VGX Pharmaceuticals receives FDA clearance to commence clinical trials of VGX-1027, a novel oral drug with potent anti-inflammatory activity
BLUE BELL, Pa. -- VGX Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) accepted the Investigational New Drug (IND) application for its lead anti-inflammatory compound, VGX-1027. VGX-1027 is an orally active, small molecule compound that has shown preclinical efficacy against various inflammatory diseases including Rheumatoid Arthritis (RA) and Type 1 diabetes (T1D).
VGX-1027 is the first of a new class of immune modulators that inhibits the production of several pro-inflammatory cytokines, which are responsible for the damaging effects of inflammatory diseases. Preclinical studies have shown that VGX-1027 is effective in inhibiting these cytokines in cell cultures. They have also demonstrated the product’s efficacy in animal models for several diseases including RA, T1D, psoriasis, and colitis. Its main mechanism of action is the inhibition of NF-kB and the early transient inhibition of P38 MAP kinase signaling pathways.
Inflammatory diseases including RA, T1D, psoriasis, and colitis represent major medical problems. In the U.S. alone, over 2.7 Million people suffer from rheumatoid arthritis. An additional 1 Million Americans suffer from type 1 diabetes, which can be fatal if untreated.
Several blockbuster therapeutic agents dominate the multi-billion dollar RA drug market. However, all of these agents require injection into a patient’s muscle or skin. VGX-1027 offers a distinct advantage over such products because it can be taken as a once-a-day pill. There are very few treatment options available for T1D patients other than insulin, which requires daily injections.
“VGX looks forward to promptly initiating Phase I clinical trials for VGX-1027, which has several potential advantages over other treatment options," stated Dr. J. Joseph Kim, President and Chief Executive Officer.
VGX will conduct Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) in its Phase I studies on VGX-1027. Upon successful completion, the results from these studies will satisfy FDA requirements to commence two Phase II studies: one for RA patients, to be conducted by VGX Pharmaceuticals, and one for T1D patients, to be conducted by its affiliate, VGX International.