Martin Pharmaceuticals Announces Presentation of Positive Results from the DREAM Study and the Allowance of a Key Patent for its Innovative Ascites Treatment

NEW YORK, Nov. 15, 2024 /PRNewswire/ -- Martin Pharmaceuticals, a clinical-stage pharmaceutical company targeting complications of advanced liver disease, today announced that results from its DREAM study will be presented 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. The company also announced the allowance of a key U.S. 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 include:

Safety: Docarpamine was well-tolerated, with only one patient discontinuing due to a potentially drug-related adverse event.

Efficacy: Patients experienced significant reductions in total ascites volume (53%, p=0.01) and frequency of LVP procedures (44%, p=0.01) post-treatment.

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.

Dr. James O'Beirne, a consultant hepatologist at Sunshine Coast University Hospital and Professor of Hepatology at the University of the Sunshine Coast in Australia, will present the DREAM findings during a poster session on Monday, November 18 (Poster #4108).

The U.S. Patent and Trademark Office (USPTO) recently allowed a Martin Pharmaceuticals patent application with claims that include "A method of treating a patient with ascites, comprising administering to said patient a therapeutically effective amount of docarpamine, wherein said therapeutically effective amount is greater than 2,250 mg per day." This patent, the first for CIQUAAX, establishes the company's intellectual property portfolio and provides exclusivity through November 2040, excluding any extensions.

ABOUT ASCITES

Ascites is the accumulation of fluid in the peritoneal cavity, caused by liver cirrhosis, cancer, infections, or other conditions. It can lead to abdominal distension, discomfort, and reduced mobility. Treatments range from dietary changes and diuretics to invasive procedures like paracentesis or surgical shunt placement.

ABOUT MARTIN PHARMACEUTICALS

Martin Pharmaceuticals, based in New York, is dedicated to helping patients with refractory ascites lead longer and more productive lives. Its lead drug candidate, CIQUAAX^®, is at the forefront of innovation in managing complications from advanced liver disease.

SOURCE Martin Pharmaceuticals