Trial will evaluate DF-006, a first-in-class ALPK1 agonist that stimulates local innate immunity in the liver

GUILFORD, Conn. & SHANGHAI--(BUSINESS WIRE)--Drug Farm, a clinical-stage biopharmaceutical company, announced today that it has dosed the first chronic hepatitis B patient in Part 3 of its Phase 1 clinical trial (ANZCTR Trial ID: ACTRN12621000592842). This trial is evaluating Drug Farm’s first-in-class ALPK1 agonist, DF-006, as a monotherapy and in combination with standard-of-care nucleos(t)side reverse transcriptase inhibitors in treatment-naïve and virologically suppressed patients with chronic hepatitis B infection.

“DF-006 is a first-in-class innate immunity modulator that has demonstrated potent anti-hepatitis B virus (HBV) responses in in vitro and in vivo preclinical studies as described in our recent publication in Hepatology¹,” said Drug Farm’s Chief Medical Officer, Dr. Jeysen Yogaratnam. “We will be evaluating DF-006 in various chronic hepatitis B patient subpopulations in our global multicenter placebo-controlled randomized study at sites in Europe and Asia, including China.”

“DF-006 has demonstrated a good safety and tolerability profile to date following single and multiple ascending dose evaluations in healthy volunteers,” said Prof. Ed Gane, the lead Principal Investigator for this study. “As an oral drug administered once weekly, DF-006 has the potential to be the immunomodulator of choice in combination HBV cure regimens”.

1. Xu C, Fan J, Liu D, Tuerdi A, Chen J, Wei Y, Pan Y, Dang H, Wei X, Yousif AS, Yogaratnam J, Zhou Q, Lichenstein H, Xu T. Alpha-kinase 1 (ALPK1) agonist DF-006 demonstrates potent efficacy in mouse and primary human hepatocyte (PHH) models of hepatitis B. Hepatology. 2023 Jan 1;77(1):275-289. doi: 10.1002/hep.32614.

About Drug Farm

Drug Farm is a private biotechnology company developing innovative treatments targeting innate immunity for hepatitis B, heart and kidney diseases, and ROSAH (retinal dystrophy, optic nerve edema, splenomegaly, anhidrosis and headache) syndrome. Drug Farm's unique IDInVivo platform combines breakthrough technologies in genetics and AI to discover new treatments. IDInVivo technology allows the direct assessment of gene targets in living animals with intact immune systems. Using the IDInVivo platform, Drug Farm has identified novel innate immunity pathways and targets and is now rapidly advancing multiple first-in-class drug candidates into clinical development. For more information please visit: www.drug-farm.com

Contacts

United States:

Henri Lichenstein, Ph.D.

Chief Executive Officer

[email protected]

China:

Tony Xu, Ph.D.

Chief Operating Officer

[email protected]