Korean biopharmaceutical company ViroMed’s US division VM BioPharma has begun dosing patients with VM202 in a Phase III clinical trial to treat non-healing diabetic foot ulcers (NHU) and associated peripheral artery disease (PAD).
VM202 is a gene therapy designed to produce hepatocyte growth factor (HGF) protein for induction of angiogenesis, and act as a neurotrophic factor for new microvasculature formation and nerve cell regeneration.
The double-blind, randomised, placebo-controlled, multi-centre Phase III trial will compare the safety and efficacy of VM202 with that of placebo in 300 diabetic foot ulcer and concomitant PAD patients, who will be provided with wound care during the treatment period.
ViroMed chief scientific officer Dr Sunyoung Kim said: "This milestone marks the start of the second Phase III study for VM202, the first being a pivotal trial for painful diabetic peripheral neuropathy.
"There have been numerous efforts to treat foot ulcers, mostly involving complex wound dressings; VM202 stands to alter the lower leg's ischemic environment, one of the critical causes of this condition, and these pivotal data will help us better understand the potential of this novel approach that could improve the quality of life for the millions of patients who suffer from this debilitating condition."
The trial’s primary clinical efficacy outcome is the proportion of subjects with confirmed target wound closure at the four-month follow-up, while secondary endpoints include ankle-brachial index and toe-brachial index changes.
In a previous Phase II trial with critical limb ischemia patients, VM202 had demonstrated a statistically significant rate of complete wound closure and wound improvement by the 12-month follow-up.