B2i Digital, Inc. has announced that Lakewood-Amedex Biotherapeutics Inc. (NASDAQ: LABT) is now a Featured Company on its platform. This designation brings attention to the clinical-stage biotechnology company's work on the Bisphosphocin® class, a novel group of antimicrobials designed to combat antibiotic-resistant bacteria. The B2i Digital campaign will focus on Nu-3, the company's lead candidate, and the upcoming Phase 2a trial for infected diabetic foot ulcers (iDFU), a condition with significant unmet medical need.
The urgency of this development is underscored by the growing threat of antimicrobial resistance (AMR). As David Shapiro, CEO of B2i Digital, noted, "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." In contrast, Lakewood-Amedex's Bisphosphocin® compounds are proposed to act by physically destabilizing the bacterial cell membrane, a mechanism that may present a high barrier to resistance. Shapiro added, "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 significance of this trial lies in 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. Roughly half of these ulcers become infected, and 15-20% of infections involve resistant pathogens, primarily MRSA. Nu-3, a topically delivered gel, is being developed to address this critical need. The Phase 2a proof-of-concept study will evaluate the safety and efficacy of Nu-3 at three concentrations (2%, 5%, and 10%) in patients with infected diabetic foot ulcers, with results intended to support advancement into a larger Phase 2b study.
The trial is chaired by David G. Armstrong, DPM, M.D., Ph.D., a Distinguished Professor of Surgery and Neurological Surgery at the Keck School of Medicine of USC, who will also serve as a Scientific Advisor. Dose selection is based on a preclinical package reported in July, in which Nu-3 was well tolerated at levels substantially higher than planned for Phase 2a, with very low systemic exposure and no inhibition of wound healing.
Lakewood-Amedex's intellectual property estate includes 72 issued patents and 29 pending applications, covering composition of matter, formulations, and use patents, with principal filings running 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.
Kelvin Cooper, Ph.D., CEO of Lakewood-Amedex, emphasized the importance of this 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."
As the world grapples with the rise of antibiotic-resistant infections, the development of novel antimicrobial classes like Bisphosphocins is of paramount importance. The upcoming Phase 2a trial represents a critical step in determining whether Nu-3 can offer a new treatment option for patients with infected diabetic foot ulcers, a condition that often leads to severe complications, including amputation. For more information about Lakewood-Amedex and its programs, visit https://lakewoodamedex.com. To learn more about B2i Digital and its Featured Companies, visit https://b2idigital.com.
