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]

NCT02737722

/ Completed临床1/2期

A Phase I/IIa, Randomized Double Blind, Placebo-Controlled, Dose Escalating Study to Evaluate the Safety and Tolerability of Topically Applied Bisphosphocin Nu-3 on Infected Diabetic Ulcers of Subjects With Type I or II Diabetes Mellitus

Phase I/IIa, five cohort ascending dose with two dosing arms per cohort, study in Type I or II diabetes mellitus subjects with a chronic infected diabetic ulcer defined as having a DUSS score of 0 to 3 and DFI wound score of 1 to 3.

开始日期2016-04-01

申办/合作机构

Lakewood-Amedex, Inc.

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.

2011-01-01·Annals of clinical microbiology and antimicrobials3区 · 医学

Antimicrobial activity and mechanism of action of Nu-3, a protonated modified nucleotide

3区 · 医学

ArticleOA

作者: Sun, Lun-Quan ; Cao, Shanping ; Wang, Ming

Abstract:

Background:

"Nubiotics" are synthetic oligonucleotides and nucleotides with nuclease-resistant backbones, and are fully protonated for enhanced ability to be taken up by bacterial cells. Nu-3 [butyl-phosphate-5'-thymidine-3'-phosphate-butyl], one of the family members of Nubiotics was efficacious in the treatment of burn-wound infections by Pseudomonas aeruginosa in mice. Subsequent studies revealed that Nu-3 had a favorable toxicological profile for use as a pharmaceutical agent. This study evaluated the antibacterial activity of Nu-3 in vitro and its efficacy as a topical antibiotic. In addition, we investigated the possible mechanisms of Nu-3 action at the levels of DNA synthesis and bacterial membrane changes.

Methods:

Antimicrobial minimum inhibitory concentrations (MIC) experiments with Nu-3 and controls were measured against a range of Gram-positive and Gram-negative bacteria, including some hospital isolates according to Clinical and Laboratory Standards Institute (CLSI) guidelines. Analysis of the killing kinetics of Nu-3 was also performed against two strains (Staphylococcus aureus cvcc 2248 and Pseudomonas aeruginosa cvcc 5668). The mouse skin suture-wound infection model was used to evaluate the antibacterial activity of Nu-3. We used a 5-Bromo-2'-deoxy-uridine Labeling and Detection Kit III (Roche, Switzerland) to analyze DNA replication in bacteria according to the manufacturer's instruction. The BacLight™ Bacterial Membrane Potential Kit (Invitrogen) was used to measure the bacterial membrane potential in S. aureus.

Results:

Nu-3 had a wide antibacterial spectrum to Gram-positive, Gram-negative and some resistant bacteria. The MIC values of Nu-3 against all tested MRSA and MSSA were roughly in a same range while MICs of Oxacillin and Vancomycin varied between the bacteria tested. In the mouse model of skin wound infection study, the treatment with 5% Nu-3 glycerine solution also showed comparable therapeutic effects to Ciprofloxacin Hydrochloride Ointment. While Nu-3 had no effect on DNA synthesis of the tested bacteria as demonstrated in a BrdU assay, it could cause bacterial cell membrane depolarization, as measured using a BacLight™ Bacterial Membrane Potential Kit.

Conclusions:

These results provide additional experimental data that are consistent with the hypothesis that Nu-3 represents a new class of antibacterial agents for treating topical infections and acts via a different mechanism from conventional antibiotics.

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.

项与 Bisphosphocin Nu3 相关的新闻（医药）

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

2026-06-25

·lakewoodamedex.investorroom.com

Lakewood-Amedex Biotherapeutics Announces World-Renowned Expert David G. Armstrong, M.D., Ph.D., as Study Chair for Phase 2a Trial of Nu-3 in Infected Diabetic Foot Ulcers

