Mikrobiomik

Mikrobiomik is a biopharmaceutical company born for the research, development, production and commercialization of biologic medicines based on the human microbiome.

At Mikrobiomik we are developing a new generation of biologic medicines based on the human microbiome, focused on serious diseases, currently with no therapeutic alternative.

The ICD-01 Phase III clinical trial has completed patient recruitment in November 2023, with clinical results which demonstrate the efficacy and safety of the investigational biological medicine, MBK-01, for the treatment of patients with Clostridioides difficile intestinal infection, both for primary episodes and recurrences.

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Vision

Saving lives by leading the research and development of biologic medicines based on the human microbiome.

Mision

Mikrobiomik aims to be the first company worldwide to launch in the EU the first gut microbiota-based biologic medicine, FSPIM (Full Spectrum Purified Intestinal Microbiota), MBK-01, in an innovative freeze-dried gut microbiota capsule format for oral administration.

See Pipeline

Values

Commitment

Each member of the team is committed to find therapeutic alternatives for life-threatening diseases, always from the perspective of solutions based on the human microbiome.

01

Leadership

We plan to lead the paradigm shift of commercializing the first gut microbiota-based biologic medicine in Europe.

02

Research

Research is part of our DNA, part of our culture. We spend a large part of our resources looking for new indications, with the aim of feeding our biologic medicine pipeline.

03

Excellence

We are committed to excellence in all our processes. We produce under GMP (Good Manufacturing Practices), implement rigorous quality controls and select our donors meticulously.

04

Team

Mikrobiomik is formed by a team of expert and multidisciplinary professionals, mostly composed of highly qualified women. Always focused on being the first company worldwide to commercialize in the EU, the first biologic medicine based on fecal microbiota, in the indication of Clostridium difficile.

“Being part of Mikrobiomik means breathing innovation and development.”

Solana P.Mikrobiomik Team
Patricia del Río - Mikrobiomik
Executive Director

Patricia del Rio

Degree in Biochemistry, Master in Cell Biology, Quality and Pharmaceutical Processes and PhD in Molecular Biology and Biomedicine.

“I love being able to transfer scientific knowledge to the development of therapies that help patients and society . Passionate about the sea, the sun and good food. The most international bilbaína of Mikrobiomik!”

Emma López - Mikrobiomik
Head of Quality Assurance - QP

Emma López

Degree in Pharmacy- Master’s degree in medicine R&D&I.

“I am in charge of the Quality Guarantee department and my signature phrase is “this is change control.”

Antonio Martínez
QP Deputy

Antonio Martínez

Doctor of Pharmacy / Official Master’s Degree in Research, Development, Control and Innovation of Medicines.

Solana Pinilla - Mikrobiomik
Finance and HR Manager

Solana Pinilla

Degree in business administration- master in digital marketing.

“Being part of Mikrobiomik is like breath innovation and development the all time”.

Olaia Aurtenetxe - Mikrobiomik
Head of clinical research

Olaia Aurtenetxe

Degree in Biology, PhD in Molecular Biology and Biomedicine, Master in Basic and Clinical Oncology and Master in Clinical Trials.

“Science is always worth it, it is a challenging career that requires a lot of effort and dedication, therefore, I never stop challenging myself and learning”.

Ziortza Ispizua - Mikrobiomik
Production manager

Ziortza Ispizua

Senior Analysis and Control Technician.

“I am the McGyber of the company, I have a thousand stories behind my back that I solve with a cup of coffee in my hand. I safeguard the company’s Iberian secret and I like artificial intelligence”.

Nerea Rodríguez- Mikrobiomik
Quality control manager

Nerea Rodríguez

PhD in biology

“Optimistic and positive to the core, I feed on nature and sports. My phrase “Nankurunaisa al poder”.

Carlota Dopico -Mikrobiomik
Head of Business Development & Innovation

Carlota Dopico

Pharmacist degree – Master in Marketing and Sales Management.

Carolina Sánchez Pastor - Mikrobiomik
QC Technician

Carolina Sánchez

Bachelor’s Degree in Clinical and Biomedical Laboratory and in Analysis and Quality Control Laboratory.

Astrid Villacorta - Mikrobiomik
Donor manager

Astrid Villacorta

Biology degree and production lab technician.

“I’m a multitasker, I process, store and chase donors, plus I always love a good chit-chat.”

Marta González - Mikrobiomik
Production Technician

Marta González

Clinical and Biomedical Laboratory Technician.

Jessica Arribas Suárez- Técnico de Producción
Manufacturing Technician

Jessica Arribas

Senior Clinical Diagnostic Laboratory Technician.

Carlota Gómez
Clinical Advisor

Carlota Gómez

Bachelor’s Degree in Medicine. Master’s Degree in Infectious Diseases. Master’s Degree in Advanced Clinical Care in Infectious Diseases.

