Organovo Holdings, Inc. (Nasdaq:ONVO) has appointed Norman Staskey as its new Chief Financial Officer, effective January 6, 2025. Staskey's arrival coincides with Organovo's ongoing clinical trials for inflammatory bowel disease (IBD) and promising Phase 2 results for its lead drug, FXR314, in Metabolic Dysfunction-Associated Steatohepatitis (MASH).
Staskey's Background and Role
Norman Staskey brings over 25 years of experience in capital market and M&A transactions. Prior to joining Organovo, he worked with Danforth Advisors and held a Managing Director position at EY, where he advised on significant M&A deals, including the Dell-EMC merger. Keith Murphy, Executive Chairman of Organovo, expressed enthusiasm about Staskey's appointment, stating, "With his extensive experience, including focus in the biotech industry, and his strong background in M&A transactions, he brings a skill set that opens up new possibilities for Organovo in 2025."
FXR314 in MASH: Phase 2 Results
Organovo's lead drug, FXR314, has shown promise in treating liver fibrosis associated with MASH. At the Liver Meeting in November 2024, Dr. Eric Lawitz presented detailed results from a 16-week, randomized, placebo-controlled, multi-center Phase 2 study. The study, involving 214 patients, demonstrated a statistically significant reduction in liver fat content from baseline in patients receiving FXR314 compared to placebo. Furthermore, FXR314 exhibited a favorable safety profile, with significantly lower pruritus rates compared to other FXR agonists.
FXR314 in IBD: Preclinical and Clinical Potential
In 2024, Organovo presented data at the Crohn’s and Colitis Congress and Digestive Disease Week, highlighting FXR314's potential in IBD. Studies using 3D human cellular models of Crohn’s disease and ulcerative colitis showed that FXR314 improved epithelial barrier function and reduced fibrotic activity in ulcerative colitis. Additional studies indicated a synergistic therapeutic benefit when FXR314 was combined with a Janus kinase (JAK) inhibitor.
Future Clinical Development
Organovo anticipates initiating a Phase 2 study to evaluate the effectiveness of FXR314 in patients with moderate to severe ulcerative colitis. The company believes that FXR314 has the potential to be developed as a monotherapy or as part of a combination therapy for both ulcerative colitis and Crohn’s disease, addressing a significant unmet need in IBD treatment.
