A Prospective, Randomized, Single-Blind Phase 2a Multi-Center Dose Comparative Study to Evaluated The Safety, Tolerability, and Antimicrobial Efficacy Of Topically Twice Daily Applied Bisphosphocin Nu-3 Gel At a 2%, 5%, And 10% Concentration To Infected Diabetic Foot Ulcers (iDFU)

The goal of this clinical trial is to learn if drug Nu-3 works to treat mildly infected diabetic foot ulcers in adults with Type 1 or Type 2 diabetes at 3 different dose levels. It will also learn about the safety of drug Nu-3. The main questions it aims to answer are:
Does drug Nu-3 lower the number of bacteria or viruses in the infected ulcer, or cure patients of the infection, at any or all of the dose levels being tested after 1 week or 2 weeks? What medical problems do participants have when taking the topical drug Nu-3? Researchers will compare drug Nu-3 at different dose levels to see if drug Nu-3 works to treat the infected ulcers at each of the dose levels.
Participants will:
Take drug ABC or a placebo every day for 4 months Visit the clinic once every 2 weeks for checkups and tests Keep a diary of their symptoms and the number of times they use a rescue inhaler

开始日期2026-08-01

申办/合作机构

Lakewood-Amedex, Inc.

NCT06020235

/ Not yet recruiting临床2期

A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate Safety and Antimicrobial Efficacy of Topically Once or Twice Daily Applied Bisphosphocin® Nu-3 Gel At 5% and 10% Concentrations to Infected Diabetic Foot Ulcers (iDFU)

The goal of this clinical trial is to test a topical drug in patients with mild infections of their diabetic foot ulcer. The main questions it aims to answer are:
What strength does the drug need to be in order to make the infection better? How frequently does the drug need to be applied in order to make the infection better? Participants will be asked to apply the medicine on their foot ulcer twice a day for 2 weeks and remain off of that foot during that time.
Participants will receive the medication either once a day or twice a day, in either a 5% or 10% gel, or placebo.
Researchers will compare the 5% and 10% gels to placebo to see if the infection improves.

开始日期2025-12-01

申办/合作机构

Lakewood-Amedex, Inc.

NCT05276401

/ Terminated临床2期

A Phase 2a, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Dose Escalating Study to Evaluate the Safety and Tolerability of Topically Applied Bisphosphocin Nu-3 Gel to Clinically Noninfected Chronic Diabetic Foot Ulcers (cDFU)

A PHASE 2a, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE ESCALATING STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF TOPICALLY APPLIED BISPHOSPHOCIN NU-3 GEL TO CLINICALLY NONINFECTED CHRONIC DIABETIC FOOT ULCERS (cDFU)

开始日期2022-03-11

申办/合作机构

Lakewood-Amedex, Inc.

[+2]

100 项与 Bisphosphocin Nu3 相关的临床结果

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100 项与 Bisphosphocin Nu3 相关的转化医学

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100 项与 Bisphosphocin Nu3 相关的专利（医药）

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项与 Bisphosphocin Nu3 相关的文献（医药）

2025-12-10·ANTIMICROBIAL AGENTS AND CHEMOTHERAPY

Article

作者: DiTullio, Paul ; Murthy, Kanneganti ; Balzer, Thomas ; Cooper, Kelvin ; Sleet, Randy ; Parkinson, Steve

ABSTRACT:

Lakewood-Amedex Biotherapeutics Inc. has developed a new class of antimicrobials called the Bisphosphocin class, with Nu-3 as a leading candidate, which is currently in clinical development for treating mildly infected diabetic foot ulcers (iDFUs). Nu-3 acts through a novel mechanism of action that destabilizes bacterial membranes within minutes, which significantly reduces the potential for resistance development. It demonstrates broad-spectrum activity against Gram-positive, Gram-negative, and multidrug-resistant bacteria, including recent clinical isolates from infected wounds. Nu-3 is especially effective in acidic environments and can be formulated for topical application at high concentrations and low pH, that has been shown to be beneficial for wound healing, making it well-suited for treating infections in diabetic foot ulcers. Its rapid, bactericidal action has been confirmed against pathogens, such as Staphylococcus aureus , Escherichia coli , Pseudomonas aeruginosa, Klebsiella pneumoniae, Propionibacterium acnes, Proteus mirabilis, Acinetobacter baumannii, and Staphylococcus saprophyticus , with complete bacterial eradication occurring within minutes. Resistance testing over 21 days showed a very low probability of resistance development. In vivo testing in murine dermal methicillin-resistant Staphylococcus aureus (MRSA) infection models demonstrated robust efficacy for Nu-3 given as a solution- or gel-formulation in both single and multidose protocols. Given its efficacy, broad-spectrum activity, and topical formulation, Nu-3 has the potential to be an important therapeutic intervention for the treatment of mild infections in diabetic foot ulcers—a serious complication of diabetes associated with high amputation risk.

