Lakewood-Amedex wins IRB approval for Nu-3 Phase 2a diabetic foot ulcer trial

Lakewood-Amedex Biotherapeutics said Sept. 18 it received central and site IRB approvals to begin a Phase 2a trial of Nu-3 in mildly infected diabetic foot ulcers. The study is a key step for the company’s antibiotic-resistant infection program and could help advance a treatment for wounds that often lead to amputation.

Why it matters: - Diabetic foot ulcers are a major medical problem and can lead to lower-limb amputations. - Lakewood-Amedex is trying to move Nu-3, its lead product candidate, into human testing for an infection type with limited treatment options. - The company’s goal is to develop resistance-evading antimicrobials for drug-resistant wound infections.

What happened: - Lakewood-Amedex Biotherapeutics said it received central and all-site Institutional Review Board approvals for a Phase 2a clinical trial of Nu-3. - The trial is set to evaluate Nu-3 in patients with mildly infected diabetic foot ulcers. - The company said clinical trial sites are ready to begin. - The announcement was made Sept. 18, 2026.

The details: - Nu-3 is a proprietary topical gel formulation. - Nu-3 works by destabilizing microbial cell membranes. - Lakewood-Amedex says that mechanism creates a high barrier to antimicrobial resistance. - The Phase 2a study builds on positive preclinical safety data and early exploratory results. - Those earlier results showed Nu-3 was well-tolerated and trended toward improved antimicrobial response and wound healing. - Thomas Balzer, Lakewood-Amedex’s chief medical officer, said the company is positioned to evaluate whether Nu-3 can improve outcomes in iDFU. - Balzer said the study is being guided by study chair Dr. David G. Armstrong.

Between the lines: - The IRB approvals remove an important clinical hurdle, but they do not guarantee the trial will succeed. - The company is aligning its development plan with federal PACCARB priorities focused on antibiotic resistance. - Lakewood-Amedex is framing Nu-3 as part of a broader shift toward treatments that can avoid traditional resistance pathways. - The company’s focus on wound infections targets a space where faster-acting antimicrobials could have clear clinical value.

What’s next: - Lakewood-Amedex is expected to start the Phase 2a trial now that approvals and site readiness are in place. - The company will use the study to assess Nu-3’s safety and efficacy in mildly infected diabetic foot ulcers. - Future results could support next steps in the product’s clinical development program. - The company also faces the usual risks tied to trial timing, trial success, manufacturing, financing, and regulatory review.

The bottom line: - Nu-3 has cleared a key step toward mid-stage testing, giving Lakewood-Amedex a closer look at whether its topical antimicrobial can help treat a difficult and high-stakes wound infection.