Clinical-stage pharmaceutical company Martin Pharmaceuticals announced on Friday the results from its DREAM study at the 75th Annual Liver Meeting, hosted by the American Association for the Study of Liver Diseases (AASLD), in San Diego, California, from November 15–19, 2024.
Martin Pharmaceuticals also revealed the allowance of a key US patent covering the treatment of ascites with its drug CIQUAAX (oral docarpamine).
The DREAM study evaluated the safety and efficacy of docarpamine in patients with refractory ascites, a severe complication of liver cirrhosis. The Phase 2a open-label trial enrolled 16 patients with refractory ascites requiring regular large-volume paracentesis (LVP). Patients received either a low dose (750 mg TID) or a high dose (1500 mg TID) of docarpamine for up to 90 days.
Key findings from the study showed that from a safety perspective, Docarpamine was well-tolerated, with only one patient discontinuing due to a potentially drug-related adverse event. Regarding efficacy: Patients experienced significant reductions in total ascites volume (53%, p=0.01) and frequency of LVP procedures (44%, p=0.01) post-treatment.
Martin Pharmaceuticals says that these results suggest that docarpamine has the potential to delay or reduce the need for invasive paracentesis procedures by leveraging neurohumoral effects to manage ascites.
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