Lakewood-Amedex backs PASTEUR Act, plans Phase 2 trial for Nu-3
Lakewood-Amedex Biotherapeutics Inc. (NASDAQ: LABT) announced its support for the reintroduction of the bipartisan Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act, legislation aimed at encouraging the development of new therapies to address antimicrobial resistance (AMR).
The clinical-stage biotechnology company said it is preparing to enter Phase 2 clinical development with its lead product candidate, Nu-3, as a topical therapy for infected diabetic foot ulcers (iDFU). The company described iDFUs as a condition affecting millions of patients worldwide and frequently leading to hospitalization or amputation when infections are not controlled at an early stage.
Nu-3 is part of Lakewood-Amedex's proprietary Bisphosphocin® class of compounds, which the company said has shown in vitro activity against antibiotic-resistant bacterial strains, including Methicillin-resistant Staphylococcus aureus (MRSA) and Vancomycin-resistant Enterococci (VRE). The compounds work by destabilizing bacterial cell membranes in a pH- and concentration-dependent manner, according to the company.
"The reintroduction of the PASTEUR Act recognizes the urgent need for innovation in this critically important field," said Kelvin Cooper, Ph.D., Chief Executive Officer of Lakewood-Amedex Biotherapeutics. "We look forward to advancing the development of Nu-3 in patients with infected diabetic foot ulcers."
The company noted that initial in vitro resistance development data may suggest a lower probability of resistance developing against the Bisphosphocin® class, though clinical validation has not yet been completed. The information is based on a company press release.
