Origin said today that it treated the 1st patients in its dose-ranging Genesis Phase IIb-equivalent trial. The study is evaluating therapeutic quantities of plasma-generated nitric oxide as a treatment for chronic diabetic foot ulcers.
The 27-week trial is slated to enroll up to 100 patients. Patients will be randomized into 1 of 4 dosing regimens, or receive standard of care as a control, to assess the safety and efficacy of plasma-generated nitric oxide, according to Origin. The company plans to treat the participants for 12 weeks and monitor them for 12 weeks following treatment.
One group of patients will receive a 6 minute dose of nitric oxide twice per week, while another group will receive 6 minutes 4 times a week. Another arm will be treated with 12 minutes of nitric oxide twice per week and the final arm will receive 12 minutes 4 times a week. All patients will be treated with the standard of care, including dressing changes, wound cleansing, pressure relief and wound debridement, Origin reported.
The company said it will measure the effectiveness of its therapy according to wound closure rate and wound closure percentage. Origin also plans to monitor and report any wound-related adverse events.
“Diabetes and consequential diabetic foot ulcers are a growing healthcare burden impacting millions of people,” chairman & CEO Michael Preston said in prepared remarks. “Plasma-generated nitric oxide has the potential to offer a new safe and effective therapy to close wounds actively, serving a large unmet need. This marks another step forward in our mission to become the advanced therapy of choice for the treatment of DFUs. We look forward to providing an update and initial readout of the interim results in the 4th quarter of 2017.”