Treating Disruptive Symptom’s in Crohn’s Patients: Q&A with Mark Genovese, MD

Mark Genovese, MD
Senior vice president
Lilly Immunology Development

The European Medicines Agency’s Committee for Medicinal Products for Human Use recently issued a positive opinion for the use of Omvoh for the treatment of moderate to severe Crohn’s in adults. Mark Genovese, MD, senior vice president at Lilly Immunology Development, spoke with Pharmaceutical Executive about the importance of developing medicines that treat disruptive symptoms of chronic conditions.

Pharmaceutical Executive: How urgent is the need for a treatment for bowel urgency in Crohn’s disease patients?

Mark Genovese: Crohn’s disease is a chronic, inflammatory bowel disease associated with progressive bowel damage, disability, and decreased health-related quality of life. Disruptive symptoms of Crohn’s disease, such as abdominal pain, frequent bowel movements and bowel urgency, can interfere with all aspects of life.

Despite continued advances, a majority of patients living with moderately to severely active Crohn’s disease do not achieve remission with current therapies or cannot maintain it long-term. Many patients are still seeking treatment options that can address these difficult-to-manage symptoms and provide lasting results.

Based on data from the Phase 3 VIVID-1 trial, Omvoh treatment presents the opportunity for comprehensive disease control for people living with moderately to severely active Crohn’s disease, including visible healing of the intestinal lining, histologic evidence of improvement, and extensive control of disruptive symptoms.

Additionally, among those who achieved clinical remission and endoscopic response at one year, nearly 90% of patients maintained clinical remission with two years of continuous Omvoh treatment in open-label extension.

PE: What other symptoms of Crohn’s still need new treatment options?
Genovese: People living with Crohn’s disease can suffer from a number of highly disruptive symptoms such as abdominal pain, frequent bowel movements, and bowel urgency. 

The VIVID-1 trial showed that Omvoh may help patients with or without prior biologic failure get relief from disruptive symptoms and achieve remission of inflammation, defined by visible healing of the intestinal lining as well as the underlying mucosal wall.

In the U.S., the FDA recently approved Omvoh for the treatment of moderately to severely active Crohn’s disease in adults. We look forward to a decision from the European Commission regarding approval in Europe soon, following the recent positive opinion by the CHMP. The U.S. approval and positive CHMP opinion reflect our commitment to help people with immune system conditions relieve disease burden and sustain long-standing remission.

PE: Omvoh was first approved for treatment of ulcerative colitis. When was it discovered it could also treat Crohn’s symptoms?
Genovese: Omvoh selectively targets the p19 subunit of IL-23 and inhibits the IL-23 pathway. Inflammation due to over-activation of the IL-23 pathway plays a critical role in the pathogenesis of inflammatory bowel diseases, which includes both ulcerative colitis (UC) and Crohn’s disease. Further, for more than a decade, research has indicated medicines targeting the IL-23 pathway may be effective for the treatment of both UC and Crohn’s disease.

In Crohn’s disease, Lilly shared positive topline results from our pivotal VIVID-1 trial in late 2023.

PE: Are there any other indications under investigation for Omvoh?
Genovese: Our focuses in Immunology include the continued advancement of current monoclonal antibodies, next generation modalities and targeted expansion of the small-molecule pipeline, including oral medicines.

Lilly has additional ongoing trials to evaluate the efficacy and safety of Omvoh in other populations with UC and Crohn’s disease, including studies in pediatric patients, a long-term study in adults with UC and a Phase 4 real-world evidence study to evaluate Omvoh’s impact in patients with UC in clinical practice.

In addition, Lilly is also evaluating Omvoh with an open-label UC trial studying two new endpoints in the assessment of bowel urgency with frequency and deferral time, both of which impact the quality of life for patients.

Lilly also has a combination study in UC with Omvoh and eltrekibart, a humanized monoclonal antibody that binds to the seven ligands that signal through the CXCR1 and CXCR2 chemokine receptors involved in neutrophil movement to sites of inflammation.