Martin Pharmaceuticals, a clinical-stage pharmaceutical company developing CIQUAAX® (docarpamine) for the treatment of complications arising from advanced liver disease, 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.
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