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The Phase 3 trial called as EQUINOX will enroll a total of 800 patients at sites in the United States and abroad and include interim assessments at 20 percent and 50 percent of enrollment.
Biocon's US partner Equillium said it has got USFDA clearance to begin a Phase 3 clinical trials, to evaluate biologic drug itolizumab in hospitalised COVID-19 patients suffering from acute respiratory distress syndrome (ARDS).
Equillium plans to start enrolling patients during the fourth quarter of 2020, and initial clinical data is expected mid-year 2021.
The clinical-state biotech said in a letter the US drug regulator has indicated that the trial, if it meets its primary and key secondary endpoints, may be sufficient to support regulatory filing of a Biologic License Application (BLA).
The Phase 3 trial called as EQUINOX will enroll a total of 800 patients at sites in the United States and abroad and include interim assessments at 20 percent and 50 percent of enrollment.
Patients enrolled in the trial will be randomized 1:1 to receive either itolizumab or placebo in addition to best supportive care for the treatment of COVID-19. Patients will receive up to two doses of study drug (itolizumab or placebo) at Day 1 and Day 8 (if needed) and will be monitored through Day 28 while hospitalised or through post-discharge follow-up.
"The primary endpoint of the trial is to evaluate the benefit of itolizumab on recovery in patients hospitalized with COVID-19; key secondary endpoints include mortality benefit and other measures of clinical improvement. The trial will also evaluate the safety, tolerability and pharmacokinetics (PK) of itolizumab," Equillium said in a statement.
Itolizumab, which is used for the treatment of psoriasis, is repurposed for COVID-19, as it regulates the production of inflammatory cytokines or cytokine storm, seen in serious COVID-19 patients where the immune system attacks the organs, leading to death.
Biocon has out-licensed itolizumab to US-based Equillium in 2017 for development in the US and Canada. Equillium has been awarded ‘fast track’ and ‘orphan drug’ designations for the molecule in both prevention and treatment of graft-versus-host disease (GHVD) by the USFDA.
On July 11, the Drug Controller General of India approved restricted emergency use of itolizumab injection for treating moderate to severe coronavirus disease (COVID-19) cases. The approval has been granted based on a randomised, controlled, open-label study at four hospitals in India, enrolling a total of 30 hospitalised COVID-19 patients with moderate to severe ARDS.
You can read an explainer here about itolizumab trial, and why it raked controversy.
In October 2020, Biocon initiated a 300-patient Phase 4 trial with itolizumab to treat COVID-19 patients in India to generate a larger body of scientific evidence to support the safety, efficacy and usefulness of itolizumab to treat COVID-19 patients.
“While we feel a tremendous sense of urgency in the face of the COVID-19 pandemic, we remain committed to conducting studies with scientific rigor, which is why we are undertaking a robust, double-blind, placebo-controlled study, the gold standard for measuring a drug’s efficacy,” said Bruce Steel, chief executive officer of Equillium.
Equillium and Biocon are working closely together on the further development of itolizumab in COVID-19 patients and, importantly, planning scale-up of manufacturing to support access to treatment for the greatest possible number of patients worldwide.