The preliminary results from a preclinical study using a new chemical entity, opaganib, showed a reduction of thrombosis (blood clotting) in animal models with acute respiratory distress syndrome (ARDS), announced the Israel-based biopharmaceutical company, RedHill Biopharma. ARDS-induced thrombosis may happen in up to one-third of COVID-19 patients needing ICU admission and is a major cause of death.
Opaganib is an orally-administered potential COVID-19 treatment combining potent antiviral and anti-inflammatory mechanisms of action. It is a selective inhibitor of sphingosine kinase 2 (SK2), a host cell component, and helps in lowering the chances for resistance arising from viral mutations.
The preclinical study analysed 250mg/kg of opaganib to measure thrombotic risks.
The company in September had already demonstrated opaganib’s potent inhibition activity towards SARS-CoV-2. As per the study, the drug completely inhibited SARS-CoV-2 viral replication as measured after three days incubation in an in vitro model of human bronchial tissue, comparing favourably with remdesivir.
RedHill plans to analyse different physiologically and pharmacologically relevant opaganib doses that can reduce thrombosis.
“Results from our study show opaganib 250mg/kg reduced blood clot length, weight and total thrombus score in a preclinical model of ARDS,” said RedHill R&D senior vice-president Reza Fathi.
This adds to the known antiviral and anti-inflammatory activities of opaganib and provides the potential for a unique triple-action effect on the pathophysiological processes associated with COVID-19 disease.
RedHill is carrying out a phase II study assessing safety and potential efficacy signals of opaganib in patients with severe COVID-19 pneumonia in the US. It has enrolled 40 subjects with the last patient receiving the final dose and the results are expected later this month, said the company.
In addition, a global phase II/III study of opaganib on 270 patients with severe COVID-19 pneumonia has enrolled more than 60% of patients. To date, the study has been approved in Brazil, Israel, the UK, Italy, Russia and Mexico, with plans to expand further ongoing. The top-line data from the study can be expected in the first quarter of 2021, according to the company.