2010-01-01·Journal of biomedicine & biotechnology

Acute, Multiple-Dose Dermal and Genetic Toxicity of Nu-3: A Novel Antimicrobial Agent

Article

作者: Wang, Ming ; Cao, Shanping ; Sun, Lun-Quan ; Zhang, Guozhong ; Sun, Juan ; Hu, Yanxin

Nu-3 [butyl-phosphate--thymidine--phosphate-butyl] is a modified nucleotide that has been shown to have antimicrobial activity against a range of bacteria includingPseudomonas aeruginosa. However, data on the toxicological profile of Nu-3 are still lacking. In the present study, the toxicity of Nu-3 was evaluated by the following studies: acute oral toxicity, dermal and mucous membrane irritation, multiple-dose toxicity and genotoxicity in vivo and vitro. The acute oral toxicity test in mice showed that Nu-3 had an of 2001mg/kg body weight. The irritation tests on rats revealed that Nu-3 was not irritant, with an irritation scoring of 0. The multiple-dose toxicity study in rats showed that Nu-3 did not cause significant changes in histology, selected serum chemistry, and hematological parameters compared to the controls. Rats administrated with multiple-doses of Nu-3 showed no visible toxic symptoms. Both in vitro and in vivo, Nu-3 exhibited no notable genetic toxicity. Overall, the data suggest that Nu-3 is hypotoxic or nontoxic antimicrobial compound that warrants being further developed for treatingPseudomonas aeruginosainfection.

2004-08-01·Antimicrobial agents and chemotherapy2区 · 医学

Therapeutic Efficacy of “Nubiotics” against Burn Wound Infection by Pseudomonas aeruginosa

2区 · 医学

Article

作者: Wong, Jonathan P. ; Schnell, Glen ; Dale, Roderic M. K.

ABSTRACT:

“Nubiotics” are a novel class of proprietary protonated nucleic acid-based drugs shown to have potent in vitro antibacterial activities against a number of gram-positive and gram-negative bacteria. These nubiotics are evaluated here for their in vivo therapeutic efficacy for the treatment of burn wound infection caused by Pseudomonas aeruginosa . To achieve this, a burn wound infection model was established in mice by using a highly pathogenic burn wound clinical isolate of P. aeruginosa . Lethal doses of the bacteria were determined for two routes of infection (subcutaneous and topical), representing systemic and local forms of infection, respectively. Using this infection model, treatment with nubiotics by various routes of drug administration was evaluated and optimized. A total of 12 nubiotics and their analogues were tested and of these, Nu-2, -3, -4, and -5 were found to be extremely efficacious in the postexposure treatment of burn wound infection (60 to 100% survival rates versus 0% for untreated control [ P < 0.05]). These nubiotics were effective when given either systemically by intravenous and/or subcutaneous administration or given locally to the affected site in the skin by topical application. Treatment by these two routes resulted in almost 100% survival rates and complete eradication of the bacteria from infection sites in the livers, spleens, and blood. These nubiotics were found to be as effective as intravenously administered ciprofloxacin, a potent and broad-spectrum fluoroquinolone. These results suggest that nubiotics may be a promising and effective approach for the treatment of burn wound infection caused by P. aeruginosa .

项与 Bisphosphocin Nu3 相关的新闻（医药）

2026-07-22

·PRNewswire

Lakewood-Amedex Biotherapeutics Highlights Nu-3 Resistance Data in Response to National Action Plan of Presidential Advisory Council on Combating Antibiotic Resistant Bacteria

