry.  

IPF is a chronic, age-associated interstitial lung disease characterized by progressive and irreversible fibrosis. It affects more than 3 million people worldwide. Though IPF's cause is still unknown, recent data suggest that IPF prevalence is increasing.

"People suffering from IPF need new and novel treatments because while today's treatments slow disease progression, they do not stop it and are associated with a high rate of discontinuation," said Martin Kolb, MD, PhD, director of the Division of Respirology and Jack Gauldie Boehringer Ingelheim Chair in Interstitial Lung Disease, Department of Medicine at McMaster University. "The incidence and burden of IPF are increasing globally, so discovering and developing new treatments needs to be a priority."

The efficacy of TXR-1002 was assessed in a dose response curve mode at 3, 10, 30 and 100 mg/kg once a day dosing in BLM-induced IPF in male Sprague Dawley rats. The study design included a placebo group, a BLM-induced IPF disease control group, four groups of a TXR-1002 treatment arm and a ninteanib treatment group. Following bleomycin administration, the absolute lung weight and hydroxyproline levels were significantly increased and histopathology data showed both Ashcroft score (measure of lung fibrosis) and collagen significantly increased in the BLM-induced IPF disease control group.

TXR-1002 at 10, 30 and 100 mg/kg once a day administered orally significantly decreased absolute lung weight and hydroxyproline levels as compared to the disease control group. Treatment with TXR-1002 at 10, 30, 100 mg/kg in lung histopathology demonstrated significantly decreased fibrosis score and collagen similar to the nintedanib treatment group at 60 mg/kg.

Full study results can be found at www.ariapharmaceuticals.com.

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