In a huge step towards the evolution of medical research, Mikrobiomik, the pioneer company in the human microbiome, has confirmed a capital increase of 1.1 million euros. This milestone happens thanks to the exclusive contribution of its current partners, who are determined to accomplish their initial mission: to launch their investigational biological drug, MBK-01, on the European market.
Since its founding in 2018, Mikrobiomik has raised a significant amount of capital, demonstrating the trust and support of partners, such as Orza and Seed Capital Bizkaia. In addition, 11 other partners, which include family offices and founding partners, have believed in the project since its early days.
Mikrobiomik is currently completing Phase III of its clinical trial ICD-01, with its innovative drug MBK-01, which is compared to the SoC (standard of care) antibiotic fidaxomicin, in the treatment of primary and recurrent Clostridioides difficile infections. Midterm results from the trial have been extremely encouraging, with final results expected to be published by the end of 2023.
Mikrobiomik wants to submit the regulatory dossier for MBK-01 to the European Medicines Agency (EMA) via the centralized pathway as the next step towards a Marketing Authorization Application (MAA).
It is important to note that Mikrobiomik has been providing MBK-01 free of charge through its compassionate use program, benefiting more than 25 patients to date. This solidarity action reflects the company’s commitment to patient health.
Mikrobiomik expects to launch MBK-01 on the European market during the first half of 2025. This biological drug, with FSPIM® (Full Spectrum & Purified Intestinal Microbiota) technology, is supplied in an innovative format of freeze-dried oral capsules of intestinal microbiota. This innovation has the potential to radically change the approach to the treatment of primary and recurrent Clostridioides difficile infections, bringing hope to patients across the European continent.
With this capital increase, they are poised to reach new heights in medical research and significantly improve the lives of those struggling with various diseases with no effective therapeutic alternative. The future of the gut microbiota starts here.