Lakewood-Amedex Doses First Patient in Phase 2a Trial for Diabetic Foot Ulcer Treatment — Lakewood-Amedex Biotherapeutics Inc.

Event summary

First patient dosed in Phase 2a trial of Nu-3 for mildly infected diabetic foot ulcers.
Study evaluates three gel concentrations (2%, 5%, 10%) to assess safety and efficacy.
Topline data expected in Q1 2027, with Phase 2b study planned thereafter.
Trial managed by PERI, a contract research organization with expertise in wound care.

The big picture

Lakewood-Amedex's Phase 2a trial for Nu-3 addresses a critical unmet need in diabetic foot ulcer treatment, particularly as antimicrobial resistance complicates infection management. The study's success could validate the company's Bisphosphocin® platform, potentially expanding treatment options for millions of patients worldwide. The trial's design, including dose-finding and comparative efficacy assessments, reflects a strategic focus on optimizing Nu-3's clinical and commercial potential.

What we're watching

Clinical Efficacy: Whether Nu-3 can demonstrate superior microbial reduction and infection resolution compared to existing treatments.
Regulatory Pathway: The pace at which Lakewood-Amedex can advance Nu-3 through subsequent clinical phases and secure regulatory approval.
Market Differentiation: How Nu-3's topical delivery mechanism and broad-spectrum antimicrobial properties position it against competitors in the diabetic foot ulcer market.