B2i Digital, Inc. has announced that Lakewood-Amedex Biotherapeutics Inc. (NASDAQ: LABT) is now a Featured Company on its platform. The Sarasota, Florida-based clinical-stage biotechnology company is developing the Bisphosphocin® class, a novel group of fast-acting, broad-spectrum antimicrobials aimed at addressing infectious diseases and antibiotic-resistant bacterial strains. This partnership will bring Lakewood-Amedex's science and clinical milestones to B2i Digital's extensive network of retail and institutional investors, with a full company profile soon to be available at B2i Digital Featured Companies.
The significance of this announcement lies in the urgent global health threat of antimicrobial resistance (AMR). According to the World Health Organization, AMR is one of the top public health threats, and the pipeline of new antibiotics is limited, with many new drugs being variations of existing mechanisms that bacteria already resist. Lakewood-Amedex's Bisphosphocin® compounds offer a distinct approach: they physically destabilize the bacterial cell membrane in a pH- and concentration-dependent manner, typically within one minute of exposure. This novel mechanism has shown a high barrier to resistance in laboratory studies, as Nu-3 did not induce resistance in serial passage experiments and demonstrated broad-spectrum activity against bacteria with diverse resistance mechanisms, including MRSA.
The lead candidate, Nu-3, is a topical gel being developed for infected diabetic foot ulcers (iDFU), a complication affecting a substantial patient population. With 830 million people living with diabetes globally, about one-third will develop a diabetic foot ulcer, half of which become infected, and 15-20% of those infections involve resistant pathogens like MRSA. This highlights the potential clinical and commercial impact of Nu-3 if it proves effective.
Lakewood-Amedex is preparing a Phase 2a proof-of-concept study to 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 designed to support advancement into a larger Phase 2b trial. Notably, David G. Armstrong, DPM, M.D., Ph.D., a distinguished professor at the Keck School of Medicine of USC, has been appointed as Study Chair and Scientific Advisor for the iDFU program, lending significant clinical credibility to the trial.
The company's preclinical package, reported in July, showed that Nu-3 was well tolerated in an FDA-required safety study at doses substantially higher than planned for Phase 2a, with very low systemic exposure and no inhibition of wound healing. This data supports the progression to human trials.
Lakewood-Amedex holds a robust intellectual property estate with 72 issued patents and 29 pending applications, covering composition of matter, formulations, and methods of use for the Bisphosphocin® class, with principal filings extending through 2038 and recent applications through 2044. The company began trading on the Nasdaq Capital Market under the symbol LABT following a direct listing in April 2026.
David Shapiro, CEO of B2i Digital, commented, "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."
Kelvin Cooper, Ph.D., CEO of Lakewood-Amedex, added, "Our focus is on bringing the Bisphosphocin® class into the clinic and generating the proof-of-concept data that will define its potential in infected diabetic foot ulcers. Working with B2i Digital gives us the opportunity to explain that science, and the milestones ahead of it, to a much broader group of investors than a company at our stage would normally reach."
The collaboration with B2i Digital is expected to enhance visibility for Lakewood-Amedex as it approaches this critical clinical milestone, potentially attracting investment to support the advancement of a novel antimicrobial class in the fight against resistant infections.
