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In this informative capsule, we talk about fatotherapy with Marisa Domingo Calap, virologist and CEO of the company Evolving Therapeutics.
Compassionate use treatments
Since the company was founded in 2023, 15 compassionate use treatments have been approved by the Spanish Agency for Medicines and Health Products (AEMPS), most of them for people with Cystic Fibrosis.
All of them have been successful, such as the case of Irene Nevado, which was widely reported in the national media. Irene was at the Puerta de Hierro Hospital awaiting her third double lung transplant due to a bacterial infection she had had since the age of 8, which no medication had been able to eradicate. With phage therapy treatment, Irene was removed from that waiting list and now enjoys a better quality of life.
Regulatory limitations
Right now, Evolving Therapeutics is facing regulatory limitations that prevent them from continuing with compassionate use treatments. Marisa regrets that, despite having validated the effectiveness of the treatment and having the capacity to produce the vials for these individualized treatments, the AEMPS (Spanish Agency for Medicines and Health Products) will not allow them to continue.
Therefore, the only way to overcome this obstacle is to conduct a clinical trial, which costs more than €5 million and takes a long time.
Phage-based compounded medications
However, in countries such as Portugal and Belgium, phage-based compounded medications are used and can be developed in hospital pharmacies, but regulations do not allow this in Spain either. In this regard, patient associations can lobby for phage-based compounded medications to become a reality, as recently happened in Portugal, which would be a welcome course of action.
Evolving Therapeutics
Evolving Therapeutics is made up of the University of Valencia, the Respiralia Foundation, and Doctors Pilar Domingo Calap and Marisa Domingo Calap. This partnership has made it possible to develop a treatment that aims to be a solution to antibiotic-resistant bacteria.
Furthermore, the partnership agreement established that during the first five years, phage treatments in humans would be completely free of charge, so it is incomprehensible that the public administration would halt the progress of this project, which is so necessary in our society.
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