Lakewood-Amedex Taps Diabetic Foot Expert for Phase 2a Trial of Nu-3
Event summary
- Lakewood-Amedex Biotherapeutics appointed David G. Armstrong, M.D., Ph.D., as Study Chair for its Phase 2a trial of Nu-3 in infected diabetic foot ulcers (iDFUs).
- Dr. Armstrong will also serve as Scientific Advisor for Lakewood-Amedex's iDFU program.
- The Phase 2a trial will evaluate three dose concentrations of topical Nu-3 gel (2%, 5%, and 10%).
- The study aims to support advancement into a larger Phase 2b clinical study.
The big picture
Lakewood-Amedex's appointment of Dr. Armstrong underscores the strategic importance of addressing antibiotic resistance in diabetic foot infections, a growing challenge in wound care management. The Phase 2a trial of Nu-3 could set the stage for a new class of antimicrobials targeting a high-unmet medical need.
What we're watching
- Clinical Efficacy
- Whether Nu-3 demonstrates sufficient safety and efficacy in the Phase 2a trial to justify advancement to Phase 2b.
- Regulatory Pathway
- The pace at which Lakewood-Amedex can navigate regulatory hurdles for its novel antimicrobial therapy.
- Market Differentiation
- How Nu-3's topical approach will position it against existing treatments for infected diabetic foot ulcers.
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