B2i Digital, Inc. has announced that Lakewood-Amedex Biotherapeutics Inc. (NASDAQ: LABT) is now a Featured Company on its platform, spotlighting the clinical-stage biotech's work on a novel class of antimicrobials designed to combat antibiotic-resistant bacteria. The Sarasota, Florida-based company is preparing a Phase 2a trial for its lead candidate, Nu-3, a topical gel for infected diabetic foot ulcers, a condition with significant global impact.
The announcement comes as antimicrobial resistance (AMR) continues to erode the effectiveness of existing drugs. David Shapiro, CEO of B2i Digital, emphasized the urgency: "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." He highlighted that Lakewood-Amedex's Bisphosphocin class disrupts bacterial membranes physically, and laboratory studies show Nu-3 has 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," Shapiro added.
The World Health Organization reports 830 million people live with diabetes, and about a third will develop a diabetic foot ulcer. Roughly half of those ulcers become infected, and 15% to 20% of those infections involve resistant pathogens, primarily MRSA. This underscores the potential impact of Nu-3, which targets a significant unmet medical need.
Lakewood-Amedex's Bisphosphocin compounds are small nucleotide derivatives that act by destabilizing the bacterial cell membrane in a pH- and concentration-dependent manner, typically within one minute of exposure. Because the mechanism targets the membrane itself, the company reports that Nu-3 did not induce resistance in serial passage experiments and has shown broad-spectrum in vitro activity against bacteria with diverse resistance mechanisms.
The upcoming Phase 2a proof-of-concept study will evaluate the safety and efficacy of Nu-3 gel at three concentrations (2%, 5%, and 10%) in patients with infected diabetic foot ulcers, with the goal of supporting advancement into a larger Phase 2b trial. Dr. David G. Armstrong, DPM, M.D., Ph.D., Distinguished Professor of Surgery and Neurological Surgery at the Keck School of Medicine of USC, has accepted the role of Study Chair and will also serve as a Scientific Advisor for the program. Dose selection is supported by a preclinical package reported in July, in which 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.
The company also reports a robust intellectual property estate, including 72 issued patents and 29 pending applications, covering composition of matter, formulations, use, and process patents, with principal filings running through 2038 and recent applications through 2044. Lakewood-Amedex began trading on the Nasdaq Capital Market under the symbol LABT following a direct listing in April 2026.
Kelvin Cooper, Ph.D., CEO of Lakewood-Amedex, expressed enthusiasm about the partnership: "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 platform reaches a wide audience of retail and institutional market participants, with a media network spanning 800+ outlets and a combined monthly audience of over 330 million. The company profile for Lakewood-Amedex will be available on B2i Digital's Featured Companies page.
This collaboration is significant as it brings attention to a potential new class of antibiotics that could address the growing threat of drug-resistant infections, a major global health concern. The Phase 2a trial will be a critical step in determining whether Nu-3 can offer a new treatment option for patients with infected diabetic foot ulcers, potentially reducing the burden of AMR.
