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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.

Our first investigational biological drug, MBK-01, aimed at the treatment of intestinal infection by Clostridioides difficile, has announced the closure of the phase III clinical trial, and patient recruitment has been completed in November 2023. The regulatory dossier will be presented to the EMA (European Medicines Agency) in 2024, via a centralized channel and its commercialization is expected during the first half of 2025.

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.

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
Todo el equipo de Mikrobiomik
Juan Basterra - Mikrobiomik
CEO

Juan Basterra

Degree in Medicine and MBA from the Commercial University of Deusto.

” Hardcore reader, Athletic fan and, on top of that , from the very center of Bilbao”.

Celia Morales - Mikrobiomik
Qualified Person and Quality Control Manager

Celia Morales

Qualified Person and Quality Control Manager.

“To the release of the batch I bring a note of traditional culture with sayings and proverbs.”

Patricia del Río - Mikrobiomik
Business Development & innovation 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!”

Leire Miñón San Miguel - Mikrobiomik
CFO & HR Director

Leire Miñón

“With a smile on my face and a calculator in my hand, as CFO, I manage the numbers and get budgets approved. My passion for travel and beaches is balanced with my ability to keep finances afloat”.

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Olga Shapoval - Mikrobiomik
Medical Director

Olga Shapoval

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”.

Emma López - Mikrobiomik
Quality Assurance Manager

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.”

Patricia Crespo - Mikrobiomik
QC Technician

Patricia Crespo

Degree in Biology – Master in Microbiology and Health.

“Quality Control Technician, passionate about microbiology and life sciences. From Madrid to Euskadi on one way”.

Nerea Rodríguez- Mikrobiomik
QC Technician

Nerea Rodríguez

PhD in biology

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

Carolina Sánchez Pastor - Mikrobiomik
QC Technician

Carolina Sánchez Pastor

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

Usoa Aguilera - Mikrobiomik
Production Technician

Usoa Aguilera

Degree in Chemistry

“Like Antoñita la Fantástica, a little bit of everything: dancing lover and gym fan. Cooking amateur and always with a smile.”

Astrid Villacorta - Mikrobiomik
Production Technician

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.”

Sergio Calvo -Mikrobiomik
Maintenance Manager

Sergio Calvo

Superior Degree on industrial equipment maintenance and a Marine Degree.

Estibalitz Plaza - Mikrobiomik
Quality Assurance Technician

Estibalitz Plaza

Graduate in biochemistry and master’s degree in drug research, development and innovation.

“I chase people to sign the documentation. I love soccer and the Madrid life and as a good Vitoriana, proud to be from the capital of the Basque Country”.

Anne Vázquez del Olmo - Mikrobiomik
Quality Assurance Technician

Anne Vázquez del Olmo

Pharmacist degree – Master’s degree in drug research, development and innovation.

Carlota Dopico -Mikrobiomik
Business Development & Innovation Assistant

Carlota Dopico

Pharmacist degree – Master in Marketing and Sales Management.

Solana Pinilla - Mikrobiomik
Communication & marketing manager

Solana Pinilla

Degree in business administration- master in digital marketing.

“An Argentinian landed in Euskadi, lover of Excel, numbers and fan of digital tools”.

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).

Facilities

Mikrobiomik team - BIC Bizkaia

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

February: Presentation of the final results obtained in the ICD-01 clinical trial, phase III.