ADVISORS

Javier Crespo, colaborador de Mikrobiomik
Professor of Medicine and Head of Service at the Marqués de Valdecilla University Hospital

Javier Crespo

Professor of Medicine and Head of Service at the Marqués de Valdecilla University Hospital.

” Full-spectrum hepatologist and, now, twitterer.”

Rosa del Campo - Mikrobiomik
Doctor of Medicine and Surgery and Miguel Servet researcher stabilized

Rosa del Campo

Doctor of Medicine and Surgery and Miguel Servet researcher stabilized.

“Playing with bacteria to improve health.”

Jesús García-Foncilla, colaborador de Mikrobiomik
Director, Cancer Institute and Department of Oncology, Fundación Jimenez Diaz University Hospital, Autonomous University, Madrid

Jesús García-Foncillas

Director, Cancer Institute and Department of Oncology, Fundación Jimenez Diaz University Hospital, Autonomous University, Madrid.

“Only constant work beyond failure leads you to see the horizon that research brings you”.

Sergio Serrano, colaborador de Mikrobiomik
PhD- Department of Infectious Diseases, Hospital Universitario Ramón y Cajal, Madrid, and Institute for Health Research Ramón y Cajal (IRYCIS).

Sergio Serrano

PhD- Department of Infectious Diseases, Hospital Universitario Ramón y Cajal, Madrid, and Institute for Health Research Ramón y Cajal (IRYCIS).

BOARD MEMBERS

Guillermo Marco-Gardoqui

Co-founder at Mikrobiomik. Vice President of Operations at Grifols.

Antonio Martínez-Martínez

Co-founder at  Mikrobiomik. President in Grifols Diagnostic Division.

Juan Pedro López Araguas

Extensive experience in the Biotechnological Industry, as Director of Proteomika, COO of Progenika in the USA, Senior Advisor in the Energy and Risk Management Sector, and as Director of the country’s Health Cluster.

Facilities

Oficinas Mikrobiomik

OFFICES

Our offices are located in the BIC Bizkia intelligent building.

Mikrobiomik laboratory

LABORATORY

Clean room (Grade C) designed for pharmaceutical production, adapted to meet GMP standards.

Timeline

2018

  • May: Founding of the company.
  • July: Exclusive license agreement with IiSGM (Instituto de investigación sanitaria Gregorio Marañon), on Know How and technology of TMF (gut microbiota transplantation).
  • July: The European Medicines Agency (EMA) gives us the SME qualification.
  • December: Mikrobiomik receives a total of 193.000€ in grants for its R&D costs.

2019

  • March: Pharmaceutical development of “MBK-001” begins.
  • April: Orza (Bioincubadora Bic Bizkaia) enters the capital with a contribution of 400.000€.
  • May: We move to the new location in the Bic Vizcaya incubator building.
  • December: We raise €291,000 in R&D grants.

2020

  • January: We receive the NEOTEC grant for 250,000 €.
  • March: The AEMPS (Spanish Agency for Medicines and Medical Devices) certifies our GMP (Good Manufacturing Practices) facilities, authorizing the manufacture of our first investigational biologic medicine MBK-01.
  • July: Design of the first clinical trial for evaluation by the AEMPS (Spanish Agency of Medicines and Health Products).
  • November: CEBEK (Business Confederation of Bizkaia) gives us the “CEBEK Emprende 2020” award (unanimous decision of the jury).
  • December: We obtained €188,000 in R&D grants.

2021

  • March: First meeting with our Scientific Advisory Board.
  • May: Start the KAPEDIS trial, phase II of MBK-01 vs. placebo.
  • November: Start the ICD-01 trial, phase III of MBK-01 vs. fidaxomicin.
  • December: Following AEMPS approval, Mikrobiomik supplies its first compassionate use of MBK-01.
  • December: We obtained € 117,000 in R&D grants.

2022

  • January: We started investigations with potential partners with the aim of granting a license to commercialize MBK-01.
  • March: Expansion of 4 new centers in the ICD-01 trial.
  • April: Study KAPEDIS ongoing.
  • May: We protect our IP under Blockchain trade secret.
  • June: Authorization with conditions from AEMPS for EMOTION study.
  • August: Authorization request to the AEMPS for the proof of concept in metastatic cancers.

2023

  • January: Signed a framework collaboration agreement with IRYCIS ( Institute Ramón y Cajal for Health Research).
  • February: New Company Award granted by El Correo and Bank Sabadell.
  • March: Presentation of intermediate results of the ICD-01 clinical trial.
  • June: Toribio Echeverria Award for best “Idea/Project”.
  • July: SME of the Year Award granted by Bank Santander for Social Responsibility.
  • July: The EMA (European Medicines Agency) defines MBK-01 as a new active substance and grants Mikrobiomik the option to submit the regulatory dossier. through a centralized process.
  • September: Capital increase of actual partners.
  • October: Closure of patient recruitment for ICD-01 clinical trial.
  • November: Early conclusion of the ICD-01 Phase III clinical trial, as statistically significant results were achieved before recruitment was completed, in the second interim analysis.

2024