Azora Therapeutics Announces the Publication of Positive Phase 1b Study Results in Treatment-Refractory Ulcerative Colitis
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Los Angeles CA - January 3, 2022 - Azora Therapeutics Inc., a biopharmaceutical company focused on developing treatments for serious inflammatory diseases, announces the publication of Phase 1b study results in patients with treatment-refractory ulcerative colitis in BMJ Open Gastroenterology.
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The manuscript, titled “Treatment-refractory ulcerative colitis responsive to indigo naturalis” was published online in the December 30, 2021 BMJ Open Gastroenterology.
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Results from the phase 1b open-label trial, conducted at Stanford University, showed that 10/11 patients with treatment-refractory ulcerative colitis, including some recommended for colectomy (surgical removal of the colon), met the primary endpoint of clinical response after 8 weeks of treatment with oral indigo naturalis. All study patients experienced improved endoscopic severity and quality of life. The therapy was well tolerated with no discontinuations due to adverse events. In addition, all evaluable patients demonstrated a dramatic reduction in colon inflammation via a biomarker (fecal calprotectin). Colon biopsies at week 8 demonstrated a significant increase (greater than 10,000-fold) in aryl hydrocarbon receptor activation as evaluated by CYP1A1 mRNA expression.
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Indigo naturalis is a botanical extract that contains molecules that are agonists of the aryl hydrocarbon receptor. This is the same mechanism of action as Azora's AT177, an oral treatment currently in development.
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“We are enthusiastic with the positive results of the study and the solid foundation we believe it may provide for conducting further trials to evaluate options for patients with treatment-refractory ulcerative colitis” added Berkeley N Limketkai, MD, PhD, the lead investigator of the study and currently Director of Inflammatory Bowel Disease Clinical Research at University of California at Los Angeles (UCLA).
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The study was conducted with funding provided by SPARK at Stanford, Weston Havens Foundation, and Azora Therapeutics.
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About Azora
Azora Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing treatments for serious inflammatory diseases. The company was spun out of Stanford University after being incubated in the translational medicine SPARK program. Azora owns the worldwide royalty-free rights to its technology, which is based on the development of potential best-in-class and first-in-class oral and topical agonists of the aryl hydrocarbon receptor. More information on Azora and its pipeline can be found on the company's website at www.AzoraTherapeutics.com.