#Italy #Milan #NTC014 #bacterial conjunctivitis #Mirakle study

NTC's Mirakle Study: A Step Forward in Treating Bacterial Conjunctivitis

NTC Srl, an international pharmaceutical company based in Milan, Italy, recently unveiled positive outcomes from their Phase II study known as Mirakle, which assesses the efficacy and safety of a novel treatment for bacterial conjunctivitis in adults. This multicenter, randomized, and evaluator-blinded study aims to determine the effectiveness of NTC014, a combination of a quinolone antibiotic and a non-steroidal anti-inflammatory drug (NSAID), administered as eye drops.

Study Overview and Findings

Despite employing a simplified treatment regimen, NTC014 exhibited effective outcomes. The therapeutic protocol involved a lower dosage compared to the conventional antibiotic, with a reduction of 25% in the antibiotic administered. Notably, results displayed that NTC014’s eye drops were not inferior to the antibiotic alone in eradicating bacteria, even against strains recognized as intermediate or resistant to the tested quinolone antibiotic.

Alessandro Colombo, NTC's Scientific Director, expressed satisfaction with the provisional findings, stating, "These provisional outcomes affirm that NTC014 could be a promising candidate for a new bacterial conjunctivitis treatment." He emphasized the importance of producing robust clinical evidence that highlights NTC014’s value in combating antibiotic resistance by minimizing antibiotic usage and shortening treatment duration, thus potentially improving patient outcomes.

Medical Implications and Future Goals

The implications of conjunctivitis, particularly bacterial conjunctivitis, are significant in both economic and social contexts. It’s a common eye infection that, while prevalent in adult populations, disproportionately affects children, accounting for 50% to 75% of cases. NTC aims to address this significant health concern with a treatment that combines useful therapeutic properties from both its antibiotic and NSAID components.

Riccardo Carbucicchio, CEO of NTC, noted, "Given the substantial unmet medical need, NTC014 is designed to provide physicians with an effective treatment option for moderate to severe bacterial conjunctivitis. Our ambition is to finalize commercial partnerships for this asset globally before the close of 2025. Additionally, we do not rule out future potential applications of this asset in surgical scenarios."

Clinical Background

To date, NTC has already achieved recognition in the field by successfully developing and launching the first combination of a quinolone antibiotic and a steroid for postoperative cataract surgery, which has been authorized in approximately 90 countries and is marketed in 60 across Europe, Asia, America, and Africa. NTC’s mission showcases their commitment to research and development in transforming patient care through innovative products across various therapeutic domains, including ophthalmology, pediatrics, gynecology, and gastroenterology.

More information regarding NTC’s initiatives and products can be found on their official website. This groundbreaking study not only represents an advancement in the fight against conjunctivitis but also aligns with the broader public health challenge of antibiotic resistance.

As NTC continues its journey through clinical trials and commercial exploration, the broader healthcare community anticipates further insights into the potential of NTC014 to reshape treatment approaches for bacterial conjunctivitis.