San Diego, California, U.S., September 24, 2026
Lakewood-Amedex Biotherapeutics has announced that the first patient has been dosed in its Phase 2a clinical trial of Nu-3, an investigational antimicrobial therapy being evaluated for the treatment of infected diabetic foot ulcers (DFUs). The milestone marks the advancement of Nu-3 into a mid-stage clinical study as the company investigates its potential to address infections associated with diabetic wounds. Diabetic foot ulcers are a serious complication of diabetes and can become difficult to treat when infection develops, creating a need for effective therapeutic approaches that can address microbial infection while supporting wound management. The initiation of the Phase 2a study represents an important step in Lakewood-Amedex’s clinical development program for Nu-3, with the trial expected to generate additional clinical evidence on the investigational therapy and its potential role in treating infected diabetic foot ulcers.
First Patient Dosed in Phase 2a Clinical Study
The first-patient-dosed milestone confirms the clinical transition of Nu-3 into Phase 2a development. The study is designed to evaluate the investigational treatment in patients with infected diabetic foot ulcers, a patient population that can face substantial treatment challenges. Diabetic foot ulcers can result from multiple factors associated with diabetes, including impaired circulation, neuropathy and reduced wound-healing capacity. Once an ulcer becomes infected, treatment can become more complicated and may require antimicrobial therapy, wound care and other clinical interventions. By advancing Nu-3 into a Phase 2a trial, Lakewood-Amedex is seeking to build on earlier development work and assess the therapy in patients with the target condition. Clinical-stage evaluation will provide researchers with additional information about the treatment’s performance and help inform subsequent development decisions.
Nu-3 Targets Infected Diabetic Foot Ulcers
Nu-3 is being developed as an investigational antimicrobial therapy for infected wounds. The development program is focused on the challenges presented by bacterial infection in diabetic foot ulcers, an area of significant clinical interest because persistent or difficult-to-treat infections can contribute to delayed healing and serious complications. The Phase 2a trial provides an opportunity to investigate Nu-3 under controlled clinical conditions and to collect data relevant to its potential therapeutic activity. The study’s progress will be important for determining how the investigational therapy performs in the intended patient population and whether the clinical data support further development. As with any investigational medicine, the potential benefits and risks of Nu-3 will need to be established through clinical evaluation before any conclusions can be drawn regarding its future use.
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Advancing Treatment Options for Diabetic Wound Infections
The development of new therapies for infected diabetic foot ulcers remains an important area of pharmaceutical research. Diabetes can impair several biological processes involved in wound healing, while infection can further complicate recovery and increase the risk of serious outcomes. Conventional management can involve wound debridement, infection control, offloading and other supportive approaches, depending on the patient’s condition. The development of targeted antimicrobial treatments could potentially add another therapeutic option for patients with infected diabetic wounds if clinical studies demonstrate appropriate safety and efficacy. Lakewood-Amedex’s decision to advance Nu-3 into Phase 2a development therefore represents a new stage in the company’s investigation of an antimicrobial approach for this challenging condition.
The Phase 2a first-patient-dosed milestone is an important clinical development event for Lakewood-Amedex Biotherapeutics and its Nu-3 program. The study will provide further evidence about the investigational therapy in patients with infected diabetic foot ulcers and could help determine the next steps in its clinical development. While the therapy remains investigational, continued clinical evaluation will be necessary to establish its safety, efficacy and therapeutic potential. The advancement of Nu-3 highlights ongoing pharmaceutical research aimed at developing new approaches for complicated diabetic wound infections and improving treatment options for patients affected by these challenging conditions.
Source: Lakewood-Amedex Biotherapeutics press release
