27 Sep Lakewood-Amedex Inc. Reports Positive Top-Line Data from Randomized Controlled Phase 1/2a Trial of Nu-3 Antimicrobial in Patients with Infected Diabetic Foot Ulcers
SARASOTA, Fla., Sept. 27, 2017 /PRNewswire/ — Lakewood-Amedex Inc., a leading developer of novel anti-infective pharmaceuticals, today announced it will present at the BioPharm America Conference top-line Phase 1/2a clinical data for its lead program, topically applied Nu-3 antimicrobial, to eliminate infection and promote wound healing in patients with infected diabetic foot ulcers (DFU). Nu-3, which belongs to a proprietary class of antimicrobials called Bisphosphocins®, was well-tolerated in this clinical trial, with no reported adverse events related to treatment. Median wound area reduction (change from baseline) was 65.5% in the 2% Nu-3 treatment arm, versus 29.9% in the placebo arm.
Dr. Alexander Reyzelman, Principal Investigator of the study, Associate Professor in the Department of Medicine at the California School of Podiatric Medicine at Samuel Merritt University, and Co-director of the UCSF Center for Limb Preservation stated, “This new class of antimicrobials is very interesting and has significant implications in our treatment of infected diabetic foot ulcers and wounds. The Phase 1/2a clinical data is very promising and I look forward to seeing the data from the next phase of the clinical trial.”
Steve Parkinson, Lakewood-Amedex’s CEO and President, said, “We are very pleased with the safety and tolerability profile of Nu-3, and while the study was not powered to show efficacy, we are excited by the positive trends that we see. We believe the development of this novel antimicrobial will be critical in the fight against serious antibiotic-resistant bacterial infections, both Gram-positive and Gram-negative. Having demonstrated the safety and tolerability of Nu-3 and based on the encouraging results in the Phase 1/2a trial, we are progressing with our formulation of Nu-3 into a commercially-viable topical hydrogel at concentrations of 2% and greater and will continue into the next phase of DFU clinical studies.”
The randomized, multi-center, double-blind, placebo-controlled Phase 1/2a clinical trial was designed as a dose-escalating study to evaluate the safety and tolerability of topically applied Bisphosphocin Nu-3 in patients with Type I or II diabetes mellitus and an infected DFU. The study met its primary endpoints of safety and tolerability, and showed a dose-dependent efficacy trend. Future trials will use hydrogel formulations of Nu-3 at escalating concentrations.
About Lakewood-Amedex Inc.
Lakewood-Amedex is a clinical stage pharmaceutical company developing a broad portfolio of anti-infective products, including first-in-class antimicrobial compounds. The Company’s products and technology are covered by an extensive patent portfolio consisting of over 60 granted and/or issued patents and 6 pending patent applications covering many major pharmaceutical markets. The Company’s lead therapeutic candidate is a novel synthetic broad-spectrum antimicrobial proven to be effective in killing a wide range of Gram-positive, Gram-negative and antibiotic-resistant bacteria and has recently completed a Phase 1/2a clinical trial in patients with infected diabetic foot ulcers (iDFU).
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