Organovo Data Presented at Digestive Disease Week (DDW2024) Demonstrating Potential for FXR314 as Combination Therapy with Tofacitinib for Inflammatory Bowel Disease

SAN DIEGO, May 21, 2024 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (Nasdaq:ONVO), a clinical stage biotechnology company focused on developing novel treatment approaches in inflammatory bowel disease (IBD) including ulcerative colitis, today announces data from a poster presented at Digestive Disease Week (DDW2024) demonstrating the potential of the Company’s lead clinical-stage compound, FXR314, in combination with tofacitinib for treating inflammatory bowel disease (IBD) using 3D models and preclinical models. DDW2024 is being held in Washington, D.C. May 18-21, 2024.

The poster, titled, “Combination therapy of the FXR agonist FXR314 with tofacitinib in models of inflammatory bowel disease” was presented on Saturday May 18, 2024, in the session “Translational application of intestinal stem cells and organoid models”.

“The study highlights the synergistic benefits of combining the Company’s non-steroidal, non-bile acid FXR agonist with the JAK inhibitor tofacitinib, supporting the notion of FXR314 as both a monotherapy and as part of a combination approach in IBD”, said Dr. Fabrice Piu, Vice President of Research and Development. Key findings showed that FXR314 and tofacitinib improved various measures of intestinal barrier function, inflammation, and fibrosis at optimal concentrations. Further, when combined at sub-efficacious concentrations, FXR314 and tofacitinib combined resulted in further improvements. In addition, FXR314 alone improved measures of colon health and colon histopathology similarly to approved IBD therapies tofacitinib and IL-12/23 antagonist.

Investigators arrived at these conclusions in two ways. The first used Organovo’s proprietary 3D IBD model in which multiple cell types derived from IBD patients (either Crohn’s disease or ulcerative colitis) are co-cultured. The researchers evaluated target engagement, epithelial barrier integrity, inflammation, and fibrosis in the 3D IBD model using a variety of functional assays. The other approach made use of the adoptive T-Cell transfer model, a well-accepted and predictive preclinical model of colitis, where the effects of combining FXR314 and tofacitinib were evaluated in the treatment paradigm.