Lakewood-Amedex Biotherapeutics Inc. (LABT), a clinical-stage biotechnology company, announced progress in manufacturing and formulation for its lead investigational drug candidate, Nu-3, being developed to treat infected diabetic foot ulcers.
Nu-3, which is moving towards a Phase 2 trial and is developed as a topically delivered treatment for mildly infected diabetic foot ulcers (iDFU), is intended to reduce the risk of antimicrobial resistance (AMR).
Diabetic foot ulcers are a major complication of diabetes and often lead to infections, amputations, and hospitalisations.
Company Profile
Lakewood-Amedex Biotherapeutics develops Bisphosphocin class antimicrobials to treat infectious diseases and reduce the threat posed by antibiotic-resistant bacterial strains, including MRSA, VRE, and others.
Key Progress Updates
The firm noted that it has conducted drug product gel formulation manufacturing process development and that multikilogram quantities of the Nu-3 gel formulation have been manufactured under cGMP guidelines; the product is suitable for planned clinical trials.
According to the firm, earlier exploratory studies reportedly showed antibacterial activity, improved wound healing and no major safety concerns
Based on these results, the firm plans to conduct an initial Phase 2a safety and dose-response study of Nu-3, followed by a placebo-controlled Phase 2b dose-comparative study. The study will also determine the most appropriate administration regimen for Nu-3 gel formation in mildly infected diabetic foot ulcers.
"Lakewood-Amedex Biotherapeutics has worked diligently to optimise formulation and manufacturing processes required to produce both the Bisphosphocin drug substances and drug products," said Kelvin Cooper, Chief Executive Officer at Lakewood-Amedex Biotherapeutics.
LABT has traded between $1.17 and $9.82 over the last year. The stock closed Friday's trade at $1.50.
Despite the progress update, LABT is currently down 22.67% at $1.15.
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