Expansion of Clinical Trial Sites
The number of active clinical trial sites increased to five, with plans to expand to seven by the end of the year and 11 by next year. The FDA expanded the maximum number of trial sites from 10 to 14.
Progress in NEPHRO CRRT Study
The first patient was enrolled in August, and multiple patients have completed the trial. The company is taking measures to improve enrollment rates and activate additional study sites.
Clinical and Regulatory Advantages
Nafamostat has a 30-year track record of efficacy and safety in Japan and South Korea, minimizing clinical risk. The trial design has been agreed upon with the FDA, and the product candidate has a breakthrough designation, allowing for quicker review and response times.
Financial Support from Main Investor
Main investor Nantahala has expressed continued financing support for the clinical study.