Exhibit 99.1
Equillium Receives FDA Clearance of COVID-19 IND for Phase 3 Trial
Equillium plans to initiate global Phase 3 COVID-19 trial – EQUINOX – during Q4 2020
FDA indicates study could support BLA filing
LA JOLLA, Calif., Oct. 29, 2020 – Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders, today announced that it has received a Study May Proceed letter from the U.S. Food and Drug Administration (FDA) to begin a Phase 3 clinical trial, named EQUINOX, evaluating itolizumab in hospitalized 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 FDA 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).
“Itolizumab’s novel immune-modulating mechanism has the potential to regulate the cytokine cascade that is at the root of multiple complications seen in hospitalized COVID-19 patients, including blood clots, tissue damage and organ failure, as well as ARDS,” said Ivor S. Douglas, M.D., FRCP (UK) Professor of Medicine, Chief of Pulmonary and Critical Care and Medical Director, Medical Intensive Care Denver Health Medical Center and principal investigator for the EQUINOX trial. “As we are confronting surging rates of COVID-19 infections globally, I anticipate a sharp rise in patients with severe disease requiring oxygen support or other life-saving critical care measures. As the principal investigator in the EQUINOX trial, it is my hope that this study will help propel a highly effective new treatment option closer to availability for these vulnerable and high-risk patients.”
The Phase 3 EQUINOX trial will enroll a total of 800 patients at sites in the United States and abroad and include interim assessments at 20% and 50% 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 hospitalized 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.
More details about the EQUINOX trial will be provided at an upcoming Analyst Day that Equillium will be hosting on December 4, 2020.
“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. “The initiation of the EQUINOX Phase 3 trial represents an important milestone for Equillium and for COVID-19 patients worldwide. We look forward to partnering with Dr. Douglas and our global sites to further evaluate itolizumab as a promising treatment for hospitalized COVID-19 patients.”
