Lakewood-Amedex Biotherapeutics Inc. saw its shares rise 20% on Friday after the company completed a direct listing on the Nasdaq Capital Market and began trading under the ticker symbol "LABT". The move represents the firm's formal entry into public markets on Nasdaq.
Lakewood-Amedex is a clinical-stage biotechnology company focused on the Bisphosphocin class of antimicrobials intended to treat infectious diseases. The company is advancing Nu-3, a topical candidate designed for use in mildly infected diabetic foot ulcers, as its lead product.
Doug Manion, M.D., the company's Chairman of the Board, characterized the listing as a new chapter for Lakewood-Amedex, saying it will support accelerated development of the Bisphosphocin program and the company's lead compound, Nu-3. The company said that Nu-3 and related Bisphosphocin molecules have a mechanism of action designed to rapidly eliminate a broad spectrum of bacteria, including resistant organisms and biofilms.
Chief Executive Officer Kelvin Cooper, Ph.D., outlined near-term clinical plans, indicating the company intends to initiate a Phase 2a clinical trial of Nu-3 in infected diabetic foot ulcers shortly. He emphasized the potential patient need: close to 40 million people in the U.S. live with diabetes, and roughly one-third of those individuals will develop a diabetic foot ulcer during their life, with about half of such ulcers becoming infected at some point.
Lakewood-Amedex reported that exploratory clinical data using subclinical doses of Nu-3 revealed no safety signals and suggested trends toward an antimicrobial response and improved wound healing. Building on those exploratory results, the company plans an initial Phase 2a study focused on safety and dose response, to be followed by a placebo-controlled Phase 2b dose comparative study.
Market reaction and program status
The 20% share price increase coincided with the Nasdaq listing under LABT. The company remains in the clinical development stage, with the upcoming Phase 2a and Phase 2b studies forming the next critical milestones for Nu-3 and the broader Bisphosphocin class.
What remains to be resolved
While initial exploratory studies at subclinical doses did not reveal safety issues and showed encouraging trends, the company must still complete controlled Phase 2 studies to assess safety, dosing, and comparative efficacy.