Lakewood-Amedex Advances Nu-3 Towards Phase 2 Clinical Trial
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 6 days ago
0mins
Source: PRnewswire
- 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.
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About LABT
Lakewood-amedex Biotherapeutics Inc is a pharmaceutical company. The Company is focused on addressing unmet needs in the treatment of serious infectious diseases, improving patient outcomes, and significantly reducing the threat posed by antibiotic-resistant bacterial strains like MRSA, NDM-1, and many others. The Company is engaged in development of its Bisphosphocin class of antimicrobial agents. The Company is exploring additional local drug delivery applications, including complicated urinary tract infections (CAUTI) and pulmonary infections. The Company has a portfolio of compounds that are being profiled for indications such as infected diabetic foot ulcer, urinary tract infections, and pulmonary infections.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Lakewood-Amedex Advances Nu-3 Towards Phase 2 Clinical Trial
- 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.
See More
Lakewood-Amedex Partners with PERI to Advance Nu-3 Clinical Trial
- 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.
See More
Lakewood-Amedex Announces Positive AMR Data for Nu-3 Antimicrobial
- 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.
See More
Lakewood-Amedex Appoints New Board Member to Strengthen Governance
- 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.
See More
Lakewood-Amedex Appoints New Board Member to Strengthen Governance
- 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.
See More
Lakewood-Amedex Completes Direct Listing on Nasdaq
- 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
See More
Lakewood-Amedex Advances Nu-3 Towards Phase 2 Clinical Trial
- 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.
See More
Lakewood-Amedex Partners with PERI to Advance Nu-3 Clinical Trial
- 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.
See More
Lakewood-Amedex Announces Positive AMR Data for Nu-3 Antimicrobial
- 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.
See More
Lakewood-Amedex Appoints New Board Member to Strengthen Governance
- 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.
See More
Lakewood-Amedex Appoints New Board Member to Strengthen Governance
- 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.
See More
Lakewood-Amedex Completes Direct Listing on Nasdaq
- 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
See More