Leading clinician and surgeon to also serve as Scientific Advisor for Lakewood-Amedex Biotherapeutics' iDFU program SARASOTA, Fla., June 25, 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 that David G. Armstrong, DPM, M.D., Ph.D., Distinguished Professor of Surgery and Neurological Surgery at the Keck School of Medicine of USC, has accepted the position of Study Chair for the Company's Phase 2a clinical trial evaluating Nu-3 for the treatment of infected diabetic foot ulcers (iDFUs). Dr. Armstrong will also serve as a Scientific Advisor to Lakewood-Amedex Biotherapeutics on the iDFU program. Dr. Armstrong is internationally recognized as one of the world's foremost experts in diabetic foot care, including infection control, wound healing and limb preservation. Throughout his distinguished career, he has authored hundreds of peer-reviewed scientific publications and has helped shape modern approaches to preventing amputations and improving outcomes for patients with diabetes-related complications. "We are honored to welcome Dr. Armstrong as Study Chair for our Phase 2a trial and as a Scientific Advisor to Lakewood-Amedex Biotherapeutics," said Thomas Balzer, M.D., Ph.D., Chief Medical Officer of Lakewood-Amedex Biotherapeutics. "Dr. Armstrong's unparalleled experience as both a surgeon and investigator in national and international clinical trials brings an important perspective to the study and our advancement of Bisphosphocin® antimicrobials. We look forward to working closely with him to evaluate the potential of Nu-3 and to further our understanding of how our novel topical antimicrobial therapies may help address persistent challenges in diabetic foot infection management." As Study Chair, Dr. Armstrong will provide scientific leadership and oversight for the Phase 2a study, helping guide the clinical evaluation of Nu-3, Lakewood-Amedex Biotherapeutics' lead Bisphosphocin® antimicrobial candidate. The Phase 2a clinical trial is a proof-of-concept study designed to evaluate the safety and efficacy of topical Nu-3 gel in patients with infected diabetic foot ulcers. The study will evaluate three dose concentrations of Nu-3 (2%, 5% and 10%) and is intended to support advancement into a larger Phase 2b clinical study. "Infected diabetic foot ulcers are a significant clinical challenge despite advances in wound care and limb preservation, and antibiotic resistance is a potentially grave concern in this patient population," said Dr. Armstrong. "There remains a substantial need for new therapeutic approaches that can effectively address infection while supporting healing and minimizing the risk of developing resistance. A topical antimicrobial such as Nu-3 fits well with the ongoing evolution of diabetic foot ulcer management, and if clinical studies demonstrate its effectiveness, it has the potential to help address an important treatment gap for patients suffering from these serious infections. I look forward to working with Lakewood-Amedex Biotherapeutics to evaluate the potential of this novel therapeutic approach." About David G. Armstrong, DPM, M.D., Ph.D. David G. Armstrong, DPM, M.D., Ph.D., is Distinguished Professor of Surgery and Neurological Surgery at the Keck School of Medicine of USC and a globally recognized leader in diabetic foot care, wound healing and limb preservation. His research and clinical work have focused on preventing amputations and improving outcomes for patients with diabetes-related complications. Dr. Armstrong has authored hundreds of peer-reviewed scientific publications and is widely regarded as one of the most influential voices in the field of diabetic foot disease and limb preservation. 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.

临床2期高管变更

2026-06-16

·lakewoodamedex.investorroom.com

Lakewood-Amedex Biotherapeutics to Present at Life Sciences Virtual Investor Forum

SARASOTA, Fla., June 16, 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 that Kelvin Cooper, Ph.D., Chief Executive Officer and Senior Vice President of Research, will present at the Life Sciences Virtual Investor Forum on June 25, 2026. Presentation Details: Event: Life Sciences Virtual Investor Forum Date/Time June 25, 2026, at 11:30, AM EDT Website Registration Link Event: Life Sciences Virtual Investor Forum Date/Time June 25, 2026, at 11:30, AM EDT Website Registration Link "We look forward to presenting Lakewood-Amedex Biotherapeutics' growth strategy and the ground-breaking potential of our lead candidate, Nu-3, a topical gel being developed for the treatment of infected diabetic foot ulcers (iDFU)," said Kelvin Cooper, Ph.D., Chief Executive Officer and Senior Vice President of Research and Development. "Mild iDFU impacts millions of people worldwide, potentially leading to serious infections and ultimately amputations. As we advance Nu-3 into Phase 2 clinical trials, we believe there is an opportunity to generate substantial value given the drug's unique mechanism of action and its potential to address a large and underserved patient population." 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.

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

10 条进展最快的记录,

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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)	衊鏇餘獵糧製築壓築艱 = 廠夢構觸窪廠壓廠蓋遞構顧廠廠蓋廠範淵蓋鹹 (簾築繭憲艱齋膚鏇願鬱, 襯願顧淵淵齋廠淵醖鑰 ~ 餘夢淵夢築範鬱艱鏇鏇) 更多	-	2024-01-30
NCT05276401 (CTgov)	临床2期	糖尿病足溃疡	3	Placebo Topical Gel (Placebo)	衊鏇餘獵糧製築壓築艱 = 壓範鑰觸蓋築簾廠築選構顧廠廠蓋廠範淵蓋鹹 (簾築繭憲艱齋膚鏇願鬱, 窪構簾醖壓範鬱顧繭顧 ~ 憲憲醖繭網膚鏇鏇積醖) 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	範齋夢製醖範襯襯網齋 = 餘膚簾膚鏇壓製艱願餘鬱簾獵壓遞遞鬱齋觸繭 (膚鏇膚醖壓網窪糧選夢, 鏇艱齋築糧遞鏇範選構 ~ 鑰膚憲積築壓遞憲壓憲) 更多	-	2019-11-19