As antibiotic resistance continues to erode the efficacy of existing treatments, the need for novel mechanisms of action has never been more urgent. In response, B2i Digital, Inc. has announced that Lakewood-Amedex Biotherapeutics Inc. (NASDAQ: LABT), a clinical-stage biotech based in Sarasota, Florida, is now a Featured Company on its platform. The partnership aims to raise awareness about Lakewood-Amedex's Bisphosphocin class—a new family of broad-spectrum antimicrobials designed to combat resistant bacterial strains—and the company's upcoming Phase 2a clinical trial for its lead candidate, Nu-3, a topical gel for infected diabetic foot ulcers.
David Shapiro, CEO of B2i Digital, emphasized the significance of the collaboration: "Antimicrobial resistance keeps narrowing the list of drugs that still work against all pathogens, and the compounds coming to replace them are mostly variations on mechanisms that bacteria have already learned to defeat. Lakewood-Amedex has spent years on a compound class that disrupts the bacterial membrane physically, and in laboratory work Nu-3 has demonstrated a high barrier to resistance. The company is preparing a Phase 2a trial in infected diabetic foot ulcers with one of the field’s most respected clinicians as study chair, which makes this a company investors should meet early."
The Bisphosphocin compounds work by destabilizing the bacterial cell membrane in a pH- and concentration-dependent manner, typically within one minute of exposure. This physical mode of action is distinct from traditional antibiotics, which often target specific metabolic pathways that bacteria can mutate. Consequently, the company reports that Nu-3 did not induce resistance in serial passage experiments and has shown broad-spectrum in vitro activity against bacteria carrying diverse resistance mechanisms.
The clinical focus on infected diabetic foot ulcers is particularly relevant, given the global diabetes burden. The World Health Organization estimates that 830 million people live with diabetes, and about one-third will develop a diabetic foot ulcer. Of those, roughly half become infected, and 15% to 20% of infections involve resistant pathogens, primarily MRSA. This represents a substantial unmet medical need, as current treatment options are often limited and invasive, sometimes leading to amputation.
Lakewood-Amedex is finalizing preparations for a Phase 2a proof-of-concept study that will evaluate the safety and efficacy of topical Nu-3 gel at three concentrations (2%, 5%, and 10%) in patients with infected diabetic foot ulcers. The study is intended to support advancement into a larger Phase 2b trial. Notably, David G. Armstrong, DPM, M.D., Ph.D., a Distinguished Professor of Surgery and Neurological Surgery at the Keck School of Medicine of USC, has been appointed as Study Chair, bringing significant expertise to the program.
Preclinical data reported in July showed that Nu-3 was well tolerated in an FDA-required safety study at dose levels substantially higher than those planned for Phase 2a, with very low systemic exposure and no inhibition of wound healing. These findings support the planned dose selection and bolster confidence in the compound's safety profile.
The company also holds a robust intellectual property estate, with 72 issued patents and 29 pending applications covering composition of matter, formulations, uses, and processes, with principal filings running through 2038 and recent applications through 2044. This extensive IP protection is crucial for a biotech at this stage, as it secures the commercial potential of the Bisphosphocin class.
Lakewood-Amedex began trading on the Nasdaq Capital Market under the symbol LABT following a direct listing in April 2026. The B2i Digital Featured Company program will provide the company with visibility among a wide network of retail and institutional investors, leveraging B2i Digital's media reach of over 800 outlets and a combined monthly audience of more than 330 million.
As the threat of antimicrobial resistance grows, the development of novel therapeutic approaches like the Bisphosphocin class is of paramount importance. The upcoming Phase 2a trial represents a critical milestone for Lakewood-Amedex, and the partnership with B2i Digital is poised to bring this innovative science to the forefront of investor attention.
