LONDON, May 3, 2024 /PRNewswire/ -- Omeza®, a regenerative skincare company that develops marine-based therapies for wounds that are hard to treat, today presented final data from a diabetic foot ulcer (DFU) clinical trial showing that Omeza® OCM^™ plus offloading of weight on the affected foot achieved a 94 percent area reduction (PAR) rate in DFUs within twelve weeks, and a 62 percent PAR within four weeks. PAR is considered a surrogate endpoint of complete wound healing, with a PAR of 50 percent at four weeks in diabetic wound patients considered a strong predictor of subsequent complete healing.¹

Final data from the clinical trial are being presented at the 34^th annual Conference of the European Wound Management Association (EWMA) May 1-3.

"Diabetic foot ulcers are one of the leading causes of mortality, morbidity, and lower extremity amputations in patients with diabetes, and the medical community continuously strives to identify novel therapies to prevent or reduce these complications and their significant burden to patients, families, and the healthcare system at large," said Dr. Richard Simman, Professor of Plastic Surgery at the University of Toledo College of Medicine, Jobst Vascular Institute at ProMedica Health System in Toledo, Ohio. ProMedica conducted the DFU clinical trial.

"We're extremely encouraged by the final results of our clinical trial evaluating Omeza®'s OCM^™ platform, which showed significant healing—and in over half the cases, complete closure—of patients' diabetic wounds in twelve weeks or less. This is a notable achievement, given the resistance to standard treatments that DFUs often display," said Simman, principal investigator at the ProMedica clinical trial site.

In the study, 19 patients with DFUs were treated with OCM^™, a drug/device containing cold water fish peptides and other pharmaceutical-grade components that create an absorbable matrix which conforms to the wound bed and supports the synthesis of new tissue. Patients also reduced or eliminated weight bearing on the affected foot, known as offloading, to support healing. A control group received current standards of wound care, including offloading, debridement, collagen, hypochlorite solution, and/or wound dressings containing silver alginate.

Final Study Results

At the conclusion of the study, all subjects in the treatment group saw a PAR greater than 73%, with 3 subjects seeing a PAR of 100% at 4 weeks of treatment. Eight of fourteen subjects achieved 100% PAR at 12 weeks. Five patients had DFUs that were greater than 12 months old, and 3 of those patients had 100% PAR. No adverse events related to the treatment were reported during the study.

"It is gratifying to see the positive impact of OCM^™ on patients who had been struggling without resolution from ulcers that are very difficult to treat, and to demonstrate these positive results in both a real-world setting as well as in a clinical trial truly reinforces the potential of Omeza® OCM^™ to fulfill an unmet need for patients with nonhealing wounds, said Desmond Bell, DPM, Chief Medical Officer at Omeza®.

"All of the components in OCM^™ are natural, pharmaceutical-grade ingredients that are known to be safe and have been shown to harness an individual's innate immune processes to activate healing at the site of the wound," Bell said. "Our ongoing in vivo and in vitro studies will further elucidate the mechanisms of action that underlie the exciting results we're accumulating in clinical trials and the real-world setting."

Studies to further evaluate the performance of OCM^™ in patients with venous leg ulcers (VLUs) and in other wound types are underway, and ProMedica will begin recruiting patients for a VLU RCT trial starting Q4 2024.

References:

¹ https://www.jvascsurg.org/article/S0741-5214(22)02154-1/fulltext

About OMEZA

Omeza® is a commercial-stage regenerative skin and wound-care company that develops marine-based products comprising containing cold water fish peptides and other pharmaceutical-grade components designed to reduce inflammation, increase tissue proliferation, and support skin remodeling in adults with a range of chronic, non-healing wounds. Founded in 2014, the company currently markets OCM^™ for the treatment of nonhealing wounds. OCM^™ is also being evaluated in real-world settings and in multiple clinical trials to compare the effects of OCM^™ versus standard of care on wound healing, pain reduction, quality of life, and other secondary endpoints in patients with diabetic ulcers, chronic venous leg ulcers, and multiple other wound types. The company is headquartered in Sarasota, Florida, and has research, manufacturing, and analytical facilities located throughout Florida.

Media Contacts:
Bernadette Cupit
bcupit@omeza.com
908-334-4554

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SOURCE Omeza LLC