4. Impact and future plans
(1) VM202 is a biopharmaceutical developed exclusively with Korea’s technology. With the safety and efficacy results confirmed through this phase II study, we were able to confirm the potential of VM202 to be developed as a treatment to fundamentally treat diseases.
(2) After 12 months follow-up ViroMed observed clinically and statistically meaningful and consistent improvements in all efficacy parameters (ulcer healing, TcPO2, ABI, and rest pain (VAS)) compared to placebo and baseline. For safety, there were no directly drug-related adverse effects
(3) Based on these results, ViroMed submitted VM202-PAD phase II final report to US FDA in March 19th, 2014. US FDA reviewed the final report for 1 month after submission and did not raise any objections regarding safety and efficacy results.
(4) ViroMed’s consultant in the US recommended detailed preparation for next clinical study (phase III) since the final report submitted to the US FDA met FDA’s criteria.
2) Future plans: We are planning to publish VM202-PAD’s phase II study results in an international scientific journal. We also plan to hold meetings with US FDA to discuss and determine detailed contents for next clinical development.