NTC, an international pharmaceutical company, has announced positive results from its Phase II MIRAKLE study, evaluating NTC014 for the treatment of bacterial conjunctivitis. The study, a multicenter, randomized, blinded-assessor, non-inferiority trial, assessed the efficacy and tolerability of NTC014 (a quinolone antibiotic + NSAID in eye drops solution) in adult patients.
Key Findings from the MIRAKLE Study
Despite being administered at a lower dosage (25% less antibiotic) than the antibiotic comparator, NTC014 demonstrated non-inferiority in microbiological eradication. Notably, the drug exhibited unexpected efficacy against pathogens classified as intermediate or resistant to the quinolone antibiotic under study.
Alessandro Colombo, Chief Scientific Officer at NTC, stated, "These interim findings reaffirm that NTC014 is eligible to be a new treatment for bacterial conjunctivitis. We aim at demonstrating with robust clinical evidence value and potential for NTC014, considering also that this drug responds to our mission to contribute to fighting antibiotic resistance by using less antibiotics, for a shorter treatment duration with no limitation of usage, also in case of non-confirmation of bacterial etiology."
Addressing Unmet Needs in Conjunctivitis Treatment
Bacterial conjunctivitis is a common eye infection, particularly prevalent in children, accounting for 50%-75% of cases. Riccardo Carbucicchio, Chief Executive Officer at NTC, highlighted the potential of NTC014 to address the significant unmet medical need for effective treatments, especially in moderate-to-severe cases. "We are encouraged by the overall results of the Mirakle study. NTC 014 is first in class combination worldwide of an antibiotic and an NSAID. Given the significant unmet medical need, NTC014 aims to provide physicians with an effective treatment for moderate-severe bacterial conjunctivitis, a common eye infection."
Future Plans for NTC014
NTC aims to finalize commercial partnering for NTC014 in most countries by the end of 2025 and is also considering developing the asset for surgical use. The company has a track record of successful ophthalmological products, including a quinolone and steroid combination for post-cataract surgery, licensed in nearly 90 countries and marketed in 60 countries across Europe, Asia, the Americas, and Africa.
