AEMPS approves Peaches' clinical trial with selective secretomes to treat COVID-19-associated cytokine storm
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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.
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The trial will include 42 patients to assess safety, dose range and different administration patterns.
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There are still 775 million confirmed cases of coronavirus (SARS-CoV-2) in the world, resulting in almost 7 million deaths (Mar 2024 source World Health Organization).
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PRS® CK-Storm will be the first in a series of drugs, based on the use of targeted secretomes, to help fight different types of autoimmune diseases.
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The targeted secretome is the set of cytokines and other components that constitute the cellular language established between macrophages and other cell groups for their regeneration or defence against pathogen attacks.
caption: Peaches' CEO announcing approval of the trial
Madrid, 4 October 2024 - During the III Conference of the UAM-Peaches Chair, held yesterday at the Faculty of Medicine of the Autonomous University of Madrid and before numerous representatives of authorities, universities and scientific professionals, Peaches has confirmed the start of its pilot trial, in phase I-II, of PRS® CK STORM, following the authorisation of the Spanish Medicines Agency (AEMPS) and the European Medicines Agency (EMA). A treatment against the cytokine storm of what would be the world's first immunomodulatory drug based on the use of targeted secretomes.
This approval open the way for a revolution in the use of secretome-based therapies and validates Peaches' platform with the capacity to produce up to 20 different complex biologic drugs for highly prevalent pathologies. This research programme aims to prioritise the use of these secretomes 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 for cytokine storm, a very common condition that arises as a response of the immune system to an external pathogen. Cytokine storm occurs in a significant number of cases in people infected with coronavirus, but also in other serious conditions such as pancreatitis or diseases like ulcerative colitis or Crohn's disease.
Juan Carlos de Gregorio, CEO and founder of the company, 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 new therapeutic reality and 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 the secretome trials aimed at muscle repair, treatment of neuropathic pain and tendon regeneration”.
Peaches Biotech's PRS® CK STORM has demonstrated a great capacity as an immunomodulator and anti-inflammatory in animal tests, a preliminary step to start this phase I-II human trial to be conducted at the University Hospital of Fuenlabrada, in which 42 patients will participate.
From cell therapy to secretome therapy
Peaches' therapy is based on having codifed the language with which immune cells communicate with different tissues and having found that each message emitted is different and specific for each tissue. With this discovery, the company reproduces the conditions that occur in our own body, in a cell co-culture medium, to obtain specific secretomes for each type of pathology.
Their main advantages, compared to current cell therapies, are that they have a lower risk of immunological rejection, are much cheaper and have a greater capacity for industrial production, as well as being easier to store and transport, as they can be freeze-dried.
PRS® CK STORM is the first of a new generation of drugs that use the selective secretome to induce this immunomodulatory and anti-inflammatory effect, with the aim of preventing cytokine storm entry. Today, infectious diseases are one of the leading causes of mortality worldwide. The health sector is constantly researching to produce drugs that can alleviate the effects of these diseases.
In the words of Dr. Lapuente, Scientific Director of Peaches Biotech: “This clinical trial allows us to advance in the research of our therapies, based on the use of selective secretomes, to treat pathologies such as the cytokine storm that generates devastating effects in people's bodies. Importantly, in addition to coronavirus, cytokine storm occurs in other important pathologies such as pancreatitis or intestinal infections. PRS® CK STORM aims to identify such adverse responses and prevent them”.
This is the first biological medicine of a large group of drugs that will help to improve people's health and quality of life, demonstrating the potential health benefits of these medicines.