B2i Digital, Inc. has announced Lakewood-Amedex Biotherapeutics Inc. (NASDAQ: LABT) as its newest Featured Company, aiming to bring attention to the clinical-stage biotechnology firm's development of a novel class of antimicrobials. The Sarasota, Florida-based company is preparing a Phase 2a trial of Nu-3, a topical gel formulation, for infected diabetic foot ulcers (iDFU). This partnership is significant because it underscores the potential of a new mechanism of action to combat antimicrobial resistance (AMR), a growing global health threat.
The Bisphosphocin class, developed by Lakewood-Amedex, represents a departure from traditional antibiotics. Instead of targeting specific bacterial proteins or pathways, these compounds act by physically disrupting the bacterial cell membrane in a pH- and concentration-dependent manner, typically within one minute of exposure. This novel mechanism is critical because it may circumvent the resistance mechanisms that bacteria have evolved against existing drugs. According to the company, Nu-3 did not induce resistance in serial passage experiments and has shown broad-spectrum in vitro activity against resistant strains, including MRSA.
The Phase 2a trial is designed to evaluate the safety and efficacy of Nu-3 gel at three concentrations (2%, 5%, and 10%) in patients with infected diabetic foot ulcers. The study will be chaired by David G. Armstrong, DPM, M.D., Ph.D., a Distinguished Professor at the Keck School of Medicine of USC, who also serves as a Scientific Advisor for the program. The trial's results are intended to support advancement into a larger Phase 2b study. Preclinical data reported in July indicated that Nu-3 was well tolerated in FDA-required safety studies at doses substantially higher than those planned for the trial, with very low systemic exposure and no inhibition of wound healing.
The urgency of this work is underscored by the scale of the problem: 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 15-20% of infections involve resistant pathogens, primarily MRSA. With the rise of AMR, the need for new classes of antibiotics is critical. The Bisphosphocin class could offer a solution that bacteria are less likely to develop resistance against due to its physical mechanism of action.
Lakewood-Amedex holds a robust intellectual property estate, with 72 issued patents and 29 pending applications covering composition of matter, formulations, and processes, with principal filings running through 2038 and recent applications extending to 2044. The company began trading on the Nasdaq Capital Market under the symbol LABT in April 2026 after a direct listing.
David Shapiro, CEO of B2i Digital, highlighted the importance of the partnership: “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.”
B2i Digital's campaign will center on Nu-3, the upcoming Phase 2a trial, and the Bisphosphocin class. A full company profile is expected to be available soon on B2i Digital's Featured Companies page. The partnership aims to connect Lakewood-Amedex with a wide network of retail and institutional investors through B2i Digital's media and conference platforms.
