NEW YORK, Dec. 3, 2024 /PRNewswire/ — Martin Pharmaceuticals, a clinical-stage pharmaceutical company developing CIQUAAX® (docarpamine) for the treatment of complications arising from advanced liver disease, today announced that it has entered into a license agreement with Mitsubishi Tanabe Pharma Corporation (MTPC) for exclusive access to docarpamine-related toxicology, preclinical, clinical safety, and pharmacokinetics data in the field of gastrointestinal conditions, including ascites, for use outside of Japan and China. Under the terms of the agreement, MTPC will receive an undisclosed upfront payment and additional milestones and royalties.
“This license agreement with MTPC, a global leader in the pharmaceutical industry, will help us rapidly advance the development of CIQUAAX,” said Sven Jacobson, Chief Executive Officer of Martin Pharmaceuticals. “We are grateful to be able to access MTPC’s years of experience with docarpamine and are excited by the potential of CIQUAAX given the significant unmet need for a safe and effective therapy for patients with decompensated chronic liver disease.”
This announcement follows recent findings from the DREAM study, which 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, who was on the high dose, 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.
In addition, 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 CHRONIC LIVER DISEASE
Chronic liver disease is a progressive deterioration of liver function. Inflammation of the liver (hepatitis) that persists can lead to destruction of liver tissue, and eventually to severe and permanent cirrhosis. People with cirrhosis are at risk of developing end-stage liver failure or liver cancer. Cirrhosis is relatively common and is a significant cause of hospitalization and death, especially after middle age. In the United States, cirrhosis affects about 0.25% of all adults and about 0.50% of adults between the ages of 45 and 54. About 26,000 deaths in the United States are attributed to cirrhosis, and rates are rising.
ABOUT ASCITES
Ascites is a common and significant complication of chronic liver disease, resulting from portal hypertension, hypoalbuminemia, and fluid retention due to impaired liver function. 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. In the United States, approximately 60% of patients with cirrhosis develop ascites within 10 years of their diagnosis.
ABOUT MITSUBISHI TANABE PHARMA CORPORATION
Mitsubishi Tanabe Pharma Corporation (MTPC), the pharma arm of Mitsubishi Chemical Group (MCG), is one of the oldest pharmaceutical companies in the world, founded in 1678, and focusing on ethical pharmaceuticals. MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan’s pharmaceutical industry. MTPC sets the MISSION of “Creating hope for all facing illness”. To that end, MTPC is working on the disease areas of central nervous system, immuno-inflammation, diabetes and kidney, and cancer. MTPC is focusing on “precision medicine” to provide drugs with high treatment satisfaction by identifying patient populations with high potential for efficacy and safety. In addition, MTPC is working to develop “around the pill solutions” to address specific patient concerns based on therapeutic medicine, including prevention of diseases, pre-symptomatic disease care, prevention of aggravation and prognosis. For more information, go to https://www.mt-pharma.co.jp/e/
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 chronic liver disease.
SOURCE Martin Pharmaceuticals
