We aspire to be the first company in the world to market a medicine based on faecal microbiota in the EU. To that end, we are holding talks with both the EMA (European Medicines Agency) and the AEMPS (Spanish Agency for Medicines and Health Products) with a view to establishing protocols on the regulatory requirements for securing an MAA (Marketing Authorization Application) via centralised procedure.
Mikrobiomik seeks to lead the paradigm shift entailed by designing therapeutic solutions based on the human microbiome through excellence in its processes, empathising with chronic patients for whom no curative treatments are available, always from the perspective of networking with all stakeholders in the sector.
We provide new solutions waste on the human microbiome for sufferers from serious, chronic diseases for which there is currently no other therapy.
We are developing a new generation of medicines based on the therapeutic potential of the human microbiome.
Mikrobiomik has been awarded an SME (Small and Medium-Size Enterprise) rating by the EMA (European Medicines Agency).
Mikrobiomik has signed an agreement for the transfer of pharmaceutical technology and know-how with the FIBHGM (Biomedical Research Foundation of the Gregorio Marañón Hospital in Madrid) under which its stool bank, which has pioneered faecal microbiota transplants in Spain, will transfer exclusively to Mikrobiomik the knowledge and expertise accumulated over more than five years at the Clinical Microbiology Unit of the Gregorio Marañón Teaching Hospital, a pioneer in the treatment of recurrent Clostridium difficile through faecal microbiota transplantation.
Mikrobiomik has received support from the programme for the creation of innovative new companies run by Beaz, a publicly-owned company and searchable to the Provincial Council of Bizkaia whose goal is to support companies and individual entrepreneurs in their efforts to create new projects, innovate and internationalise. For more than 30 years, Beaz has worked in the definition and management of some of the aids granted by the Provincial Department of Economic and Territorial Development, and offers various services that support business growth.
NEOTEC 2019 / SNEO-20191009 MIKROBIOMIK
Development of new medications based on the human microbiome.
Financed by the CDTI/NEOTEC initiative – Spain’s Ministry of Science and Innovation.
HAZITEK – ENPRESA I+G BULTZATZEKO LAGUNTZA PROGRAMA
EUSKO JAURLARITZAK ETA EUROPAR BATASUNAK
2021-2027 ESKUALDE GARAPENERAKO EUROPAR FUNTSAREN (EGEF) BITARTEZ KOFINANTZATUTAKO ERAGIKETA
Project no. ZL-2021/00139- MBK_01 proiektua
Business R&D support aid program – Hazitek.
Action co-financed by the Basque government and the European Union through the European Regional Development Fund 2021-2027 (ERDF).
MBK-001 PROGRAM: Mechanism of action validation, scale-up of manufacturing process and quality control system optimisation with the aim of introducing this into the European market. The project has been funded by the Diputación Foral de Bizkaia withing the 2i 2021 Program and together with FEDER cofounding.