Lakewood-Amedex reports positive data for lead diabetic-foot-ulcer candidate

Lakewood-Amedex Biotherapeutics said its lead candidate Nu-3 has cleared development milestones that support a planned Phase 2 trial in mildly infected diabetic foot ulcers.

The company said in a release published Monday, May 18, that it completed cGMP formulation and drug-substance work for the topical treatment and produced multikilogram gel quantities suitable for clinical trials. It also said stability testing indicated the bulk drug substance is stable for at least five years and the gel formulation for at least two years.

Lakewood-Amedex said the findings support advancement of Nu-3 toward Phase 2 in infected diabetic foot ulcers. The company describes Nu-3 as a topical candidate for mildly infected ulcers.

The update follows an earlier company disclosure in May about Nu-3 and antimicrobial-resistance-related data. No trial start date was announced in the latest release.