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RedHill Biopharma has reported preliminary data from a compassionate use programme of opaganib (Yeliva, ABC294640) to treat Covid-19 patients in Israel.
The results are from two patients who had moderate to severe Covid-19-related acute respiratory symptoms.
These patients needed supplemental oxygenation and experienced hypoxia even after treatment with maximum oxygen flow using cannulas.
The patients were given opaganib plus standard-of-care, including hydroxychloroquine (HCQ) as background therapy.
Opaganib is an investigational sphingosine kinase-2 (SK2) selective inhibitor said to possess anticancer, anti-viral and anti-inflammatory properties.
According to the data, both patients showed clinical improvement within days after treatment-initiation with opaganib.
So far, the patients also required lower supplemental oxygen and demonstrated reduced C-reactive protein (CRP) levels, which is an inflammatory biomarker linked to lung lesions that may indicate disease severity.
In addition, both patients have shown a rise in lymphocyte levels, which is considered as a sign of improvement from virus-related lymphopenia.
Data also revealed that RedHill’s drug was well tolerated at the administered doses without any associated treatment emergent adverse events to date.
RedHill Biopharma medical director Mark Levitt said: “We are very encouraged by the preliminary findings showing clinical improvement in the first Covid-19 patients treated with opaganib, which further supports its safety and potential benefit to patients.
“Our hope is that the unique mechanism of action of opaganib, with both anti-viral and anti-inflammatory activity, will help Covid-19 patients by reducing lung inflammation, and thus preventing the disease from progressing to a stage which requires mechanical ventilation.”
The company is looking to expand the compassionate use of the drug in Covid-19 indication to other hospitals and countries.
As part of a Italian National Institute for Infectious Diseases-approved expanded access programme, nearly 160 patients are set to receive the drug at three hospitals in northern Italy.
The company is also in discussions in the US and additional countries to boost the access to opaganib under compassionate use authorisations and emergency clinical development programmes.