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Lakewood-Amedex Announces Resistance Data for Nu-3
Lakewood-Amedex Biotherapeutics announced resistance data for Nu-3 in alignment with the Presidential Advisory Council on Combating Antibiotic Resistant Bacteria, or 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, or AMR, and guides the actions of the federal agencies that interface with AMR. 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. 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.
Lakewood-Amedex Announces Robust Preclinical Safety Data for Nu-3
Lakewood-Amedex Biotherapeutics 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, CEO. "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. 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.
Lakewood-Amedex Supports Reintroduction of PASTEUR Act
Lakewood-Amedex Biotherapeutics 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. "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 CEO Says Going Public Boosts Visibility and Engagement
Lakewood-Amedex CEO says going public boosts visibility, engagement
Lakewood-Amedex Biotherapeutics Goes Public, CEO Discusses Bisphosphocin Technology
In an exclusive interview, Lakewood‑Amedex BiotherapeuticsCEO Kelvin Cooper spoke with The Fly about the company, going public, its Bisphosphocin technology, primary objectives, and more.BISPHOSPHOCIN CLASS:Lakewood-Amedex Biotherapeutics is a clinical-stage biotechnology company advancing a novel class of potent, fast-acting, broad-spectrum antimicrobials for infectious diseases called the Bisphosphocin class."The company's proprietary Bisphosphocin technology is designed to work differently than conventional antibiotics by rapidly disrupting microbial membranes, which may help avoid the emergence of resistance to the class and thereby address the growing challenge of antimicrobial resistance. Our lead candidate, Nu-3, is being developed for mildly infected diabetic foot ulcers, a serious condition with significant medical and economic burden worldwide," CEO Kelvin Cooper explained to The Fly.GOING PUBLIC:Lakewood-Amedex Biotherapeutics went public recently. Cooper views the Nasdaq listing as "an important transition for Lakewood-Amedex from a privately held development-stage company into a broader public market story." "Since listing, we've seen increased engagement from investors, industry participants, and potential strategic partners who recognize both the urgency of the antimicrobial resistance crisis and the need for differentiated technologies in the space," the executive added."Being public also provides us with a stronger platform to communicate our scientific progress, expand corporate visibility, and support the continued advancement of our clinical and preclinical pipeline. Importantly, access to the public markets provides the company with greater financial optionality, including a range of capital formation opportunities as we continue executing on our growth strategy."ANTIMICROBIAL FIELD:Antimicrobial resistance is a rapidly evolving global challenge. Lakewood-Amedex Biotherapeutics' CEO believes the antimicrobial field is approaching an inflection point where healthcare systems increasingly need alternatives to traditional antibiotic approaches.The company is "focused on developing antimicrobial compounds designed to attack pathogens through a broad-spectrum mode of action on microbial membranes, rather than targeting a single metabolic pathway. That distinction is important because it may reduce the ability of microbes to adapt and develop resistance over time. Another key differentiator is our localized delivery strategy, which is intended to concentrate antimicrobial activity directly at the infection site while potentially limiting systemic exposure and therefore limiting the common side effects of systemic antimicrobials – gastrointestinal and immunological," Cooper told The Fly."The activity of the class on biofilms that has been shown in vitro, and which are a major contributor to chronic and difficult-to-treat infections, is another differentiating factor if confirmed clinically. Many existing therapies struggle to effectively penetrate biofilms, particularly in chronic wound environments such as diabetic foot ulcers. Taken together, we believe our platform represents a differentiated approach within a market that is increasingly seeking novel anti-infective mechanisms."WHAT'S NEXT:Looking over the next 12 to 18 months, the company's chief executive sees the primary objective as the "continued clinical advancement of Nu-3 in mildly infected diabetic foot ulcers."Lakewood-Amedex Biotherapeutics recently announced plans for a Phase 2a study intended to evaluate multiple gel concentrations ahead of a larger Phase 2b trial. Those studies are designed to further characterize dosing, safety, and clinical activity as we advance the program."Beyond Nu-3, we intend to continue highlighting the broader applicability of the Bisphosphocin platform across additional infectious disease settings where resistant organisms and biofilms represent significant unmet needs such as complicated urinary tract infections and pulmonary infections," the CEO said.NOT JUST ANOTHER ANTIBIOTIC COMPANY:Discussing any potential misconceptions about the company, Cooper told The Fly that the biggest misconception is that Lakewood-Amedex Biotherapeutics is "just another antibiotic company.""We're not developing incremental antibiotics. We're developing a new class of antimicrobials with a mechanism designed to address resistance at a more fundamental level. Our focus on local delivery, biofilm penetration, and broad-spectrum antimicrobial activity differentiates us from many traditional anti-infective developers," the CEO added.Another misconception is that Lakewood-Amedex Biotherapeutics is "centered around a single product candidate." The company views the Bisphosphocin class as a broader platform technology with potential applications across multiple infectious disease indications. "As awareness around antimicrobial resistance continues to increase globally, we believe investors are beginning to appreciate the broader strategic value of differentiated antimicrobial platforms like ours."Meet the Company" is The Fly's recurring series of exclusive short interviews with Executive Officers to offer a deeper look inside the company.
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