In November 2023, the field of gastroenterology saw several notable developments:
- FDA Approval for Erosive Esophagitis Treatment: The FDA approved Phathom Pharmaceuticals’ vonoprazan for treating all grades of erosive esophagitis (GERD). Vonoprazan, an oral small molecule potassium-competitive acid blocker, has shown potential in providing effective acid suppression. This approval was based on the positive results from the phase 3 PHALCON-EE study, which enrolled 1,024 patients and demonstrated vonoprazan’s effectiveness compared to the PPI lansoprazole.
- Discontinuation of Phase 3 Ulcerative Colitis Program: InDex Pharmaceuticals announced the discontinuation of their phase 3 CONCLUDE program for cobitolimod in ulcerative colitis. This decision followed a planned dose selection analysis by an independent Data Monitoring Committee, which indicated that cobitolimod was unlikely to meet the primary endpoint of clinical remission at week 6.
- Clostridioides difficile Testing and Risk Factors: A retrospective cohort study at three hospitals in North Carolina focused on racial disparities in Clostridioides difficile infection (CDI) testing. The study found that White patients received more CDI tests than Black and non-White non-Black patients, despite similar positivity rates. Additionally, a pharmacovigilance study linked commonly administered antibiotics to the risk of CDI and related adverse drug reactions, highlighting the need for careful antibiotic use in hospitals.
These developments in gastroenterology reflect ongoing efforts to improve treatments for digestive diseases and address disparities and risks in patient care. The FDA’s approval of new treatments and the careful evaluation of ongoing clinical programs underscore the dynamic nature of research and treatment in this field.