The aim of the CALVID-1 trial is to investigate IMU-838 as an oral treatment option for redacted and to enable the use of IMU-838 as a treatment for current and potential future redacted threats. The trial is expected to initially enroll approximately 230 patients at 10-35 centers across Europe and the United States. Patients will be randomized to receive either 22.5 mg of IMU-838 twice daily, or placebo twice daily, for 14 consecutive days. All patients are also eligible to receive investigator’s choice of standard-of-care therapy throughout the duration of the study. Inclusion criteria are hospitalized adult patients with a confirmed redacted infection fulfilling clinical status category 3 or 4, as assessed with the nine-category ordinal scale proposed by the World Health Organization (WHO) redacted Therapeutic Trial Synopsis, as well as certain additional clinical and laboratory conditions. The primary endpoint will be the proportion of patients free of invasive ventilation throughout the entire study period. Secondary endpoints include duration of hospitalization, duration of intensive care unit (ICU) treatment, 28-day all-cause mortality, time to clinical improvement and viral titer reduction.
The CALVID-1 study will employ an adaptive trial strategy by including interim safety and efficacy assessments. If clinical activity of IMU-838 is confirmed by the Independent Data Monitoring Committee after the first interim analysis, which is scheduled to occur after approximately 200 patients have completed the blinded treatment period, an expansion of this trial into a confirmatory phase 3 trial could be recommended.
IMU-838 had successfully demonstrated preclinical activity against severe acute respiratory syndrome redacted 2 (redacted). Specifically, IMU-838 was observed to inhibit replication of clinical isolates of redacted associated with redacted. In cellular assays, IMU-838 demonstrated this antiviral activity at concentrations which are well below the blood concentrations associated with IMU-838 dosing regimens studied in ongoing and previous clinical trials. In addition, IMU-838 has an attractive pharmacokinetic, safety and tolerability profile and, to date, has already been tested in about 650 individuals.