ROCKVILLE, Md.--(BUSINESS WIRE)--OncoImmune Inc. today announced that it has closed enrollment of the Phase III SAC-COVID clinical trial (NCT04317040) and releases topline results from the pre-planned interim efficacy analysis. Data from 203 participants (75% of the planned enrollment) show that severe or critical COVID-19 patients treated with SACCOVIDTM exhibited significantly faster recovery and significantly reduced disease progression to death or respiratory failure than those receiving placebo, when used in conjunction with the standard of care (SOC).
The SAC-COVID Phase III clinical trial is randomized, placebo-controlled and blinded to participants, the clinical teams, the investigators, and the Sponsor. Hospitalized COVID-19 patients who required oxygen support, including those requiring supplemental oxygen, high flow oxygen, and non-invasive ventilation were randomly assigned into two arms receiving either SOC plus a single dose of SACCOVIDTM or SOC plus placebo. The trial had a planned enrollment of 270 patients. The pre-specified interim efficacy and safety analyses were performed when 146 patients achieved clinical recovery from COVID-19, a milestone achieved with 203 enrollments. The trial was opened in April this year and was activated in 15 medical centers in the US.
“The interim analysis shows safety and outstanding therapeutic efficacy of SACCOVIDTM. The results indicate that patients who received SACCOVIDTM had a 60% better chance to achieve clinical recovery than those who received placebo (P=0.005). The median time to recovery was 6 days for patients treated with SACCOVIDTM compared with 10 days in the placebo group. In addition, the risk of death or respiratory failure is reduced by more than 50%,” said Dr. Pan Zheng, MD, PhD, Chief Medical Officer and co-founder of OncoImmune. Since the trial did not exclude other experimental therapeutics, many participants also received Remdesivir and/or corticosteroids including dexamethasone. Among them, those who were treated with SACCOVIDTM and Remdesivir recovered 7 days earlier than those who received Remdesivir and placebo (median time to recovery 6 days vs 13 days). Those who were treated with SACCOVIDTM and corticosteroids recovered 10 days earlier than those who received corticosteroids and placebo (median time to recovery 5 days vs 15 days). More detailed information about the trial results will be released as soon as the study is submitted to peer-reviewed medical journals.
“The very large therapeutic effect of SACCOVIDTM 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. We are exhilarated that this approach appears to have led to unparalleled efficacy. OncoImmune is focusing on expanding drug supply and regulatory approval to make the drug available to COVID-19 patients,” said Yang Liu, PhD, Co-founder and Chief Executive Officer.
SACCOVIDTM (known as CD24Fc during its development by OncoImmune, Inc.), is an investigational immunomodulator targeting the innate immune system. CD24Fc has been studied for safety in healthy volunteers and in Phase II clinical trials for the prevention of graft versus host disease (GVHD) following hematopoietic stem cell transplantation in leukemia patients, where it also showed therapeutic efficacy. The Phase III SAC-COVID clinical trial is partially funded through a grant from the National Cancer Institute.
About OncoImmune, Inc.
OncoImmune (www.oncoimmune.com) is a privately-held, clinical-stage biopharmaceutical company focusing on the discovery and development of novel immunotherapies for cancer, inflammation and autoimmune diseases. OncoImmune is based in Rockville, Maryland.
OncoImmune’s lead program, CD24Fc, develops novel therapeutic products based on CD24Fc that regulates host inflammatory response to tissue injuries and may have broadly applicable to cancer, autoimmune disease, metabolic syndrome and graft-versus-host disease (GVHD). OncoImmune has completed a Phase IIa trial using CD24Fc to treat leukemia patients undergoing hematopoietic stem cell transplantation (HSCT). The data from the trial suggest a significant improvement in 180 Day Grade III-IV acute GVHD-Free Survival, the primary endpoint for the Phase III clinical trial called CATHY. CD24Fc prophylaxis also resulted in reduced Relapse and demonstrated improvement in Overall Survival, Non-Relapse Mortality and Relapse-Free Survival, as compared with the controls. A dose-dependent reduction in severe (Grade > 3) mucositis was also observed. A 20 patients open label dose expansion cohort at the recommended clinical dose has been fully enrolled and the CD24Fc continues to perform very well. The Phase III study for the prevention of aGVHD is being initiated nationwide. The CD24Fc programs have been partially funded by the National Institutes of Health and the Food and Drug Administrations.