Nu-3 is one of a new class of antimicrobial compounds discovered by Lakewood-Amedex Biotherapeutics called the Bisphosphocin® class, which are also being explored in pre-clinical studies as potential treatments for complicated urinary tract infection (cUTI) and pulmonary infections. The Bisphosphocin® class of compounds have been shown in vitro to rapidly kill bacteria through a pH and concentration dependent destabilization of the bacterial cell membrane, typically achieving this effect in under one minute of exposure. This mechanism of action offers the potential to reduce the threat posed by antibiotic-resistant bacterial strains, including Methicillin-resistant Staphylococcus aureus (MRSA), Vancomycin-resistant Enterococci (VRE), and others.

In laboratory studies using a serial passage of E. coli and MRSA in the presence of Nu-3 for 21 days, Nu-3 showed slightly increased Minimum Inhibitory Concentration (MIC) at the end of the experiment for E. coli and were unchanged for MRSA. In contrast, the MIC for the ciprofloxacin control had increased over 2,000-fold for E. coli and over 600-fold for MRSA. In addition, Nu-3 maintained its original MIC when assessed against the bacteria that had developed resistance to Ciprofloxacin, which implies that cross-resistance did not occur.

"In experiments designed to induce resistance, the Bisphosphocin class has maintained its in vitro efficacy and potency, demonstrating a very low potential for resistance development, which confers enormous potential for our Nu-3 candidate targeting iDFU, and more broadly, as we work towards solutions for antimicrobial resistance, a major health challenge for our society," said Kelvin Cooper, Ph.D., Chief Executive Officer at Lakewood-Amedex Biotherapeutics. "Notably, the AMR data support our understanding of the mechanism of the Bisphosphocin® class of compounds, which we believe can provide a broad spectrum of activity against gram-positive, gram-negative, and multidrug-resistant organisms, and would provide a significant advantage over many existing antimicrobial classes."

The global AMR crisis is directly responsible for approximately 1.27 million deaths annually and contributes to nearly 5 million deaths worldwide. "Drug-resistant pathogens are a rising threat that have rendered many existing antibiotics ineffective, leading to increased mortality as well as higher healthcare costs and longer hospital stays," stated Thomas Balzer, MD, Ph.D., Chief Medical Officer and Senior Vice President, Clinical Development. "Of the approximately 830 million people who suffer from diabetes globally, about one third will develop a DFU in their life, of which about 50% will become infected, with many patients experiencing multiple infection events through their lives. We are developing Nu-3 to meet this very large, critically underserved treatment need."

About 15% to 20% of iDFU cases are caused by resistant pathogens, primarily MRSA underscoring the need for rapid and effective treatment in the early stage, including effective elimination of resistant pathogens to prevent disease progression and potentially devastating complications like amputations. For individual with diabetes, infections, especially when left untreated, are a risk factor for amputations, alongside the presence of conditions like peripheral arterial disease. The economic burden of DFU complications is significant, with the cost of care estimated at $80 billion in 2018 in the U.S., comparable to the cost of treating the five most expensive forms of cancer in total.