NEW YORK, NY — B2i Digital, Inc. has announced Lakewood-Amedex Biotherapeutics Inc. (NASDAQ: LABT) as its newest Featured Company, a move that will bring the clinical-stage biotechnology firm's work on a novel class of antimicrobials to a broader investment audience. The Sarasota, Florida-based company is developing the Bisphosphocin® class, a group of fast-acting, broad-spectrum antimicrobials designed to combat infectious diseases and antibiotic-resistant bacterial strains.
David Shapiro, Chief Executive Officer of B2i Digital, highlighted the significance of Lakewood-Amedex's approach. "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 said. "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."
The collaboration with B2i Digital provides Lakewood-Amedex with a platform to explain its science and upcoming milestones to a wider network of retail and institutional market participants. Kelvin Cooper, Ph.D., Chief Executive Officer of Lakewood-Amedex, stated, "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."
Bisphosphocin® compounds are small nucleotide derivatives that destabilize the bacterial cell membrane in a pH- and concentration-dependent manner, typically acting within one minute of exposure. This physical mechanism is key to the drug's potential; the company reports that Nu-3 did not induce resistance in a serial passage experiment and has shown broad-spectrum in vitro activity against bacteria carrying diverse resistance mechanisms. Nu-3, the lead candidate, is a topical gel formulation targeting infected diabetic foot ulcers (iDFUs), a condition of significant global impact. The World Health Organization estimates that 830 million people live with diabetes, about a third of whom will develop a diabetic foot ulcer, with roughly half of those becoming infected. Furthermore, 15% to 20% of infected cases involve resistant pathogens, primarily MRSA.
Lakewood-Amedex is finalizing preparations for a Phase 2a proof-of-concept study to evaluate the safety and efficacy of topical Nu-3 gel at 2%, 5%, and 10% concentrations in patients with infected diabetic foot ulcers. The study is intended to support advancement into a larger Phase 2b trial. In June, David G. Armstrong, DPM, M.D., Ph.D., Distinguished Professor of Surgery and Neurological Surgery at the Keck School of Medicine of USC, accepted the position of Study Chair and will also serve as a Scientific Advisor on the iDFU program. Dose selection is based on 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 holds an intellectual property estate of 72 issued patents and 29 pending applications, covering composition of matter for the Bisphosphocin® class, formulations of Nu-3, use patents, and process patents. Principal filings run through 2038, with recent applications extending to 2044. Lakewood-Amedex began trading on the Nasdaq Capital Market under the symbol LABT following a direct listing in April 2026.
B2i Digital's Featured Company profile for Lakewood-Amedex is forthcoming at https://b2idigital.com/featured-companies. The partnership underscores the growing interest in novel antimicrobial approaches as antibiotic resistance becomes an increasingly urgent global health threat.