Nu-3, a Phase 2-ready candidate targeting the treatment of infected diabetic foot ulcers (iDFU), targets disruption of bacterial membranes through a unique, physical mechanism of action and has demonstrated a high barrier to resistance. SARASOTA, Fla., July 22, 2026 /PRNewswire/ -- Lakewood-Amedex Biotherapeutics Inc., (NASDAQ: LABT, the "Company"), a clinical-stage biotechnology company advancing a novel class of potent, fast-acting, broad-spectrum antimicrobials for infectious diseases called the Bisphosphocin® class, today announced resistance data for Nu-3 in alignment with the Presidential Advisory Council on Combating Antibiotic Resistant Bacteria (PACCARB). The 27th Public Meeting of PACCARB convened on June 16, 2026, with discussion focused on the next 5-year iteration of the National Action Plan on Combating Antibiotic-Resistant Bacteria. The plan functions as a roadmap for the U.S. government to combat antimicrobial resistance (AMR) and guides the actions of the federal agencies that interface with AMR. "The rising tide of antimicrobial resistance represents one of the most severe, global crises in modern medicine, making the acceleration of novel therapeutic platforms a foremost priority," said Kelvin Cooper, Ph.D., CEO of Lakewood-Amedex Biotherapeutics. "We are answering this national call to action by advancing our proprietary Bisphosphocin® platform. Our lead candidate, Nu-3, directly aligns with the objectives outlined by PACCARB, by targeting and disrupting bacterial membranes through a unique, physical mechanism of action. Moreover, Nu-3 has demonstrated a high barrier to resistance, positioning it as a highly differentiated candidate with potential to help address these critical national goals, while providing a valuable option for the millions of patients impacted by iDFU." Lakewood-Amedex Biotherapeutics recently announced that Nu-3 does not induce resistance in a serial passage experiment. In additional laboratory profiling, Nu-3 has demonstrated broad spectrum in vitro activity against bacteria with a diverse range of resistance mechanisms, including modifications to the target of the antibiotic, direct metabolism of the agent, and efflux pump mechanisms. Antibiotic target mutation resistance examples include vanA and vanB variants in E. faecalis and E. faecium, mec variants in H. influenzae, S. aureus, S. pneumoniae, rpoB variants in K. pneumoniae, and PBP2x variants in S. pneumoniae. Antibiotic metabolism resistance examples include the β-lactamase variants NDM, ESBL, AmpC, and CRE, in E. cloacae, E. coli, K. pneumoniae, P. aeruginosa, P. mirabilis, and C. freundii, as well as the metabolic pathway variant sul2 in A. baumannii. Efflux variant examples include metal-tetracycline/H+ antiporter in S. epidermis, and the benzalkonium chloride efflux pump in S. marascens. By bypassing these widespread resistance mechanisms, Lakewood-Amedex Biotherapeutic's platform offers a promising therapeutic avenue that directly supports the federal mandate to bolster the pipeline of innovative, resistance-evading anti-infective therapies. About Lakewood-Amedex Biotherapeutics Inc. Lakewood-Amedex Biotherapeutics Inc. (NASDAQ: LABT) is a clinical-stage biotechnology Company developing a novel class of fast-acting, broad-spectrum antimicrobials – the Bisphosphocin® class - to treat infectious diseases and reduce the threat posed by antibiotic-resistant bacterial strains, including MRSA, VRE, and others. For more information, please visit . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding Lakewood-Amedex Biotherapeutics Inc.'s clinical development plans, regulatory strategy, anticipated trial timing, potential regulatory submissions or approvals, and the potential benefits, safety, efficacy and commercial potential of its Bisphosphocin® platform and product candidates. These statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially, including risks that clinical trials may not be initiated, completed or successful on expected timelines or at all; preclinical or clinical results may not be predictive of future results; product candidates may not demonstrate safety or efficacy or receive regulatory approval; and risks related to manufacturing, supply, financing and other matters described in the company's SEC filings, including under "Risk Factors." Forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to update them except as required by law. Contact Investor Relations Tiberend Strategic Advisors, Inc. David Irish (231) 632-0002 [email protected] Media Relations Tiberend Strategic Advisors, Inc. Casey McDonald (646) 577-8520 [email protected] SOURCE Lakewood-Amedex Biotherapeutics Inc. 21% more press release views with Request a Demo

微生物疗法

2026-07-15

·PRNewswire

Lakewood-Amedex Biotherapeutics Announces Preclinical Safety Data Supporting Clinical Dose Selection for Upcoming Phase 2a Trial of Nu-3 Gel

