December 3, 2021, Singapore – Evive Biotech, a global biologics company developing novel biologic therapies, today announced the first patient has been dosed in a phase 2 clinical trial of F-652 in adult patients with acute-on-chronic liver failure (ACLF). F-652 is a novel dimeric IL-22 fusion protein currently in multiple development programs for the treatment of diseases with significant unmet medical needs.

“Dosing of the first patient is an important step forward for Evive and, more importantly, for patients with ACLF who are in urgent need for new and effective therapies. Currently for these patients, treatment is limited to steroids or liver transplantation, a major surgery with potential for numerous complications,” said Dr. Jubo Liu, Chief Executive Officer of Evive Biotech. “Data from preclinical and pilot clinical studies showed that F-652 has the potential to mitigate ACLF-related clinical symptoms and to reduce mortality rate. We are committed to unlocking the full potential of F-652 in patients with ACLF.”

“The phase 2 clinical trial is a multi-center, randomized, double-blind, placebo controlled, two-stage study. The first stage is to evaluate the safety, preliminary efficacy, pharmacokinetic (PK) and pharmacodynamics (PD) characteristics of F-652 at three doses in patients with ACLF,” said Dr. Simon Li, Chief Medical Officer of Evive Biotech. “Based on the outcome of the first stage, the second stage will be designed as a pivotal study with adequate patient numbers to demonstrate the efficacy and safety of F-652 in patients with ACLF. This pivotal study may be sufficient for the submission of a marketing approval for F-652 due to the significant unmet medical needs of ACLF. “

For more information on Evive’s F-652 IND Approval for the treatment of ACLF, please click Evive Biotech Announces IND Approval by the NMPA for a Phase II Clinical Study of F-652 in Patients with ACLF – Evive Biotech