VM BioPharma, the United States division of ViroMed Co., Ltd. in Seoul, Korea, yesterday announced the first patient was dosed in the recently initiated Phase 3 clinical study evaluating VM202, a proprietary DNA based biopharmaceutical, in patients with painful diabetic peripheral neuropathy (DPN). This is the first pivotal gene therapy trial specifically targeting the most common cause of severe neuropathy, and follows the successful completion of a Phase 2 trial conducted at Northwestern University and multinational sites in the U.S. and Korea.
“The initiation of a pivotal clinical trial for VM202 is incredibly exciting, because we observed in the Phase 2 trial a rapid and significant reduction in DPN pain, along with signals that VM202 may elicit a disease-modifying effect,” says Jack Kessler, MD, professor of neurology at Northwestern University’s Feinberg School of Medicine and the principal investigator of the Phase 3 study. “Current treatments for DPN are aimed at providing symptom management, and along with a high rate of patient failure, do not modify the underlying pathology of the condition.”
DPN is a common complication of diabetes in which nerve damage results in sudden and severe pain. VM202 is a plasmid DNA that contains the human hepatocyte growth factor (HGF) gene, which in vivo produces two isoforms of HGF proteins that are naturally found in the human body. HGF is a growth factor that induces angiogenesis and acts as a neurotrophic factor to peripheral nervous system. After VM202 is injected into a patient’s muscle, it is taken up by a cell and produces the HGF proteins, which are then released from the cell and may induce new blood vessel formation by activating various signaling pathways. In this way, VM202 is believed to promote microvasculature and regenerate nerve cells, providing clinical benefit to patients with DPN.
“This milestone marks an exciting time for VM BioPharma, and we are pleased to be a part of such revolutionary research taking place in diabetic peripheral neuropathy, and other disease areas with high unmet needs,” says Sunyoung Kim, chief scientific officer of ViroMed Co., Ltd. “This is the first Phase 3 study to evaluate the use of gene therapy as a way to nourish and recover damaged nerve cells, and we are looking forward to providing pivotal data that 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.”
Study Design
The nine month, Phase 3, double-blind, randomized, placebo-controlled, multicenter study is designed to assess the safety and efficacy of VM202 in 477 adult patients with painful diabetic peripheral neuropathy. Patients will be randomized in a 2:1 ratio to either VM202 (n=318) or placebo (n=159) and will be stratified by current use of gabapentin and/or pregabalin. The primary clinical efficacy outcome will be the change in average pain score from baseline to the 3 month follow-up visit, as well as a 50% responder rate. For more information on this study, please visit ClinicalTrials.gov and reference Identifier NCT02427464.
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