Nu-3 is a gel formulation of a Bisphosphocin® compound targeting the topical treatment of infected diabetic foot ulcers with low likelihood of producing systemic side effects. SARASOTA, Fla., July 15, 2026 /PRNewswire/ -- Lakewood-Amedex Biotherapeutics Inc., (NASDAQ: LABT, the "Company"), a clinical-stage biotechnology company advancing a novel class of potent, fast-acting, broad-spectrum antimicrobials for infectious diseases called the Bisphosphocin® class, announced robust preclinical safety data that establishes a strong foundation for clinical dose selection in its upcoming Phase 2a clinical trial. "These preclinical results are highly encouraging, providing evidence that our Nu-3 gel formulation has the potential to be a safe and effective, topically delivered antimicrobial," said Kelvin Cooper, Ph.D., Chief Executive Officer of Lakewood-Amedex Biotherapeutics. "Safety data confirms that Nu-3 was well-tolerated and did not inhibit wound-healing in the safety study, which gives us confidence in the therapeutic index of Nu-3 as we near the expected initiation of our Phase 2a study." Nu-3 was well tolerated in the FDA-required safety study after administering dose levels substantially higher than the doses selected for the planned Phase 2a trial. Additionally, systemic exposure was very low, as anticipated, suggesting a low potential for systemic side effects. Lakewood-Amedex Biotherapeutics is finalizing preparation of a Phase 2a clinical trial in infected diabetic foot ulcers (iDFU). The combined outcomes of in vitro antimicrobial activity and in vivo activity in animal models of wound infection, as well as the positive safety study outcome, supports the dose selection of 2%, 5%, and 10% gels targeted for evaluation in the upcoming Phase 2a trial. "Based on the preclinical data, including the safety study, the gel formulation of Nu-3 has the potential to be uniquely suited for the treatment of infected diabetic foot ulcers with broad-spectrum efficacy, fast-acting antimicrobial activity, as well as activity against highly resistant bacterial strains and complex biofilms," stated Thomas Balzer, M.D., Ph.D., Chief Medical Officer of Lakewood-Amedex Biotherapeutics. "The selected concentrations are expected to provide sufficient dose response information both for the antimicrobial activity in patients as well as safety and tolerability of Nu-3, as a topical formulation that ensures a localized therapeutic impact with a low risk of systemic side effects." About Lakewood-Amedex Biotherapeutics Inc. Lakewood-Amedex Biotherapeutics Inc. (NASDAQ: LABT) is a clinical-stage biotechnology Company developing a novel class of fast-acting, broad-spectrum antimicrobials – the Bisphosphocin® class - to treat infectious diseases and reduce the threat posed by antibiotic-resistant bacterial strains, including MRSA, VRE, and others. For more information, please visit . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding Lakewood-Amedex Biotherapeutics Inc.'s clinical development plans, regulatory strategy, anticipated trial timing, potential regulatory submissions or approvals, and the potential benefits, safety, efficacy and commercial potential of its Bisphosphocin® platform and product candidates. These statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially, including risks that clinical trials may not be initiated, completed or successful on expected timelines or at all; preclinical or clinical results may not be predictive of future results; product candidates may not demonstrate safety or efficacy or receive regulatory approval; and risks related to manufacturing, supply, financing and other matters described in the company's SEC filings, including under "Risk Factors." Forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to update them except as required by law. Contact Investor Relations Tiberend Strategic Advisors, Inc. David Irish (231) 632-0002 [email protected] Media Relations Tiberend Strategic Advisors, Inc. Casey McDonald (646) 577-8520 [email protected] SOURCE Lakewood-Amedex Biotherapeutics Inc. 21% more press release views with Request a Demo

临床2期微生物疗法

2026-07-07

·lakewoodamedex.investorroom.com

Lakewood-Amedex Biotherapeutics Supports Reintroduction of the PASTEUR Act and Focus on Combating Antimicrobial Resistance

