Lakewood-Amedex Biotherapeutics Goes Public, CEO Discusses Bisphosphocin Technology
In an exclusive interview, Lakewood‑Amedex BiotherapeuticsCEO Kelvin Cooper spoke with The Fly about the company, going public, its Bisphosphocin technology, primary objectives, and more.BISPHOSPHOCIN CLASS:Lakewood-Amedex Biotherapeutics is a clinical-stage biotechnology company advancing a novel class of potent, fast-acting, broad-spectrum antimicrobials for infectious diseases called the Bisphosphocin class."The company's proprietary Bisphosphocin technology is designed to work differently than conventional antibiotics by rapidly disrupting microbial membranes, which may help avoid the emergence of resistance to the class and thereby address the growing challenge of antimicrobial resistance. Our lead candidate, Nu-3, is being developed for mildly infected diabetic foot ulcers, a serious condition with significant medical and economic burden worldwide," CEO Kelvin Cooper explained to The Fly.GOING PUBLIC:Lakewood-Amedex Biotherapeutics went public recently. Cooper views the Nasdaq listing as "an important transition for Lakewood-Amedex from a privately held development-stage company into a broader public market story." "Since listing, we've seen increased engagement from investors, industry participants, and potential strategic partners who recognize both the urgency of the antimicrobial resistance crisis and the need for differentiated technologies in the space," the executive added."Being public also provides us with a stronger platform to communicate our scientific progress, expand corporate visibility, and support the continued advancement of our clinical and preclinical pipeline. Importantly, access to the public markets provides the company with greater financial optionality, including a range of capital formation opportunities as we continue executing on our growth strategy."ANTIMICROBIAL FIELD:Antimicrobial resistance is a rapidly evolving global challenge. Lakewood-Amedex Biotherapeutics' CEO believes the antimicrobial field is approaching an inflection point where healthcare systems increasingly need alternatives to traditional antibiotic approaches.The company is "focused on developing antimicrobial compounds designed to attack pathogens through a broad-spectrum mode of action on microbial membranes, rather than targeting a single metabolic pathway. That distinction is important because it may reduce the ability of microbes to adapt and develop resistance over time. Another key differentiator is our localized delivery strategy, which is intended to concentrate antimicrobial activity directly at the infection site while potentially limiting systemic exposure and therefore limiting the common side effects of systemic antimicrobials – gastrointestinal and immunological," Cooper told The Fly."The activity of the class on biofilms that has been shown in vitro, and which are a major contributor to chronic and difficult-to-treat infections, is another differentiating factor if confirmed clinically. Many existing therapies struggle to effectively penetrate biofilms, particularly in chronic wound environments such as diabetic foot ulcers. Taken together, we believe our platform represents a differentiated approach within a market that is increasingly seeking novel anti-infective mechanisms."WHAT'S NEXT:Looking over the next 12 to 18 months, the company's chief executive sees the primary objective as the "continued clinical advancement of Nu-3 in mildly infected diabetic foot ulcers."Lakewood-Amedex Biotherapeutics recently announced plans for a Phase 2a study intended to evaluate multiple gel concentrations ahead of a larger Phase 2b trial. Those studies are designed to further characterize dosing, safety, and clinical activity as we advance the program."Beyond Nu-3, we intend to continue highlighting the broader applicability of the Bisphosphocin platform across additional infectious disease settings where resistant organisms and biofilms represent significant unmet needs such as complicated urinary tract infections and pulmonary infections," the CEO said.NOT JUST ANOTHER ANTIBIOTIC COMPANY:Discussing any potential misconceptions about the company, Cooper told The Fly that the biggest misconception is that Lakewood-Amedex Biotherapeutics is "just another antibiotic company.""We're not developing incremental antibiotics. We're developing a new class of antimicrobials with a mechanism designed to address resistance at a more fundamental level. Our focus on local delivery, biofilm penetration, and broad-spectrum antimicrobial activity differentiates us from many traditional anti-infective developers," the CEO added.Another misconception is that Lakewood-Amedex Biotherapeutics is "centered around a single product candidate." The company views the Bisphosphocin class as a broader platform technology with potential applications across multiple infectious disease indications. "As awareness around antimicrobial resistance continues to increase globally, we believe investors are beginning to appreciate the broader strategic value of differentiated antimicrobial platforms like ours."Meet the Company" is The Fly's recurring series of exclusive short interviews with Executive Officers to offer a deeper look inside the company.
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- Patent Portfolio Expansion: Lakewood-Amedex Biotherapeutics Inc. now boasts 71 granted patents and 28 pending applications, covering composition, formulation, and use patents, showcasing the company's innovative capabilities in the antimicrobial sector.
- New Patent Issuance: The company has secured new patents in Australia and New Zealand focused on the gel formulation of Bisphosphocin® Nu-3, which is advancing into a Phase 2 clinical trial for mildly infected diabetic foot ulcers, further enhancing its market competitiveness.
- Clinical Trial Progress: Initial clinical trials of Nu-3 have shown a trend of positive antimicrobial response and improved wound healing, with plans for a Phase 2a safety and dose-response study followed by a placebo-controlled Phase 2b comparative study aimed at optimizing the administration regimen.
