Origin, Inc. (formerly Advanced Plasma Therapies, Inc), a Princeton, NJ-based clinical-stage wound care company focused on treatment of Diabetic Foot Ulcers (DFUs) has announced that the first 52 patients have been randomized in the “GENESIS” trial, marking the passing of the halfway enrollment point for the study. The first patient in the study was randomized on March 21, 2017. These patients are being treated in its U.S. dose-ranging Phase IIb "GENESIS" trial. Additionally, all the sites designated for the study have been activated. Origin has developed a proprietary technology to generate and deliver therapeutic quantities of plasma-generated Nitric Oxide (NO) for a wide range of potential human health benefits. The GENESIS trial is designed to demonstrate healing and optimize the treatment regimen for chronic Diabetic Foot Ulcers (DFUs).
“We are excited about the pace of enrollment for the GENESIS trial and the full activation of all our sites, both of which are ahead of schedule. The rate of enrollment is ahead of what we had envisaged and, if maintained, points to an earlier look than anticipated at data from our first controlled US trial,” said Michael Preston, Chairman and CEO of Origin. “The enrollment rate for the GENESIS trial is a clear indication that DFUs represent a critical unmet need for patients with diabetes, a disease that is growing far too rapidly and affecting more than 49 million people in the US and EU alone. Plasma-generated Nitric Oxide has the potential to offer a safe and effective wound closure treatment, particularly for patients with Diabetic Foot Ulcers, where limb amputation is often the outcome. Because DFUs affect as many as 7 million people in the US and EU with diabetes (as high as 15% of the diabetic patient population), we believe that Origin’s first targeted indication represents a large market opportunity.”
GENESIS is a single-blinded 27-week study which will recruit up to 100 patients across 15 clinical sites in the U.S. After a three-week qualification period, patients will be randomized into one of four different dosing regimens or a standard of care (SOC) treatment arm to assess efficacy and safety. Patients will be treated over 12 weeks and monitored for 12 weeks post-treatment.
Efficacy will be measured by wound closure rate (in cm2 of epithelium coverage per week) and wound closure percentage (efficacy measures for the study analyzed through a maximum of 12 weeks of treatment). Safety will be measured by wound-related adverse events, including adverse events of all causes that affect the wound.
"Diabetes and consequential diabetic foot ulcers are a growing healthcare burden impacting millions of people," concluded Preston. “Reaching these two key milestones in the GENESIS trial, full site activation and more than 50% of patients enrolled and randomized, further advances our goal; to become the therapy of choice for the treatment of DFUs, and potentially, severe wounds of all types. We look forward to providing an update and readout of the interim results as early as the third quarter of 2017."