Company highlights its differentiated Bisphosphocin® platform and lead clinical candidate Nu-3 as innovative approaches to addressing microbial infections and the risk of resistance development SARASOTA, Fla., July 7, 2026 /PRNewswire/ -- Lakewood-Amedex Biotherapeutics Inc., (NASDAQ: LABT, the "Company"), a clinical-stage biotechnology company advancing a novel class of potent, fast-acting, broad-spectrum antimicrobials for infectious diseases called the Bisphosphocin® class, announced its support for the reintroduction of the bipartisan Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act, legislation designed to encourage the development of novel therapies to address the growing global threat of antimicrobial resistance (AMR). "Antimicrobial resistance is rapidly becoming one of the greatest threats to global healthcare, making the development of novel anti-infective therapies more important than ever," said Kelvin Cooper, Ph.D., Chief Executive Officer of Lakewood-Amedex Biotherapeutics. "The reintroduction of the PASTEUR Act recognizes the urgent need for innovation in this critically important field. At Lakewood-Amedex Biotherapeutics, we believe our proprietary Bisphosphocin® platform represents exactly the type of differentiated antimicrobial technology needed to help address resistant microbial infections, and we look forward to advancing the development of Nu-3 in patients with infected diabetic foot ulcers." Lakewood-Amedex Biotherapeutics' proprietary Bisphosphocin® class of compounds has been shown in vitro to rapidly kill bacteria through a pH and concentration dependent destabilization of the bacterial cell membrane. This mechanism of action not only leads to high in vitro activity against antibiotic resistant strains, including Methicillin-resistant Staphylococcus aureus (MRSA) and Vancomycin-resistant Enterococci (VRE), but may also lower the probability of resistance development against the Bisphosphocin® class as suggested by initial in-vitro resistance development data. The Company's is preparing to enter Phase 2 clinical development with its lead product candidate, Nu-3, as a topical therapy for infected diabetic foot ulcer (iDFU). iDFUs represent a significant unmet medical need, affecting millions of patients worldwide and often leading to hospitalization and amputation if the infection cannot be controlled in an early stage. The emergence of antibiotic-resistant pathogens has further complicated treatment, underscoring the need for innovative therapeutic options such as Nu-3. About Lakewood-Amedex Biotherapeutics Inc. Lakewood-Amedex Biotherapeutics Inc. (NASDAQ: LABT) is a clinical-stage biotechnology Company developing a novel class of fast-acting, broad-spectrum antimicrobials – the Bisphosphocin® class - to treat infectious diseases and reduce the threat posed by antibiotic-resistant bacterial strains, including MRSA, VRE, and others. For more information, please visit https://lakewoodamedex.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding Lakewood-Amedex Biotherapeutics Inc.'s clinical development plans, regulatory strategy, anticipated trial timing, potential regulatory submissions or approvals, and the potential benefits, safety, efficacy and commercial potential of its Bisphosphocin® platform and product candidates. These statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially, including risks that clinical trials may not be initiated, completed or successful on expected timelines or at all; preclinical or clinical results may not be predictive of future results; product candidates may not demonstrate safety or efficacy or receive regulatory approval; and risks related to manufacturing, supply, financing and other matters described in the company's SEC filings, including under "Risk Factors." Forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to update them except as required by law. Contact Investor Relations Tiberend Strategic Advisors, Inc. David Irish (231) 632-0002 dirish@tiberend.com Media Relations Tiberend Strategic Advisors, Inc. Casey McDonald 646-577-8520 cmcdonald@tiberend.com SOURCE Lakewood-Amedex Biotherapeutics Inc.

微生物疗法临床2期

100 项与 Bisphosphocin Nu3 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16015

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
糖尿病足溃疡	临床2期	美国	Lakewood-Amedex, Inc.	2022-03-11
2型糖尿病	临床2期	美国	Lakewood-Amedex, Inc.	2016-04-01
糖尿病足感染	临床2期	美国	Lakewood-Amedex, Inc.	2016-04-01
糖尿病溃疡	临床2期	美国	Lakewood-Amedex, Inc.	2016-04-01
复杂的尿路感染	临床前	美国	Lakewood-Amedex Biotherapeutics, Inc.	2026-05-01
肺部感染	临床前	美国	Lakewood-Amedex Biotherapeutics, Inc.	2026-05-01
烧伤感染	临床前	美国	Lakewood-Amedex, Inc.	-
肺部疾病	临床前	美国	Lakewood-Amedex, Inc.	-
甲癣	临床前	美国	Lakewood-Amedex, Inc.	-

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05276401 (CTgov)	临床2期	糖尿病足溃疡	3	10% Bisphosphocin Topical Gel (Active)	遞醖淵網膚壓膚艱壓壓 = 夢鏇膚鏇憲鏇獵鹹願鏇製廠範鏇艱遞餘積製糧 (淵淵夢鏇醖積簾餘鏇積, 網繭壓築範繭窪淵醖糧 ~ 醖鹽選齋構簾餘願壓糧) 更多	-	2024-01-30
NCT05276401 (CTgov)	临床2期	糖尿病足溃疡	3	Placebo Topical Gel (Placebo)	遞醖淵網膚壓膚艱壓壓 = 鬱繭鏇廠鹽繭壓顧顧窪製廠範鏇艱遞餘積製糧 (淵淵夢鏇醖積簾餘鏇積, 遞築廠襯壓遞願鹹觸網 ~ 蓋壓襯鏇鬱遞壓鑰製鑰) 更多	-	2024-01-30
NCT02737722 (CTgov)	临床1/2期	2型糖尿病 \| 糖尿病足感染 \| 糖尿病溃疡	31	Placebo	糧製蓋憲淵膚膚醖繭壓 = 襯製膚糧遞鹽襯夢獵選鑰獵膚艱簾淵簾夢網夢 (廠遞壓繭鹽網鹹憲鹹艱, 夢構醖鑰遞齋糧餘衊夢 ~ 顧膚顧壓顧簾艱蓋製餘) 更多	-	2019-11-19