Lakewood-Amedex doses first patient in Nu-3 Phase 2a trial for diabetic foot ulcers

Lakewood-Amedex Biotherapeutics has begun dosing patients in a Phase 2a trial of Nu-3 for mildly infected diabetic foot ulcers, marking a key step for its Bisphosphocin antimicrobial platform. Topline data are expected in the first quarter of 2027, with the study designed to guide the next stage of development.

Why it matters: - Diabetic foot infections are hard to treat and can threaten wound healing and limb preservation. - The trial could help determine whether Nu-3, a topical antimicrobial gel, can reduce microbial burden in infected ulcers and support a new treatment approach. - The study is also intended to provide an early clinical test of Lakewood-Amedex Biotherapeutics' Bisphosphocin platform.

What happened: - Lakewood-Amedex Biotherapeutics said the first patient has been dosed in its Phase 2a clinical trial of Nu-3 for mildly infected diabetic foot ulcers. - The company is testing the treatment in adult patients with Type 1 or Type 2 diabetes. - The announcement came on September 24, 2026. - The trial is multicenter, single-blinded and dose-finding.

The details: - The study will evaluate three Nu-3 gel concentrations: 2%, 5% and 10%. - The trial will assess safety and efficacy. - The study will also evaluate Nu-3's ability to reduce microbial burden and resolve infection. - Topline data are expected in the first quarter of 2027. - After the Phase 2a study, the program is expected to move into a Phase 2b trial. - The planned Phase 2b study will test different Nu-3 gel concentrations as once-a-day or twice-a-day treatments against placebo. - Thomas Balzer, Lakewood-Amedex's chief medical officer and senior vice president of clinical development, said the dosing milestone is expected to deliver an important first clinical proof of concept and help validate the Bisphosphocin platform. - David G. Armstrong, a study chair at the Keck School of Medicine of USC, said infected diabetic foot ulcers remain a major challenge and that locally delivered topical antimicrobials could expand treatment options. - Professional Education and Research Institute LLC is managing the Phase 2a trial. - PERI is a contract research organization focused on wound care and podiatric clinical research. - Charles Zelen leads PERI and is a practicing podiatrist with ties to the diabetic foot care community. - PERI's investigator network and access to clinical sites are expected to support patient recruitment and data generation.

Between the lines: - Lakewood-Amedex is positioning Nu-3 as more than a single drug candidate; the company is using the trial to test the broader value of its Bisphosphocin antimicrobial platform. - The focus on local delivery reflects an effort to address infections at the wound site while sidestepping some limitations of conventional systemic treatments. - The trial design suggests the company wants dose and regimen data before advancing to later-stage testing.

What's next: - Lakewood-Amedex will read out Phase 2a topline data in the first quarter of 2027. - The company expects to use those results to select doses and advance Nu-3 into Phase 2b. - Future development will hinge on whether the gel shows enough safety and efficacy to support larger studies and eventual regulatory steps.

The bottom line: - Lakewood-Amedex has crossed a key clinical milestone for Nu-3, but the next data set will determine whether the program can move from early promise to a broader development path. - More information: the company's announcement