Covid-19 is a respiratory illness ranging from mild to severe. Elderly patients or patients with risk factors are more vulnerable to develop the severe and potentially deadly form of the disease.
A so-called “cytokine storm” and hyper-inflammation syndrome, caused by the excessive production of multiple inflammatory substances and cytokines, can be observed in the most severely ill participants.
This leads to acute respiratory distress syndrome (ARDS), characterized by the acute onset of hypoxemic respiratory failure (lack of oxygen), causing patients to struggle to breathe and therefore require intensive care unit admission and oxygen therapy.
The excessive production of these inflammatory substance and cytokines needs to be hindered to avoid the occurrence of ARDS and thus reduce the severity of this disease.
The study medication has three characteristics with a desirable and complementary triple effect to treat Covid-19 participants:
1) Antiviral effect to inhibit viral replication of SARS-CoV-2, the virus that causes Covid-19;
2) Anti-inflammatory effect to prevent and treat the ARDS that requires intensive care and oxygen therapy;
3) Tissue repair properties preventing longer-term pulmonary problems after Covid-19 disease.
The medication is currently being studied for the treatment of chronic inflammatory diseases and has also been studied in participants with HIV. During these studies, the study medication showed three positive effects which are desirable to effectively treat participants with Covid-19 disease:
The study medication showed the capacity to reduce or eliminate the viral HIV reservoirs in two studies.
The antiviral effect has now also been shown in laboratory tests and demonstrated the ability to inhibit the multiplication of SARS-CoV-2 virus (Covid-19), with a magnitude of effect similar to Remdesivir, the only drug currently approved in some countries for emergency use against Covid-19.
The study medication could thus potentially achieve a reduction in the viral load (number of viruses) of Covid-19. You can find more information (in English) in our press release.
ABX464 has demonstrated impressive efficacy in a study in ulcerative colitis, a severe inflammatory bowel disease, and the way it works biologically supports the rationale to treat hyper-inflammation observed in relation with Covid-19, which can lead to hospitalization.
A so-called "cytokine storm" and hyper-inflammation are the primary cause of the respiratory distress and death following Covid-19 infection.
Specific to healthcare professionals: the study medication has been shown to specifically upregulate a microRNA, miR-124, a “physiological brake” of inflammation. miR-124 down-regulates the multiple inflammatory substances and cytokines that are involved in the Covid-19 cytokine storm, including TNF alpha, IL-1 beta, G-CSF, IL-6, MCP-1 and IL-17.
You can find more information about the Phase 2a results in ulcerative colitis on our website and in the press release issued following the publication of the results (available only in English).
The study medication has shown its ability to heal inflammatory lesions in ulcerative colitis participants.
This means that participants with Covid-19 may benefit from the anti-inflammatory effect of the study medication as well as its tissue repair properties, to prevent potential longer-term pulmonary dysfunction following the infection.
To date, over 300 participants have been treated with this study medication, including those who have been on continuous daily dosing for up to two years. Based on our observations, ABX464 shows a very good clinical safety and tolerability profile.