Lakewood-Amedex Biotherapeutics Announces IRB Approval and Clinical Site Readiness to Initiate Phase 2a Clinical Trial of Nu-3 for the Treatment of Infected Diabetic Foot Ulcers
Lakewood-Amedex Biotherapeutics (LABT) received central and site IRB approvals and confirmed clinical site readiness to begin a Phase 2a trial of Nu-3 for mildly infected diabetic foot ulcers.
Rhea-AI Summary
Lakewood-Amedex Biotherapeutics (LABT) received central and site IRB approvals and confirmed clinical site readiness to begin a Phase 2a trial of Nu-3 for mildly infected diabetic foot ulcers. The study will evaluate the safety and efficacy of Nu-3, the company’s lead product candidate, in patients with iDFU, a condition described as a leading cause of lower-limb amputations worldwide. The trial is designed to build on positive preclinical safety data and early exploratory findings in which Nu-3 was well-tolerated and showed trends of improved antimicrobial response and wound healing. Nu-3 is a proprietary topical gel that uses a mechanism of action aimed at destabilizing microbial cell membranes, which is described as providing a high barrier to the development of antimicrobial resistance. The company states that this development remains aligned with federal mandates from the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria for innovative, resistance-evading therapies.
Positive
- None.
Negative
- None.
Details
Market reaction after Phase 2a clinical trial: LABT +3.55%
Following this news, LABT has gained 3.55%, reflecting a moderate positive market reaction. Our momentum scanner has triggered 2 alerts so far, indicating moderate trading interest and price volatility. The stock is currently trading at $1.93. Trading volume is exceptionally heavy at 9.3x the average, suggesting very strong buying interest.
Data tracked by StockTitan Argus (15 min delayed). Upgrade to Gold for real-time data.
Previous Clinical trial Reports
-
PERI was selected as CRO for the Nu-3 Phase 2 clinical program.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
irb regulatory
amr medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
"Together, these milestones mark another significant step forward in the company's clinical development strategy to address the urgent medical need for new treatments for drug-resistant wound infections," said Thomas Balzer, M.D., Ph.D., Chief Medical Officer of Lakewood-Amedex Biotherapeutics. "With the guidance of our Study Chair, the world-renowned expert Dr. David G. Armstrong, we are well-positioned to evaluate how Nu-3 can potentially improve patient outcomes in the management of iDFU, a condition that impacts millions of lives worldwide and remains a leading cause of lower-limb amputations."
The Phase 2a trial is designed to build upon positive preclinical safety data and early exploratory results, which demonstrated that Nu-3 was well-tolerated and showed trends of improved antimicrobial response and wound healing. The company remains committed to aligning its development efforts with the federal mandates set forth by the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB) by providing innovative, resistance-evading therapies. Nu-3, a proprietary topical gel formulation, utilizes a unique mechanism of action that destabilizes microbial cell membranes, offering a high barrier for bacteria to the development of antimicrobial resistance (AMR) against it.
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
View original content to download multimedia:https://www.prnewswire.com/news-releases/lakewood-amedex-biotherapeutics-announces-irb-approval-and-clinical-site-readiness-to-initiate-phase-2a-clinical-trial-of-nu-3-for-the-treatment-of-infected-diabetic-foot-ulcers-302883237.html
SOURCE Lakewood-Amedex Biotherapeutics Inc.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What is Nu-3 and how is it intended to work?
Nu-3 is described as the lead product candidate of Lakewood-Amedex Biotherapeutics and is formulated as a proprietary topical gel. It is said to utilize a unique mechanism of action that destabilizes microbial cell membranes, which the company states offers a high barrier to bacteria developing antimicrobial resistance against it.
What prior data is the Phase 2a Nu-3 trial building upon?
The Phase 2a trial design builds on positive preclinical safety data and early exploratory results in which Nu-3 was reported to be well-tolerated and to show trends of improved antimicrobial response and wound healing.
How does this Nu-3 program relate to federal efforts on antibiotic resistance?
The company states it is aligning its development efforts for Nu-3 with mandates from the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria by pursuing innovative therapies that aim to evade antimicrobial resistance.