OncoImmune announced that its investigational immunomodulator SACCOVID (CD24Fc) has demonstrated significant therapeutic efficacy in the phase III SAC-COVID clinical trial.
The trial’s top-line data from 203 participants demonstrate that severe or critical Covid-19 patients treated with SACCOVID witnessed speedy recovery and a significant reduction in disease progression to death or respiratory failure compared to patients securing placebo when used in combination with the standard of care (SOC).
With a planned enrolment of 270 patients, the SAC-COVID phase III clinical trial is randomised, placebo-controlled and blinded to participants, the clinical teams, the investigators, and the sponsor.
OncoImmune has randomised hospitalised Covid-19 patients in two arms, who needed oxygen support, including those requiring supplemental oxygen, high flow oxygen, and non-invasive ventilation. The patients secured either SOC plus a single dose of SACCOVID or SOC plus placebo.
According to the company, the pre-specified interim efficacy and safety analyses have been conducted when 146 patients achieved clinical recovery from Covid-19.
The trial, which was commenced in April this year, was carried out in 15 medical centres in the US.
Multiple participants also secured remdesivir or corticosteroids including dexamethasone, as the trial did not exclude other experimental therapeutics.
SACCOVID, designed to target the innate immune system, has been evaluated for safety in healthy volunteers and phase II clinical trials to prevent graft versus host disease (GVHD) following hematopoietic stem cell transplantation in leukaemia patients, where it also demonstrated therapeutic efficacy.
The National Cancer Institute has partially funded the phase III SAC-COVID clinical trial.
OncoImmune co-founder and CEO Dr Yang Liu said: “The very large therapeutic effect of SACCOVID observed potentially represents a major breakthrough in Covid-19 therapy.
“We took a novel approach to fortify an innate immune checkpoint we discovered, having previously demonstrated efficacy in a nonhuman primate model for treating viral pneumonia, and applied this to SARS-CoV-2.”
In April this year, OncoImmune received a study-may-proceed letter from the FDA for its phase III clinical trial testing the safety and efficacy of CD24Fc for the treatment of hospitalised Covid-19 patients.