What is Art-101?
Art-101 is a 2nd generation injectable supercoiled DNA plasmid coding for Vascular Endothelial Growth Factor (VEGF). It is designed to induce blood vessel creation and restore blood flow to the limb, leading to a reduction in pain and risks of cardiovascular events in stages II and III of PAD.
- Stimulates angiogenesis in surrounding tissue via the VEGF-pathway
- Is not genome-altering
- Designed to treat PAD (Stages 2/3) and arrest/reverse disease progression
- Significantly developmentally de-risked due to previous clinical safety data for the
ART-101 is an improved locally injectable therapy designed for enhanced drug half-life for sustained in vivo activity.
ART-101 is based upon Neovasulgen® (1st generation), the first-in-class gene-therapy drug originally developed by HSCI for treatment of Peripheral Arterial Disease (PAD), including Critical Limb Ischemia (CLI). Neovasulgen® is an already approved therapy in Russia and Ukraine with demonstrated safety and efficacy, significantly de-risking the developmental pathway for ART-101.
ART-101 has same mechanism of action and same active molecule as Neovasculgen®, the only difference is a small modification that increases mRNA half-life time. Art-101 is expected to have even better clinical results than Neovasculgen. To date more than 2500 people treated with Neovasculgen® in Russia and no drug-related SAEs have been observed.
Patients who qualify for Neovasculgen® treatment have seen significant increases in their pain-free-walking distance, which is a main efficacy indicator. Patients also reported significant increase of quality of life.
Neovasculgen® (1st generation) clinical highlights: