B2i Digital, Inc. has announced that Lakewood-Amedex Biotherapeutics Inc. (NASDAQ: LABT) is now a Featured Company on its platform, bringing attention to the clinical-stage biotechnology firm's pioneering work in antimicrobials. Lakewood-Amedex, based in Sarasota, Florida, is developing the Bisphosphocin® class, a novel group of fast-acting, broad-spectrum antimicrobials designed to combat infectious diseases and antibiotic-resistant bacterial strains. The partnership with B2i Digital aims to introduce this innovative science and its upcoming clinical milestones to a wide network of retail and institutional investors.
The core of the campaign centers on Nu-3, the company's lead candidate, a topical gel formulation targeting infected diabetic foot ulcers (iDFU). This condition is a significant global health concern: the World Health Organization reports 830 million people living with diabetes, about a third of whom will develop a diabetic foot ulcer. Approximately half of those ulcers become infected, and 15% to 20% of infected cases involve resistant pathogens, primarily MRSA. These statistics underscore the urgent need for new treatment options, especially as antimicrobial resistance continues to erode the efficacy of existing drugs.
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 this 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 carrying diverse resistance mechanisms. This high barrier to resistance is a critical advantage in an era where traditional antibiotics are becoming less effective.
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 three concentrations (2%, 5%, and 10%) in patients with infected diabetic foot ulcers. The trial is designed to support advancement into a larger Phase 2b study. Notably, David G. Armstrong, DPM, M.D., Ph.D., Distinguished Professor of Surgery and Neurological Surgery at the Keck School of Medicine of USC, has been appointed 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, which showed that 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's intellectual property estate includes 72 issued patents and 29 pending applications, covering composition of matter for the Bisphosphocin® class, formulations of Nu-3, and use 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.
David Shapiro, CEO of B2i Digital, commented on 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."
For more information about B2i Digital's Featured Companies, visit https://b2idigital.com/featured-companies. Details about Lakewood-Amedex can be found at https://lakewoodamedex.com.
