NTC reports positive Phase II results for new bacterial conjunctivitis drug

MILAN, Dec. 5, 2024 – NTC, a global research-driven pharmaceutical firm based in Italy, has announced promising findings from the Phase II MIRAKLE study. This multicentre, randomized, blinded-assessor trial examined the efficacy and tolerability of NTC014, a combination of a quinolone antibiotic and a nonsteroidal anti-inflammatory drug (NSAID) in eye drop form, for treating bacterial conjunctivitis in adults.

The study demonstrated that despite administering a lower dosage of NTC014—25% less antibiotic compared to the standard antibiotic regimen—the results showed NTC014 was not inferior to the antibiotic alone in achieving microbiological eradication. Remarkably, NTC014 also showed efficacy against pathogens that are typically classified as either intermediate or resistant to the quinolone antibiotic under investigation.

Alessandro Colombo, Chief Scientific Officer of NTC, remarked on these interim results, emphasizing that NTC014 appears to be a strong candidate for treating bacterial conjunctivitis. "Our goal is to substantiate the value and potential of NTC014 through solid clinical evidence," Colombo stated. He highlighted that the drug aligns with NTC’s mission to combat antibiotic resistance by utilizing fewer antibiotics over a shorter treatment duration, without limitations even if bacterial etiology is not confirmed.

Riccardo Carbucicchio, Chief Executive Officer of NTC, expressed optimism about the study's outcomes. He noted that NTC014 represents the first globally available combination of an antibiotic and an NSAID. Given the significant unmet medical need, NTC014 aims to equip physicians with an effective treatment option for moderate to severe bacterial conjunctivitis, a prevalent eye infection. Carbucicchio also mentioned the potential for commercial partnerships to be finalized globally by the end of 2025, and they are considering the development of this asset for surgical applications as well.

Conjunctivitis, commonly known as pink eye, is a widespread condition in Western countries, leading to significant economic and social impacts. While viral conjunctivitis is the most frequent cause of infectious conjunctivitis overall, bacterial conjunctivitis is the second most common cause and accounts for a large proportion of cases in children, ranging from 50% to 75%.

NTC has a history of innovation in ophthalmology. They previously developed and launched a combination of a quinolone antibiotic and a steroid for post-cataract surgery, which has been licensed in nearly 90 countries and is currently available in 60 countries across Europe, Asia, the Americas, and Africa.

NTC is headquartered in Milan, Italy, and partners with distributors in over 100 countries. The company is dedicated to the research, development, registration, and commercialization of pharmaceutical products, medical devices, and food supplements, particularly in the fields of ophthalmology, pediatrics, gynecology, and gastroenterology. NTC collaborates with over 200 partners to provide innovative and high-quality pharmaceutical products.