Nu-8 (Cystic Fibrosis)
Cystic fibrosis (CF) is a progressive genetic disease that results in persistent lung infections and limits the ability to breathe over time. Patients with CF have a defective gene that causes a thick buildup of mucus in the lungs, pancreas and other organs. In the lungs, the mucus clogs the airways and traps bacteria leading to lung infections, extensive lung damage and eventually, respiratory failure.
According to the Cystic Fibrosis Foundation Patient Registry, there are more than 30,000 people living with CF in the United States, and more than 70,000 worldwide. Approximately 1,000 new cases of CF are diagnosed each year, with more than 75% of patients diagnosed by age 2.
Cystic fibrosis patients are frequently exposed to multiple doses of antibiotics, eventually giving rise to multidrug-resistant bacteria such as Pseudomonas aeruginosa and methicillin-resistant Staph aureus (MRSA) which become increasingly difficult to control and treat, emphasizing the need for novel bactericidal treatments.
Multidrug-resistant pathogens remain a major clinical problem in patients with CF. Nu-8 aerosol formulation has very broad-spectrum activity as an antimicrobial agent and is also fungicidal. The lack of bacterial resistance development to Nu-8 is particularly important in CF patients where intermittent treatment over the course of two or more decades is the expected norm. After completing preclinical work Lakewood-Amedex plans to initiate and conclude a Phase 1 trial of Nu-8 with inhaler device delivery in healthy volunteers by mid-2020. A Phase 2a dose-escalating trial is then expected to begin in Q3 2020.