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
34th 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.
|
4 WK
PAR
|
12 WK
PAR
|
%
CLOSED
|
OCM™
|
62
|
94
|
57
|
CONTROL
|
42
|
50
|
17
|
"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
View original content to download
multimedia:https://www.prnewswire.com/news-releases/novel-omeza-ocm-wound-healing-platform-combined-with-offloading-in-patients-with-diabetic-foot-ulcers-demonstrated-dramatic-healing-rates-within-12-weeks-or-less-302135616.html
SOURCE Omeza LLC