Lakewood-Amedex Biotherapeutics Announces First Patient Dosed in Phase 2a Clinical Trial of Nu-3 for Infected Diabetic Foot Ulcers

The study tests three gel concentrations to inform dose selection; topline data are expected in the first quarter of 2027.

Rhea-AI Summary

Lakewood-Amedex Biotherapeutics (LABT) dosed the first patient in its Phase 2a Nu-3 trial for mildly infected diabetic foot ulcers. The multicenter, single-blinded study evaluates adults with Type 1 or Type 2 diabetes. It tests three concentrations of Nu-3 topical antimicrobial gel: 2%, 5% and 10%. The study is designed to assess safety and efficacy, including whether Nu-3 reduces microbial burden and resolves infection, and to inform dose selection for further development.

Nu-3 is part of the company's Bisphosphocin antimicrobial platform. Professional Education and Research Institute (PERI), a contract research organization with wound care and podiatric clinical research expertise, manages the trial. Lakewood-Amedex expects topline Phase 2a data in the first quarter of 2027. The company expects the program to advance afterward to a Phase 2b study comparing different Nu-3 gel concentrations, given once or twice daily, with placebo.

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On Sep 24, the day this news came out, the latest delayed price for LABT is 1.12% above the previous close. Argus tracked a peak move of +3.1% during the session. Our momentum scanner has recorded 4 alerts for this stock so far that day. The latest delayed price is $1.80. Relative volume is elevated at 2.2x the average.

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Market Context

After the Sep 18 site-readiness update, LABT's reported 24-hour move was 6.99%; that update covered ...

Analysis

After the Sep 18 site-readiness update, LABT's reported 24-hour move was 6.99%; that update covered the same Nu-3 Phase 2a study now advanced to first-patient dosing.

Key Figures

Nu-3 gel concentrations: 2%, 5%, and 10% Topline data timing: First quarter of 2027

Nu-3 gel concentrations

2%, 5%, and 10%

Phase 2a safety and efficacy evaluation

Topline data timing

First quarter of 2027

Phase 2a study

Previous Clinical trial Reports

2 past events · Latest: Sep 18

Same Type 2 events

1. Sep 18

   Trial site readiness

   24h Move

   +7.0%

   Central and site IRB approvals and clinical-site readiness cleared the Phase 2a start.

2. May 12

   CRO agreement

   24h Move

   +1.9%

   PERI agreed to manage Nu-3's Phase 2 program, including planned Phase 2a and 2b studies.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

antimicrobial resistance, single-blinded, dose-finding, placebo

4 terms

antimicrobial resistance medical

"including antimicrobial resistance (AMR)"

Antimicrobial resistance is when microbes such as bacteria, viruses or fungi evolve so that medicines meant to kill them no longer work — like a lock changing so the old key no longer fits. For investors, this increases demand and cost for new treatments, prolongs hospital stays, prompts tougher regulation and can shrink sales of once-effective drugs, affecting pharmaceutical revenues, R&D spending and broader healthcare risk.

single-blinded medical

"multicenter, single-blinded, dose-finding study"

A single-blinded trial is a clinical study design in which the participants do not know which treatment or placebo they are receiving, while the researchers or clinicians do. This reduces the chance that participants’ expectations change how they report symptoms or side effects, helping make results more reliable. Investors care because the blinding level affects how much trust to place in trial data that can influence a company’s regulatory prospects and valuation; it’s like testing a product with users unaware whether they have the real item or a dummy so their reactions are less biased.

dose-finding medical

"multicenter, single-blinded, dose-finding study"

Dose-finding is the early-stage process in drug development that tests different amounts of a medicine to identify the safest and most effective level for patients. Think of it like adjusting a recipe or thermostat to find the setting that delivers the best result without causing harm; for investors, successful dose-finding reduces risk by improving the chance that later trials, regulatory approval, and commercial use will succeed.

placebo medical

"in comparison to placebo"

