Martin Pharmaceuticals Licenses Docarpamine Data To Mitsubishi Tanabe

Martin Pharmaceuticals is a clinical-stage company focused on developing CIQUAAX® (docarpamine) to treat complications from advanced liver disease. The firm has announced a licensing agreement with Mitsubishi Tanabe Pharma Corporation (MTPC). This deal grants MTPC exclusive access to docarpamine’s toxicology, preclinical, clinical safety, and pharmacokinetics data related to gastrointestinal conditions, such as ascites, for markets outside Japan and China. In exchange, MTPC will receive an undisclosed upfront payment as well as additional milestone payments and royalties.

Sven Jacobson, Chief Executive Officer of Martin Pharmaceuticals, said in a statement, “This license agreement with MTPC, a global leader in the pharmaceutical industry, will help us rapidly advance the development of CIQUAAX. We are grateful to be able to access MTPC’s years of experience with docarpamine. We 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 agreement follows recent results from the DREAM study, a Phase 2a open-label trial evaluating docarpamine's safety and effectiveness in patients with refractory ascites, a severe complication of liver cirrhosis. The study enrolled 16 patients who required regular large-volume paracentesis (LVP). Participants were treated with either a low (750 mg TID) or high (1500 mg TID) dose of docarpamine for up to 90 days.

Key findings included:

• Safety: Docarpamine was generally well-tolerated, with only one patient discontinuing due to a possible drug-related side effect.

• Efficacy: Significant reductions were seen in total ascites volume (53%, p=0.01) and the frequency of LVP procedures (44%, p=0.01) post-treatment.

These results suggest that docarpamine could help delay or reduce the need for invasive paracentesis by managing ascites through neurohumoral effects.

Additionally, the U.S. Patent and Trademark Office (USPTO) has granted Martin Pharmaceuticals a patent that includes “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, marking the first for CIQUAAX, secures intellectual property rights for the company until November 2040, excluding potential extensions.