Rigel Pharmaceuticals has reported top-line data from the Phase III FOCUS clinical trial of fostamatinib in Covid-19 patients admitted to the hospital.
The double-blind, multicentre, placebo-controlled trial had 280 such patients, without respiratory failure, but who have some high-risk prognostic factors.
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These subjects were categorised to receive either fostamatinib plus standard of care (SOC) or a placebo plus SOC.
The number of days subjects spent on supplemental oxygen through to day 29 was the trial’s primary endpoint.
Risk of death, improvement of the participant from severe ailment, hospitalisation duration, and number of ICU days and safety were included as the secondary endpoints.
According to the findings, the trial neared but failed to meet statistical significance in the primary efficacy endpoint.
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By GlobalDataIn the fostamatinib treatment group, the mean number of days on oxygen through to day 29 was reported to be 6.9 days versus nine days in subjects who received a placebo.
Four cases of death were observed in the fostamatinib arm versus eight in the placebo arm by day 29.
Fostamatinib also offered a 50% decline in all-cause mortality in patients.
All prespecified secondary endpoints showed to numerically favour fostamatinib compared to a placebo.
In the trial, fostamatinib’s safety profile was in line with previous clinical experience, without any new safety issues reported.
Fostamatinib is an inhibitor of oral spleen tyrosine kinase (SYK).
Rigel Pharmaceuticals president and CEO Raul Rodriguez said: “While the Covid-19 pandemic has abated, we believe that fostamatinib may have an important role in the treatment of patients with Covid-19 based upon these top-line data.
“We are encouraged by the results of our Phase III clinical trial in that regard.”
In April last year, the company reported that the Phase II trial of fostamatinib to treat hospitalised Covid-19 patients met the primary safety endpoint.
