Lakewood-Amedex has secured approvals to launch a Phase 2a study of Nu-3, its antimicrobial gel, targeting challenging resistant bacteria in diabetic foot ulcers, with clinical expertise brought in to bolster development.
Lakewood-Amedex Biotherapeutics said it has secured the institutional approvals needed to begin a Phase 2a study of Nu-3, its lead antimicrobial candidate, in patients with mildly infected diabetic foot ulcers. The company said the trial will examine the safety and effectiveness of the topical gel in a condition that remains difficult to treat, particularly when bacterial resistance complicates wound care.
The move follows earlier company disclosure in July that preclinical safety work supported the dose selection for the study. Lakewood-Amedex said Nu-3 was well tolerated in laboratory testing and did not hinder wound healing, while also showing activity against resistant bacteria and complex biofilms. That package of data helped clear the way for the next stage of clinical testing.
Public trial listings now indicate the study is recruiting in the United States under the identifier NCT07565506. Those listings describe a randomised, controlled dose-finding trial that will compare 2%, 5% and 10% gel strengths and assess safety, tolerability and antimicrobial effect. Other summaries say the study is expected to involve up to 24 participants, with some databases describing a larger planned enrolment, suggesting the protocol has been presented in more than one form.
Lakewood-Amedex has also brought in Dr David G. Armstrong as study chair and scientific adviser for the programme, according to reporting from BiopharmaWatch. Armstrong, a long-time specialist in diabetic foot care, is expected to lend clinical expertise to a field where treatment options remain limited. For a small, clinical-stage company with no revenue, the trial is a significant milestone: success would not only support Nu-3’s development but also strengthen the case for a platform aimed at drug-resistant wound infections.
Disclaimer: This content is for informational purposes only and is not intended to be a substitute for professional medical judgment, advice, diagnosis, or treatment.
