MedRegen’s lead drug (MRG-001) is a novel fixed-dose drug combination of two existing FDA approved drugs, consisting of plerixafor and tacrolimus.
Tissue injury caused by disease or trauma leads to cell death and organ dysfunction. MRG-001 administration mobilizes stem cells and immunomodulatory cells into the peripheral circulation that are attracted by chemokines secreted by injured organs, known as stromal cell-derived factor 1. Stem cells migrate to the injured tissue and are able to replace injured endothelium by means of angiogenesis and replace dead cells by differentiating into tissue specific cell types. Additionally, immunomodulatory cells such as anti-inflammatory M2-type macrophages and FOXP3+ regulatory T-cells are also recruited to the site of injury to minimize inflammation.
This unique mechanism of action may prove beneficial in treating patients with severe COVID-19 illness and a variety of other diseases. In specific, COVID-19 patients suffer from endothelial cell death and damage by the SARS-CoV-2 virus leading to a loss of alveolar-capillary barrier function and fluid accumulation with reduced gas exchange and pneumonia. Preclinical research with MRG-001 has shown the ability of incoming stem cells to differentiate and replace damaged endothelial cells and mobilize bone marrow derived stem cells to the injured lung.
Separately, due to extensive lung injury, cell death and inflammation COVID-19 patients can develop a cytokine storm. This phenomenon is associated with a worse outcome and higher mortality in COVID-19 patients. The body starts to attack its own cells rather than fighting of the virus because of the state of hyper inflammation. By mobilizing immunomodulatory cells with MRG-001, we expect that cytokine storm is prevented. The COVID-19 ARDS trial is currently the only active trial, however trials for other disease indications are expected to be initiated in the third quarter of 2021.
MedRegen has been very active in exploring MRG-001’s potential in other pre-clinical disease indications as demonstrated here below.
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