#Italy #Milan #NTC014 #bacterial conjunctivitis #Phase II Trial

NTC's Phase II Mirakle Study Promises Breakthrough in Bacterial Conjunctivitis Treatment

Recently, NTC, an Italian pharmaceutical company dedicated to research and development, released encouraging results from its Phase II MIRAKLE study. This clinical trial assesses NTC014— a unique combination of a quinolone antibiotic and a non-steroidal anti-inflammatory drug (NSAID) delivered as eye drops—for treating bacterial conjunctivitis in adults.

Bacterial conjunctivitis, a frequent and often troublesome eye infection, poses a significant economic and social challenge in Western countries. It is essential to understand that while viral conjunctivitis is more common, bacterial infections still account for a large number of cases, particularly in children. NTC aims to address this problem by providing a more effective treatment option.

Mirakle Study Overview

The MIRAKLE study was designed as a multi-center, randomized, dual-masked trial to evaluate the efficacy and safety of NTC014 compared to a traditional antibiotic regimen. Notably, despite NTC014 being administered at a reduced antibiotic dosage—25% less than the comparator—it still demonstrated non-inferiority in achieving microbiological eradication from the primary endpoints. In fact, the results were unexpectedly robust, showing efficacy against pathogens that were categorized as medium or resistant to the quinolone antibiotic under study.

Alessandro Colombo, the Chief Scientific Officer of NTC, pointed out, "These preliminary results suggest that NTC014 could be a promising new treatment for bacterial conjunctivitis." He further emphasized NTC's mission to contribute to combating antibiotic resistance by utilizing lower dosages over shorter treatment durations without restriction of use, even in cases where bacterial etiology is unconfirmed.

Insights from NTC’s Leadership

Riccardo Carbucicchio, NTC’s Chief Executive Officer, expressed optimism about the overall findings of the Mirakle study. He noted, "NTC014 is the world’s first formulation combining an antibiotic with an NSAID in this category. Given the significant unmet medical need, it aims to provide physicians an efficient option for treating moderate bacterial conjunctivitis, a common eye infection." He indicated that NTC plans to secure commercial partnerships before the end of 2025 to further the reach of this innovative treatment.

Implications for Bacterial Conjunctivitis Treatment

With the rising concern over antibiotic resistance in recent years, the development of NTC014 could represent a significant advancement in how bacterial conjunctivitis is treated. In addition, NTC has successfully launched a pioneering combination of a quinolone and steroid for post-cataract surgery, which is already approved in almost 90 countries worldwide.

It’s crucial to highlight that bacterial conjunctivitis remains a prevalent condition, especially in younger populations, and the ramifications of untreated infections can lead to complications affecting vision and quality of life. Thus, a reliable treatment option like NTC014 can ease the burden on healthcare systems while improving patient outcomes.

About NTC

NTC is a Milan-based pharmaceutical company, with distributors and partners across over 100 countries, focusing on developing and marketing pharmaceuticals, medical devices, and supplements primarily within ophthalmology and various therapeutic areas, including pediatrics and gynecology. Currently, NTC boasts a portfolio of over 200 innovative pharmaceutical products.

As NTC continues its clinical development journey, stakeholders and healthcare professionals will be eagerly anticipating further results and potential approvals for NTC014, a product that could change the landscape of treatments available for bacterial conjunctivitis.