Nextgen (part of Artgen Biotechgroup, MOEX: ABIO) received MoH authorization to conduct phase III clinical study of Neovasculgen® gene therapy drug for treatment of the diabetic foot disease (DFD).
Results of phase I and II clinical studies to assess the safety and efficiency of the drug confirmed that injection of Neovasculgen® into involved tissues speeds up healing of ulcerous defects and enhances tissue regeneration in DFD patients.
In phase III clinical studies of the drug, its efficiency in DFD patient treatment will be comprehensively assessed. Protocol: “Prospective, double-blind, multicenter, placebo-controlled, randomized, comparative clinical study to assess the safety and efficiency of Neovasculgen in diabetic foot disease subjects” (MoH RF Resolution No. 70 dd February 11, 2025).
Sergey Vladimirovich Dale, Nextgen General Director: “The study with 188 subjects will be conducted at 5 clinical centers in Moscow, Voronezh, Novosibirsk and Stavropol and will last to March 2027.”
If phase III clinical trials are successful, Nextgen will launch the drug at the market for diabetic foot disease treatment.
Over 130 thousand new diabetes mellitus cases are diagnosed in Russia annually. According to the Federal registry of diabetes mellitus patients, 4.9 mio. diabetes mellitus patients were registered in Russia as of January 1, 2022. According to an extensive Russian epidemiological research, the actual number of diabetes mellitus patients in Russia is at least 10 mio. people. The Russian market of drugs that help maintain and enhance health condition in diabetic foot disease patients is currently estimated at 1.7B rubles.
The diabetic foot disease is one of the most common diabetes mellitus complications and the reason of non-traumatic lower limb amputations in 75% of cases in the world. It includes pathological changes in nerve endings, foot vessels and capillaries leading to ulceration and necrosis of tissues. The disease is complicated by infection of deeper structures leading to gangrene requiring amputation. The risk of diabetic foot disease in diabetes mellitus patients is from 19 to 45% depending on the underlying disease severity. About 30% of patients are subject to repeated amputation after the initial one and post-amputation mortality is 50–70%.
Neovasculgen® is the world first approved gene therapy drug used in practical healthcare to treat ischemia of lower extremities, included into the EML list, national recommendations, federal clinical-statistical groups, Moscow OMI programme. The drug gave start top a new medicine area — therapeutic angiogenesis (therapeutic vessel growth). As the effect of drug is based on activation of microvessel tree growth, it has a potential to treat a number of diseases, where it is needed to make the vasculature denser, including diabetic foot disease.
Nextgen JSC is a resident of Medtech, Lomonosov cluster of Innovation Science and Technology Center of Moscow State University Vorobyovy Gory. The company deals with the development and implementation of gene therapy drug.