- Strengthening Strategic Assets: CEO Kelvin Cooper emphasized that expanding the global patent estate is central to protecting innovation, enhancing commercial opportunities, and creating long-term shareholder value, with nearly 100 patents positioning the company strongly in the fight against antimicrobial resistance.
- Clinical Trial Preparation: Lakewood-Amedex Biotherapeutics Inc. announced that its lead product Nu-3 is advancing towards a Phase 2 clinical trial aimed at treating mildly infected diabetic foot ulcers, which is expected to significantly reduce the risk of antimicrobial resistance.
- Production Process Optimization: The company has successfully completed multi-kilogram scale manufacturing of both the active pharmaceutical ingredient and gel formulation under current Good Manufacturing Practices (cGMP), enhancing production efficiency and reducing costs.
- Stability Testing Results: Key stability tests have shown that the Nu-3 bulk drug substance is stable for at least five years, while the drug product has demonstrated undetectable bioburden levels for two years, indicating that it does not require additional preservatives to maintain antimicrobial effectiveness.
- Innovative Antimicrobial Mechanism: The Bisphosphocin® class compounds rapidly kill bacteria through a pH and concentration-dependent mechanism, offering potential to combat antibiotic-resistant strains and may play a significant role in additional indications such as complicated urinary tract infections and pulmonary infections.
- Clinical Trial Partnership: Lakewood-Amedex has entered into an agreement with the Professional Education and Research Institute (PERI) to support the Phase 2 clinical trial of Nu-3, aimed at treating mildly infected diabetic foot ulcers, which is expected to significantly enhance patient treatment outcomes and quality of life.
- Innovative Drug Mechanism: Nu-3 belongs to the novel Bisphosphocin® class of antimicrobials, featuring a unique mechanism that rapidly eliminates a broad spectrum of bacteria, including resistant pathogens, which is anticipated to provide new solutions for antibiotic-resistant infections and meet the growing global healthcare demand.
- Trial Design and Implementation: The planned Phase 2a study will compare gel concentrations of 2%, 5%, and 10% to establish initial proof of concept, followed by a Phase 2b study evaluating different dosing frequencies, aiming to provide more effective treatment options for diabetic foot ulcer patients.
- Market Need and Impact: Infected diabetic foot ulcers represent a significant unmet medical need affecting millions globally, often leading to hospitalization and amputation if not controlled early, and the development of Nu-3 is expected to improve patient outcomes and reduce healthcare costs.
- Significant Antimicrobial Efficacy: Lakewood-Amedex's Nu-3 demonstrated effectiveness against E. coli and MRSA in studies, with no resistance observed over 21 days, indicating its substantial potential in combating antibiotic resistance.
- Urgent Market Need: Approximately 830 million people globally suffer from diabetes, with one-third developing diabetic foot ulcers (DFU), and 50% of DFU cases becoming infected, highlighting Nu-3's critical role in addressing this underserved treatment need.
- Heavy Economic Burden: The estimated cost of care for DFU complications in the U.S. reached $80 billion in 2018, underscoring the necessity for rapid and effective treatments to reduce healthcare costs and hospital stays associated with resistant pathogens.
- Broad-Spectrum Antimicrobial Mechanism: The Bisphosphocin® class compounds exhibit broad-spectrum activity by destabilizing bacterial cell membranes within one minute, potentially providing significant advantages over existing antimicrobial classes in addressing the global antimicrobial resistance crisis.
- Board Enhancement: Lakewood-Amedex Biotherapeutics has appointed Dr. Joseph Tucker to its Board of Directors, a move aimed at strengthening the company's governance capabilities, particularly following its recent direct listing on Nasdaq to enhance strategic decision-making.
- Rich Industry Experience: Dr. Tucker brings over 20 years of leadership experience in biotechnology, having served as CEO in multiple companies and successfully driving various financings and clinical programs, which is expected to provide valuable market insights for the company.
- Product Development Outlook: The company is developing its Nu-3 product for infected diabetic foot ulcers, which has the potential for rapid elimination of a broad spectrum of bacteria, with upcoming clinical trials set to further validate its safety and efficacy.
- Capital Market Strategy: Dr. Tucker's addition is viewed as a crucial step in accelerating the company's growth strategy, especially given his background of raising over $100 million in funding, which is expected to support future financing and market expansion efforts.
- Board Enhancement: Lakewood-Amedex Biotherapeutics has appointed Dr. Joseph Tucker to its Board of Directors, a move aimed at strengthening the company's governance capabilities to support its growth strategy following its recent Nasdaq listing.
- Rich Industry Experience: Dr. Tucker brings over 20 years of leadership experience in biotechnology, having served as CEO in multiple companies, successfully driving strategic financings and clinical programs, which is expected to provide valuable market insights for the company.
- Product Development Outlook: The company's Nu-3 product targets infected diabetic foot ulcers and has the potential to rapidly eliminate a broad spectrum of bacteria, expected to fill a significant gap in the market for antibiotic resistance treatments.
- Clinical Trial Plans: Based on initial clinical trial results, Lakewood-Amedex plans to conduct a Phase 2a safety and dose response study for Nu-3, further validating its efficacy in treating infected diabetic foot ulcers.










