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OncoImmune has announced plans to continue enrolment for the Phase III clinical trial of CD24Fc for the treatment of severe and critical Covid-19 patients.
The decision comes after the Institutional Review Board’s approval following a review of the safety data.
OncoImmune is conducting the Phase III trial to assess the safety and clinical efficacy of CD24Fc in the patient population. The first 70 participants have been randomised to receive either CD24Fc or placebo.
OncoImmune chief medical officer Dr Pan Zheng said: “We have seen neither infusion reactions nor other drug-related adverse events associated with the trial in first 70 patients.
“The mortality rate so far is 5%, which is considered low among severe and critical Covid-19 patients. The preliminary results show that the safety of the drug is outstanding for this indication.”
CD24Fc is a biologic designed to protect an innate immune checkpoint against excessive inflammation due to tissue-injuries.
The Phase III trial of the drug candidate is enrolling severe and critical Covid-19 patients needing supplemental oxygen support or high flow oxygen non-invasive ventilation at ten medical centres across the US.
Participants are administered with a single infusion of CD24Fc or placebo at the start of the study and are followed for up for 28 days to establish the time to clinical improvement.
A total of 230 patients will be enrolled into the trial, which will assess time to clinical improvement from severe or critical to mild symptoms as the primary outcome.
The US Food and Drug Administration (FDA) granted approval for OncoImmune to conduct the Phase III trial of CD24Fc in April this year.