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The first two patients have been treated with opaganib at a leading hospital in Israel. At the time of treatment initiation, both patients suffered from moderate to severe acute respiratory symptoms related to SARS-CoV-2 infection, required supplemental oxygenation and were hypoxic despite being treated with maximum flow of oxygen with cannulas.
Preliminary findings from both patients demonstrated clinical improvement within days post treatment-initiation with opaganib. To date, both patients have shown decreased supplemental oxygen requirements and decreased C-reactive protein (CRP) levels, an important inflammatory biomarker correlated with lung lesions which could reflect disease severity2. Both patients have also shown an increase in lymphocyte levels, a sign of improvement from virus-induced lymphopenia. One of the patients was being treated in the intensive care unit (ICU), was considered for intubation, and was released from the ICU within days of treatment initiation with opaganib.
Opaganib was administered to the hospitalized patients in addition to standard-of-care, which included hydroxychloroquine (HCQ) as background therapy. Opaganib was well tolerated at the doses administered and no opaganib-related treatment emergent adverse events have been reported to date.
In addition, approximately 160 patients are planned to be treated in three major hospitals in northern Italy under an expanded access program approved by the Italian National Institute for Infectious Diseases, allowing compassionate use of opaganib, for patients with confirmed SARS-CoV-2 infection with life-threatening manifestations.
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Preliminary findings from both patients demonstrated clinical improvement within days post treatment-initiation with opaganib. To date, both patients have shown decreased supplemental oxygen requirements and decreased C-reactive protein (CRP) levels, an important inflammatory biomarker correlated with lung lesions which could reflect disease severity2. Both patients have also shown an increase in lymphocyte levels, a sign of improvement from virus-induced lymphopenia. One of the patients was being treated in the intensive care unit (ICU), was considered for intubation, and was released from the ICU within days of treatment initiation with opaganib.
Opaganib was administered to the hospitalized patients in addition to standard-of-care, which included hydroxychloroquine (HCQ) as background therapy. Opaganib was well tolerated at the doses administered and no opaganib-related treatment emergent adverse events have been reported to date.
In addition, approximately 160 patients are planned to be treated in three major hospitals in northern Italy under an expanded access program approved by the Italian National Institute for Infectious Diseases, allowing compassionate use of opaganib, for patients with confirmed SARS-CoV-2 infection with life-threatening manifestations.
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