Drug Farm has dosed the first subject in part three of its Phase I clinical trial evaluating DF-006 as a single agent and along with standard-of-care nucleos(t)side reverse transcriptase inhibitors in virologically suppressed and treatment-naive patients with chronic hepatitis B (CHB) infection.
The placebo-controlled, randomised, double-blind study is designed to assess the pharmacokinetics, tolerability and safety of ALPK1 agonist DF-006 in these patients.
Subjects who have CHB infection, as documented by serum HBsAg-positive at least six months prior to screening, are included in the study. They will receive multiple doses orally.
The company intends to enrol patients from several countries including China, Taiwan, New Zealand and Korea.
The trial will measure the levels of DF-006 and its related compounds in the blood over time following multiple doses of the formulation.
It will also assess the anti-viral effects of DF-006 as well as see if the therapeutic is safe and well-tolerated in these subjects.
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Drug Farm chief medical officer Dr Jeysen Yogaratnam said: “DF-006 is a first-in-class innate immunity modulator that has demonstrated potent anti-hepatitis B virus responses in in vitro and in vivo preclinical studies as described in our recent publication in hepatology.
“We will be evaluating DF-006 in various chronic hepatitis B patient subpopulations in our global multicentre, placebo-controlled randomised study at sites in Europe and Asia, including China.”
The company claims that DF-006 stimulates local innate immunity in the liver.
It is also engaged in developing therapeutics for treating heart and kidney diseases, as well as retinal dystrophy, optic nerve edema, splenomegaly, anhidrosis and headache (ROSAH) syndrome.