B2i Digital, Inc. has announced that Lakewood-Amedex Biotherapeutics Inc. (NASDAQ: LABT) has become its newest Featured Company, a move that underscores the clinical-stage biotech's progress in developing a novel class of antimicrobials. The Sarasota, Florida-based company is advancing Nu-3, a topical gel formulation of its Bisphosphocin class, toward a Phase 2a trial in infected diabetic foot ulcers (iDFU), a condition with significant unmet medical need due to rising antimicrobial resistance.
The collaboration with B2i Digital comes at a pivotal time for Lakewood-Amedex. The company is finalizing preparations for a proof-of-concept Phase 2a study that will evaluate Nu-3 gel at three concentrations—2%, 5%, and 10%—in patients with infected diabetic foot ulcers. The trial is designed to support progression into a larger Phase 2b study. David G. Armstrong, DPM, M.D., Ph.D., a Distinguished Professor at the Keck School of Medicine of USC, has been named Study Chair and will also serve as a Scientific Advisor, lending his expertise in diabetic foot care.
The significance of Nu-3 lies in its mechanism of action. Bisphosphocin compounds are small nucleotide derivatives that destabilize bacterial cell membranes in a pH- and concentration-dependent manner, typically acting within one minute of exposure. This physical disruption is believed to confer a high barrier to resistance, a critical advantage as conventional antibiotics lose efficacy. In preclinical studies, Nu-3 did not induce resistance in serial passage experiments and demonstrated broad-spectrum activity against bacteria with diverse resistance mechanisms, including MRSA.
The clinical need is substantial. According to the World Health Organization, 830 million people live with diabetes globally. Approximately one-third of these individuals will develop a diabetic foot ulcer, half of which become infected. Among infected cases, 15% to 20% involve resistant pathogens, primarily MRSA. Nu-3's potential to address this resistant population could offer a new treatment avenue where current options are limited.
Preclinical data reported in July indicate that Nu-3 was well tolerated in an FDA-required safety study at doses substantially higher than those planned for the Phase 2a trial, with very low systemic exposure and no inhibition of wound healing. These findings support the proposed dose selection and bolster confidence in the product's safety profile.
Lakewood-Amedex also holds a robust intellectual property estate, with 72 issued patents and 29 pending applications covering composition of matter, formulations, and methods of use. Principal filings extend through 2038, with recent applications through 2044, providing long-term exclusivity for the Bisphosphocin class and Nu-3.
The company began trading on the Nasdaq Capital Market under the symbol LABT after a direct listing in April 2026. This listing, combined with the B2i Digital partnership, aims to raise visibility among retail and institutional investors. David Shapiro, CEO of B2i Digital, noted that the company's unique mechanism and the upcoming trial make it an early-stage investment opportunity worth attention.
Kelvin Cooper, Ph.D., CEO of Lakewood-Amedex, emphasized that the collaboration with B2i Digital will help explain the science and milestones to a broader investor audience, which is often challenging for companies at this stage. As the Phase 2a trial approaches, the outcomes could be pivotal in demonstrating the clinical potential of the Bisphosphocin class in a high-burden disease area.
