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Monday, September 27, 2021 4:54:44 PM
In January 2021, Alfasigma notified the Company that the Phase 1 study for the treatment of UP/UPS using Brilacidin in a proprietary Alfasigma formulation successfully completed dosing per protocol; an extra treatment cohort was subsequently added by amendment and commenced in 2Q 2021. In April 2021, the Company was notified that a Phase 2 multinational clinical trial for UP/UPS is planned to commence 4Q 2021, and Alfasigma has ordered Brilacidin from the Company for use in this study. Due to a delay at the manufacturing vendor, delivery of drug substance to Alfasigma has moved out (mid 4Q2021), and the subsequent drug product manufacturing time will likely push any clinical trial start into 2022.
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