Corvus Pharmaceuticals has initiated a Phase III clinical trial of its investigational, potent humanised monoclonal antibody, CPI-006, for treating hospitalised patients with Covid-19.
Designed to bind to and activate B cells, CPI-006 can potentially offer a unique immunotherapy approach for treating infectious diseases, including Covid-19.
The study plans to enrol around 1,000 participants at sites in North America, Europe, South Africa and Latin America.
Designed with US Food and Drug Administration’s (FDA) guidance, the double-blind study will analyse the efficacy and safety of CPI-006 versus placebo in hospitalised patients with mild-to-moderate Covid-19.
Participants will randomly receive a single intravenous CPI-006 dose of either 2mg/kg or 1mg/kg or placebo, along with standard of care treatments for Covid-19.
The proportion of patients progressing to respiratory failure or death during the 28 days after dosing will form the trial’s primary endpoint.
Respiratory failure is defined as requiring non-invasive or invasive mechanical ventilation.
Time to recovery, time to resolution of Covid-19 symptoms, and anti-viral antibody responses are some of the secondary endpoints.
On completing 28-day post-treatment visit of 60% of subjects, an independent data monitoring committee will carry out an interim futility and efficacy analysis.
Corvus anticipates results from the study to be available in the fourth quarter of this year.
Corvus Pharmaceuticals president and CEO Richard Miller said: “The devastating nature of the pandemic and emerging understanding of this disease compels us to rapidly develop CPI-006 for the treatment of Covid-19.
“We believe CPI-006’s novel mechanism of action, supported by Phase I results obtained to date, indicate that this agent may be well suited to combat this virus, which is now demonstrating a propensity to mutate, become more transmissible and potentially escape from current vaccination and therapeutic approaches such as the administration of passive anti-viral monoclonal antibodies.”
Last October, Corvus reported positive findings from an ongoing Phase I clinical trial of its immunotherapy candidate, CPI-006, in patients suffering from Covid-19.