Lakewood-Amedex Biotherapeutics Inc. announced that its common stock has begun trading on the Nasdaq Capital Market under the symbol "LABT" following a direct listing. The move marks the company’s entry into the public markets as it advances clinical development of its antimicrobial portfolio.
Headquartered in Sarasota, Florida, the clinical-stage biotechnology company is developing a novel class of antimicrobials it calls the Bisphosphocin class. The company’s lead candidate, Nu-3, is being developed specifically for topical treatment of infected diabetic foot ulcers.
"This listing is a notable achievement marking a new chapter for our company enabling the accelerated development of our Bisphosphocin class of compounds," said Doug Manion, M.D., Chairman of the Board.
Management has outlined a clinical development pathway for Nu-3 that begins with an initial Phase 2a study focused on safety and dose response in infected diabetic foot ulcers. The company intends to follow that with a placebo-controlled Phase 2b dose comparative trial to determine the appropriate administration regimen for the treatment.
Chief Executive Officer Kelvin Cooper, Ph.D., highlighted the potential patient population in the United States, noting that roughly 40 million people live with diabetes and that about one-third of those individuals will develop diabetic foot ulcers during their lifetime. The company additionally noted that approximately half of those ulcers become infected.
According to the company, Nu-3 is part of the Bisphosphocin class of antimicrobials, which it describes as having a mechanism of action designed to eliminate bacteria, including resistant pathogens and biofilms. The press release states that initial exploratory clinical trials using subclinical doses produced no safety signals and showed trends toward positive antimicrobial responses and improved wound healing.
With the Nasdaq listing now complete, Lakewood-Amedex has set a clear near-term development schedule - advancing Nu-3 through a Phase 2a safety and dose-response study and then into a placebo-controlled Phase 2b dose comparative trial aimed at selecting the appropriate administration regimen.
Summary
Lakewood-Amedex has begun Nasdaq trading as LABT via a direct listing. The Sarasota-based, clinical-stage biotechnology company is developing Bisphosphocin-class antimicrobials, with Nu-3 aimed at treating infected diabetic foot ulcers. The company will initiate a Phase 2a study followed by a placebo-controlled Phase 2b to refine dosing and administration.
Key points
- Lakewood-Amedex's common stock now trades on the Nasdaq Capital Market under the ticker LABT after a direct listing.
- The company is developing Bisphosphocin-class antimicrobials; lead candidate Nu-3 targets infected diabetic foot ulcers and will enter Phase 2a, then a placebo-controlled Phase 2b.
- Sectors affected include biotechnology and healthcare, particularly companies focused on anti-infectives and wound care, and market participants tracking small-cap biotech listings.
Risks and uncertainties
- Clinical outcome uncertainty - Nu-3 must demonstrate safety and efficacy in Phase 2a and Phase 2b trials; earlier exploratory trials were limited to subclinical doses and only showed trends.
- Dosing and administration remain to be determined - the company plans sequential studies specifically to establish the appropriate administration regimen, indicating current uncertainty on optimal dosing.