A placebo is an inactive pill, injection or procedure that looks and feels like the real treatment but contains no therapeutic ingredient, often called a sugar pill. Investors care because comparing a drug to a placebo reveals whether observed benefits come from the medicine itself or from expectation; clear superiority over placebo reduces regulatory and commercial risk, much like a blind taste test proves a new recipe really tastes better.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Initiation of patient dosing marks significant clinical development milestone for Nu-3 and Lakewood-Amedex Biotherapeutics' proprietary Bisphosphocin^® antimicrobial platform

Topline data expected in the first quarter of 2027

SARASOTA, Fla., Sept. 24, 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 the first patient has been dosed in its Phase 2a clinical trial evaluating Nu-3 for the treatment of patients with mildly infected diabetic foot ulcers (iDFU).

The initiation of patient dosing represents a significant milestone for Lakewood-Amedex Biotherapeutics and the clinical advancement of Nu-3, a topically applied antimicrobial gel designed to rapidly eliminate microbes directly at the site of infection while addressing important limitations of conventional treatments, including antimicrobial resistance (AMR). The Phase 2a study is designed to evaluate the safety and efficacy of three concentrations of Nu-3 and inform dose selection for the Company's continued clinical development program. Topline data from the Phase 2a study are expected in the first quarter of 2027.

"Dosing the first patient in this Phase 2a trial represents a significant milestone for Lakewood-Amedex Biotherapeutics and the advancement of Nu-3 as a potential new treatment for infected diabetic foot ulcers," said Thomas Balzer, M.D., Ph.D., Chief Medical Officer and Senior Vice President, Clinical Development of Lakewood-Amedex Biotherapeutics.  "As our lead clinical asset, Nu-3 represents a key value driver for the Company, and this study is expected to deliver an important first clinical proof of concept to guide its development, while providing an opportunity to validate our differentiated Bisphosphocin^® platform."

The Phase 2a trial is a multicenter, single-blinded, dose-finding study evaluating Nu-3 in adult patients with Type 1 or Type 2 diabetes and mildly infected diabetic foot ulcers. The study will evaluate three Nu-3 gel concentrations, 2%, 5%, and 10%, to assess safety and efficacy, including Nu-3's ability to reduce microbial burden and resolve infection. Following this, the program is expected to advance to a Phase 2b study, evaluating different gel-concentrations of Nu-3 as either once-a-day or twice-a-day treatments in comparison to placebo.

"Diabetic foot infections remain an enormous challenge for patients and clinicians, and we continue to need new approaches that can effectively control infection while supporting our broader goal of healing the wound and preserving the limb," said David G. Armstrong, DPM, M.D., Ph.D., Distinguished Professor of Surgery and Neurological Surgery at the Keck School of Medicine of USC and Study Chair for the Phase 2a trial. "Millions of people worldwide are affected by diabetic foot ulcers, yet treatment options for infected wounds remain limited, particularly as antimicrobial resistance makes these infections increasingly difficult to manage. Advancing a locally delivered topical antimicrobial such as Nu-3 through this study is an important opportunity to evaluate a differentiated approach that could ultimately expand the treatment options available to clinicians and patients."

The Phase 2a trial is being managed by Professional Education and Research Institute LLC (PERI), a contract research organization with expertise in wound care and podiatric clinical research. PERI is led by Charles Zelen, DPM, FACFAS, a practicing podiatrist with deep ties to the diabetic foot care community. The organization's established network of investigators and access to relevant clinical sites is expected to support efficient patient recruitment and high-quality data generation.

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 

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SOURCE Lakewood-Amedex Biotherapeutics Inc.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

When does Lakewood-Amedex Biotherapeutics expect results from its Phase 2a Nu-3 trial?

Lakewood-Amedex Biotherapeutics expects topline data in the first quarter of 2027 from its Phase 2a study of Nu-3 for mildly infected diabetic foot ulcers.