Lakewood-Amedex Reports Positive AMR Data for Nu-3
Lakewood-Amedex Biotherapeutics announced positive antimicrobial resistance, or AMR, data for its lead compound, Nu-3, which is being developed as a topically delivered treatment for infected diabetic foot ulcers. Nu-3 is one of a new class of antimicrobial compounds discovered by Lakewood-Amedex Biotherapeutics called the Bisphosphocin class, which are also being explored in pre-clinical studies as potential treatments for complicated urinary tract infection and pulmonary infections. The Bisphosphocin class of compounds have been shown to rapidly kill bacteria, typically in under one minute of exposure. This mechanism of action offers the potential to reduce the threat posed by antibiotic-resistant bacterial strains. In laboratory studies, Nu-3 showed slightly increased Minimum Inhibitory Concentration at the end of the experiment for E. coli and were unchanged for MRSA. In contrast, the MIC for the ciprofloxacin control had increased over 2,000-fold for E. coli and over 600-fold for MRSA. In addition, Nu-3 maintained its original MIC when assessed against the bacteria that had developed resistance to Ciprofloxacin, which implies that cross-resistance did not occur.
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- 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.
- Direct Listing Completed: Lakewood-Amedex Biotherapeutics successfully completed its direct listing on Nasdaq on Thursday, with existing shareholders registering to sell up to 4.7 million shares, indicating strong market interest in its antimicrobial treatments despite not raising new capital.
- Equity Sale Details: The company agreed to sell 937,500 shares of Series C Preferred Stock to accredited investors for gross proceeds of $7.5 million, sold at a 20% discount to the stated value of $10 per share, reflecting market valuation of its product potential.
- Product Development Progress: Lakewood-Amedex's lead product candidate, Nu-3, is a synthetic antimicrobial nucleotide derivative for treating chronically infected diabetic foot ulcers, having completed a first-in-human exploratory clinical trial and planning to advance into a Phase 2a safety and dose-response trial.
- Innovative Antimicrobial Class: The company is advancing a novel class of antimicrobials called
- Listing Accelerates R&D: Lakewood-Amedex Biotherapeutics Chairman Doug Manion stated that the listing will expedite the development of the bisphosphocin class of compounds, particularly the lead product Nu-3 aimed at treating infected diabetic foot ulcers.
- Clinical Trial Plans: CEO Kelvin Cooper announced plans to initiate a Phase 2a clinical trial for Nu-3, addressing the significant market need as one-third of the 40 million diabetes patients in the U.S. develop diabetic foot ulcers during their lifetime.
- Stock Surge: Shares of Lakewood-Amedex soared over 8% on their first day of trading on Nasdaq, followed by a remarkable 70% increase in pre-market trading on Friday, bringing the market capitalization to $122 million, indicating strong investor confidence in the company's future.
- Positive Early Trial Results: The company reported that early exploratory trials of Nu-3 at subclinical doses showed no safety concerns and indicated a trend toward antimicrobial activity and improved wound healing, with plans for a subsequent Phase 2b trial to assess different dosing effects.










