Helixmith : Announces VM202 (Engensis®) Presentation at New York Academy of Sciences “Advances in Pai…

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Dr. John A. Kessler of Northwestern University will present "New Concept for Neuropathic Pain Relief with Regenerative Medicine Potential Based on Plasmid DNA Encoding Human Hepatocyte Growth Factor, VM202: Scientific Basis and Results from Clinical Studies"

La Jolla, CA, May 2, 2022- Helixmith, a gene therapy company based in Seoul, Korea and San Diego, CA, announced today an upcoming presentation on their lead plasmid DNA product, Engensis (VM202) at the NYAS (New York Academy of Sciences) Advances in Pain Meeting on May 3, 2022. Dr. John A.Kessler, professor of neurology at Feinberg School of Medicine, Northwestern University, will discuss the scientific basis for VM202, recent clinical trial data, and Helixmith's ongoing Phase 3 clinical trial for painful diabetic peripheral neuropathy.

VM202 is a new concept regenerative gene medicine that has been developed for neuropathic pain. VM202 is a plasmid DNA product designed to produce two isoforms of Hepatocyte Growth Factor (HGF). Encouraged by efficacy and safety data from Phase 1 and Phase 2 studies for painful diabetic peripheral neuropathy (DPN), Helixmith's first Phase 3 double-blind, placebo-controlled, study was conducted in two parts; one for 9 months (DPN 3-1; N=500 subjects) and the other with a 3-month extension for late-enrolling subjects (DPN 3-1b; N=101) who were followed for a total of 12 months. Two cycles of treatments with VM202 or placebo were administered to the calf muscles of both legs at 3 month-intervals, one at Days 0 and 14 and another at Days 90 and 104. VM202 showed an excellent safety profile.

As discussed in a recent publication (Kessler et al., 2021), operational problems associated with the initial CRO hampered the analysis of the first part of the DPN 3-1 study, but there was no such issue with the DPN 3-1b extension trial that recruited subjects during the last third of the study. Subjects in this double-bind placebo-controlled extension study showed significant and high levels of pain reduction at 6, 9, and 12 months (p<0.05 at all points). The magnitude of pain reduction was even greater in subjects not receiving pregabalin and/or gabapentin, which was a preplanned analysis based on stratification criteria to recruit subjects who either were or were not continuing use of gabapentinoids as part of standard of care. The data showed that the analgesic effect of VM202 was maintained for more than 8 months without additional VM202 treatments beyond Day 104. Taken together with preclinical data showing that VM202 produces restoration of damaged nerves and blood vessels, VM202 appears to provide a fundamentally new treatment method for patients with DPN by regenerating damaged nerves.

Based on cumulative evidence of efficacy and safety from the Phase 3-1b study and earlier clinical studies, Helixmith is currently conducting a second Phase 3 clinical trial in DPN subjects with assessments of efficacy and safety for 12 months.

About NYAS Advances in Pain

This 2-day conference will bring together international academic and industry researchers from diverse disciplines that include neuroscience/neurobiology, pharmacology, physiology, genetics/genomics, anesthesiology, psychology, and more, to explore the novel mechanisms underlining pain conditions and recent diagnostic/treatment progress. The conference features plenary lectures, poster presentations, and keynotes addresses by David Bennet of Oxford University and by Nobel Prize laureate David Julius of the University of California San Francisco who was awarded the 2021 Nobel prize in Physiology or Medicine for his pioneering work on pain receptors.

About Painful Diabetic Peripheral Neuropathy

Painful DPN is a common and debilitating complication of diabetes mellitus that has a profound negative impact on quality of life, sleep, and mood. Current therapies are palliative and do not target the mechanisms underlying painful DPN. Moreover, symptomatic relief is often limited, and many patients with painful DPN still use opioids.

About Helixmith

Helixmith is a clinical-stage gene therapy company headquartered in Seoul, Korea, developing new and innovative biopharmaceuticals to address previously untreated diseases, and is listed on the KOSDAQ. The company has an extensive gene therapy pipeline, including a CAR-T program targeting several different types of solid tumors and an AAV vector program targeting neuromuscular diseases. Engensis (VM202), the most advanced pipeline candidate, is a plasmid DNA therapy being studied for painful diabetic peripheral neuropathy, diabetic foot ulcers, claudication, amyotrophic lateral sclerosis, coronary artery disease, and Charcot-Marie-Tooth disease.

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