OCM™ Wound Platform Demonstrates Antibacterial Activity in Porcine Wound Model, Significantly Reducing Methicillin-Resistant Staphylococcus Aureus (MRSA) and Pseudomonas Aeruginosa (PA) Compared to Comparator and Control Groups

2023-12-08

临床结果

OCM™ was significantly better at halting proliferation of MRSA and PA

OCM™ recorded the lowest bacterial counts of any treatment arm

OCM™ alone and OCM™ plus Omeza® Skin Protectant showed significantly faster formation of new tissue in MRSA-infected wounds than any other treatment

SARASOTA, Fla., Dec. 8, 2023 /PRNewswire/ -- Omeza®, a regenerative skincare company that develops marine-based therapies for the treatment of chronic wounds, today presented in vivo data showing that OCM™ alone significantly reduced methicillin-resistant staphylococcus (MRSA) aureus and pseudomonas aeruginosa (PA) bacterial counts and accelerated the formation of new tissue in MRSA-infected wounds, outperforming a comparator treatment and a control group.

Results of the in vivo data conducted in a porcine model—the most similar to human skin in both morphological structure and immunohistochemical properties1—are being presented at the Innovations in Wound Healing conference Dec. 7 – 10.

"Infections are a leading cause of stalled wounds, with bacteria in biofilms estimated to be involved in more than 60 % of chronic wounds2," said Suzanne Bakewell, Ph.D., Chief Scientific Officer at Omeza®. "Limiting bacterial growth is a critical therapeutic aim in treating advanced wounds, but complicating factors often prevent success. OCM™ does not confer these complications, such as antibiotic resistance, cytotoxicity, or viral transmission."

The current study was designed to evaluate the antimicrobial and wound-healing effects of OCM™ and Omeza® Skin Protectant against a comparator and a control in a porcine wound model. OCM™ is a novel, propriety, drug/device comprising cold-water fish peptides and other pharmaceutical-grade ingredients that create an absorbable matrix which integrates into the wound bed to support the synthesis of new tissue.

Study Design

In the study, wounds were inoculated with MRSA and PA, then treated with either OCM™ alone; OCM™ plus Omeza® Skin Protectant; a silver dressing (positive control); or debridement only (negative control). Wounds in all groups were debrided, treated (except negative control), covered with polyurethane dressings, and retreated on days 4 and 8. All wounds were assessed on Days 4, 8, and 12 for bacterial counts, among other measures.

Study Results

Results of the study showed the following:

OCM™ alone was significantly better at halting proliferation in both MRSA USA300- and PA27312-infected wounds compared with baseline before and after debridement and compared with all other treatment groups.

Among all treatments at all time points, the lowest MRSA USA300 and PA27312 counts occurred on Day 12 in wounds treated with OCM™ alone.

OCM™ alone and OCM™ plus Omeza® Skin Protectant showed significantly faster formation of new tissue in MRSA USA300-infected wounds compared to the silver dressing and the control group.

"These in vivo data constitute an important finding that may have significant clinical implications for the management of many wound etiologies, such as burns, diabetic foot ulcers, venous leg ulcers, and pressure ulcers," said Dr. Windy Cole, DPM, adjunct professor and Director of Wound Care Research at Kent State University College of Podiatric Medicine.

"In recent years, researchers have amassed compelling evidence of multiple pathways through which marine-derived ingredients exert their effects on the immune system and wound healing at both the cellular and molecular levels, including their ability to reduce inflammation and increase metabolic activity of fibroblasts and keratinocytes3-6, which are critical for protecting against microbial invasion," said Dr. Cole.

"The in vivo study of OCM™ supports these foundational studies and demonstrates that a specific therapy—OCM™—confers these antimicrobial benefits in porcine wounds, and the potential is likely in human wounds, as well," Dr. Cole said.

Omeza® is currently evaluating its platform in three clinical studies among patients with diabetic foot ulcers, venous leg ulcers, and chronic wounds of multiple wound etiologies in a real-world setting. Among the endpoints are safety; change in percent area reduction; ability to move wounds from chronicity to a healing trajectory in a 4-week period; and time to complete wound closure.

References:

1https://www-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/pmc/articles/PMC9547536/#:~:text=Porcine%20skin%20is%20often%20used,properties%20(15%E2%80%9318)

2https://www.frontiersin.org/articles/10.3389/fimmu.2021.648554/full

3https://web.archive.org/web/20220425210925id_/https://onlinelibrary-wiley-com.libproxy1.nus.edu.sg/doi/pdf/10.1111/exd.14506

4https://web.archive.org/web/20220425210925id_/https://onlinelibrary-wiley-com.libproxy1.nus.edu.sg/doi/pdf/10.1111/exd.14506

5https://www-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/pmc/articles/PMC6117694/#B98-marinedrugs-16-00256

6https://www.hmpgloballearningnetwork.com/site/wmp/article/nutrition-411-omega-3-fatty-acids-and-wound-healing

About OMEZA®

Omeza® is a commercial-stage regenerative skin and wound-care company that develops marine-based products comprising cold water fish peptides and other pharmaceutical-grade ingredients. Founded in 2014, the company currently markets three products (OCM™, Omeza® Lidocaine Lavage,

and Omeza®Skin Protectant) designed to reduce inflammation, increase skin proliferation, and support skin remodeling in adults with a range of chronic, non-healing wounds. Three clinical trials underway are evaluating the Omeza® platform in diabetic foot ulcers, venous leg ulcers, and wounds of multiple etiologies in the real-world setting. The company is headquartered in Sarasota, Florida, and has research, manufacturing, and analytical facilities located throughout Florida.

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SOURCE Omeza LLC