AEMPS approves Peaches clinical trial with selective secretomes to treat COVID-19-associated cytokine storm
Peaches starts its phase I-II pilot trial to obtain an advanced biologic drug that will help combat cytokine storm, a very common reaction in patients with COVID-19, but also in other pathologies such as pancreatitis.
Peaches confirms the start of its Phase I-II pilot trial of PRS® CK STORM, following authorisation by the AEMPS and the EMA. A treatment against cytokine storm of what would be the world's first immunomodulatory drug based on the use of selective secretomes.
This approval breaks new ground in the use of secretome-based therapies and validates Peaches' platform with the capacity to produce up to 20 different complex biologics for highly prevalent pathologies. This research programme aims to prioritise the use of the selective secretome for the regeneration of different tissues, including bone, tendons, muscles and the immune system.
The support of both agencies lays the foundation for an effective treatment against the cytokine storm that occurs in a significant number of cases of people infected with coronavirus, but also in other serious conditions such as pancreatitis or diseases such as ulcerative colitis or Crohn's disease.
Juan Carlos de Gregorio, CEO of Peaches, says: “The authorisation from the AEMPS validates our platform ready to offer a group of biological medicines that we hope will be part of the Spanish and European healthcare system in the near future. It will be a solution to the problems of cell therapies that prevent their accessibility to a large number of patients due to price or logistical problems. This trial will be followed by secretome trials aimed at muscle repair, treatment of neuropathic pain and tendon regeneration”.
This phase I-II human trial will be conducted at the University Hospital of Fuenlabrada and will involve 42 patients.