On November 15th of this year, with our CRO “Sermes”, we informed to the AEMPS (Spanish Agency of Medicines and Sanitary Products) of the EARLY CLOSURE of the ICD-01 Phase III clinical trial, having reached significant statistical results before completing recruitment, during the second interim analysis.
ICD-01 is a randomized, controlled, open-label clinical trial in patients with primary or recurrent Clostridioides difficile (CD) infection to evaluate the efficacy and safety of MBK-01 (freeze-dried intestinal microbiota capsules) versus the gold standard antibiotic fidaxomicin, the final report of the trial will be published in January 2024. This trial started recruiting patients in 2021, and 21 hospitals in Spain have been included during this time.
We have started to prepare the regulatory dossier for our leading product, MBK-01, with the aim of applying to the EMA (European Medicines Agency) for centralized marketing authorization during the second half of 2025. MBK-01 will continue to be supplied under compassionate use until it reaches the market.
With this news we achieved another important milestone for Mikrobiomik.