September 8, 2021, Singapore – Evive Biotech (Evive), an innovative global biopharmaceutical company developing novel biological therapeutics, announced today that the National Medical Products Administration (NMPA) has approved the investigational new drug (IND) application for a multi-center, randomized, double-blinded, placebo controlled, phase II clinical study of F-652 (IL-22:IgG2 Fusion Protein) in combination with basic treatment in patients with acute-on-chronic liver failure (ACLF). This marks the first ACLF biological therapy IND application approval in China.

The study anticipates enrolling up to four cohorts with 60-80 patients across 7 sites in China to evaluate the efficacy and safety of F-652 for the treatment of ACLF as well as the pharmacokinetic properties of F-652 in patients with ACLF.

ACLF is a high mortality disease with a 30-day fatality rate of over 30% and no effective standard of care. Dr. Jubo Liu, Evive Biotech’s CEO commented, “As there is no effective treatment for ACLF currently, we see a significant need to develop a new standard of care for patients. The acceptance of the IND application from the NMPA for Evive Biotech’s F-652 represents a significant milestone in the journey to offering a promising drug to treat patients with ACLF.”

“We are eager to explore the role that F-652 can play for the treatment of ACLF,” said Dr. Xie Qing, Chief of Shanghai Ruijin Hospital Infection Division. She added, “F-652 has been shown to promote liver regeneration and improve patient prognosis in previous data. The candidate drug reveals a new strategy for clinical treatment and has the potential to enable access to treatment options other than liver transplantation for patients with ACLF.”

About ACLF

Acute-on-chronic liver failure(ACLF) is a syndrome with acute jaundice and coagulation dysfunction as the manifestation of liver failure caused by various inducements on the basis of chronic liver disease, which can be complicated with hepatic encephalopathy, ascites, electrolyte disorder, infection, hepatorenal syndrome, hepatopulmonary syndrome and other complications, as well as extrahepatic organ failure. According to the consensus recommendations of Asian Pacific Association for the Study of the Liver (APASL) in 2019, ACLF is an acute hepatic insult manifesting as jaundice (serum bilirubin ≥ 5 mg/dL (85 micromol/L) and coagulopathy (INR ≥ 1.5 or prothrombin activity < 40%) complicated within 4 weeks by clinical ascites and/or encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease/cirrhosis, and is associated with a high 28-day mortality.

About F-652

F-652 is a novel dimeric IL-22 fusion protein currently in multiple development programs for the treatment of inflammatory diseases.  IL-22 has been shown to have natural growth promoting activity in epithelial cells to combat organ injuries induced by a variety of causes and eventual fatal organ failures.  Published literature and Evive’s completed clinical trials have presented F-652 with opportunities to treat multiple diseases, some of which Evive is actively pursuing or developing, including acute graft vs host disease (aGvHD), acute alcoholic hepatitis and COVID-19.  F-652 has been postulated as a potential therapeutic candidate for treatment of patients with ACLF.

About Evive Biotech

Evive Biotech is a global biologics company with Asian roots, developing a portfolio of novel biological therapies for patients worldwide. We leverage our proprietary technology platforms to advance a series of innovative drug candidates for oncology and inflammatory disorders. Founded in 2004, we have over 270 employees today with operations in the US, Singapore and China. We adopt a holistic approach to drug development, combining exceptional research and commercialization capabilities with world class in-house regulatory expertise to bring innovative therapies to market quickly and efficiently. Through partnerships with industry, physicians, and regulatory authorities, we develop revolutionary remedies that we believe will make a real and lasting difference to patients and their families worldwide. To learn more about Evive Biotech, visit www.evivebiotech.com.