Lakewood-Amedex Selects PERI to Advance Nu-3 Into Phase 2 Trials for Infected Diabetic Foot Ulcers

Antibiotic resistance continues to create major challenges in wound care, especially in patients with diabetic foot infections where delayed or ineffective treatment can lead to hospitalization, amputation, and long-term complications.

Against this backdrop, Lakewood-Amedex Biotherapeutics has announced a new partnership with Professional Education and Research Institute (PERI) to support the upcoming Phase 2 clinical development of Nu-3, the company’s lead antimicrobial candidate for mildly infected diabetic foot ulcers (iDFU).

The collaboration marks an important milestone for Lakewood-Amedex as it advances its novel Bisphosphocin® antimicrobial platform into mid-stage clinical testing.

Nu-3 Targets a Major Unmet Need in Diabetic Foot Infections

Diabetic foot ulcers are among the most serious complications associated with diabetes. When infections develop, they can rapidly become difficult to manage due to:

• Poor wound healing
• Reduced blood circulation
• Biofilm formation
• Rising antimicrobial resistance

Current treatment options often rely heavily on systemic antibiotics, which may become less effective against resistant pathogens such as MRSA and VRE.

Nu-3 is being developed as a locally administered antimicrobial gel designed specifically for infected diabetic foot ulcers. The therapy belongs to Lakewood-Amedex’s proprietary Bisphosphocin® class, a new category of fast-acting broad-spectrum antimicrobials.

According to the company, Nu-3 has demonstrated activity against:

• Antibiotic-resistant bacteria
• Broad bacterial pathogens
• Biofilms commonly associated with chronic wounds

These findings are based on preclinical in vitro and in vivo studies.

Why PERI Was Selected for the Phase 2 Program?

Lakewood-Amedex selected PERI as its contract research organization (CRO) due to the company’s specialized experience in wound care and podiatric clinical research.

PERI was founded by Charles Zelen, a practicing podiatrist with extensive experience treating diabetic foot ulcers.

The organization brings several advantages to the program, including:

• Established investigator networks
• Access to diabetic foot ulcer treatment sites
• Expertise in wound-care study execution
• Operational experience in podiatry-focused clinical trials

The partnership is expected to support patient recruitment efficiency and improve the quality of clinical data collection during the study.

Phase 2 Program Will Evaluate Multiple Nu-3 Gel Concentrations

The upcoming clinical program will evaluate both the safety and efficacy of Nu-3 in patients with mildly infected diabetic foot ulcers.

Phase 2a Study

The initial Phase 2a trial will:

• Use a single-blinded study design
• Compare 2%, 5%, and 10% Nu-3 gel concentrations
• Establish early proof-of-concept data in humans

Phase 2b Study

Following Phase 2a, Lakewood-Amedex plans to initiate a larger Phase 2b trial that will evaluate:

• Different gel concentrations
• Once-daily versus twice-daily dosing
• Comparisons against placebo

The staged approach is designed to optimize dosing while generating additional efficacy and safety data.

Company Leadership Highlights the Importance of the Program

Thomas Balzer described the Phase 2 transition as a major step for the company’s antimicrobial platform.

According to Balzer, advancing Nu-3 into clinical evaluation aligns with the broader goal of addressing the growing threat of antibiotic-resistant infections.

Meanwhile, Dr. Zelen emphasized the urgent clinical need for localized therapies capable of controlling infection while also supporting wound healing in diabetic foot ulcer patients.

The Growing Burden of Infected Diabetic Foot Ulcers

Infected diabetic foot ulcers remain a major global healthcare challenge.

Complications from uncontrolled infections frequently result in:

• Extended hospital stays
• Surgical intervention
• Lower-limb amputations
• Increased mortality risk
• Significant healthcare expenditures

The problem has become even more complex due to increasing rates of antibiotic resistance.

As healthcare systems search for alternatives to traditional systemic antibiotics, locally administered antimicrobial therapies like Nu-3 are attracting growing interest.

About the Bisphosphocin® Platform

Lakewood-Amedex is developing the Bisphosphocin® class as a new category of antimicrobial therapies aimed at combating resistant bacterial infections.

The company states that these compounds are designed to:

• Act rapidly against bacteria
• Deliver broad-spectrum antimicrobial coverage
• Reduce resistance-related treatment limitations
• Address biofilm-associated infections

Beyond diabetic foot ulcers, the platform may eventually support additional infectious disease applications.

Conclusion

The partnership between Lakewood-Amedex and PERI represents an important development in the clinical advancement of Nu-3 for infected diabetic foot ulcers.

With antibiotic resistance continuing to complicate wound care treatment, the success of novel localized antimicrobials could have meaningful implications for both patients and healthcare providers.

The upcoming Phase 2 studies will now determine whether Nu-3’s promising preclinical profile can translate into effective clinical outcomes in one of the most difficult-to-treat infection settings.

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