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In addition, the FDA also gave a green signal to the company's separate IND application for the supportive Phase 2 CALLIPER trial of IMU-838 in patients with progressive multiple sclerosis (PMS).
The ENSURE program comprises two Phase 3 trials designed to evaluate the efficacy, safety, and tolerability of IMU-838 versus placebo in RRMS patients.
The Phase 2 CALLIPER trial is intended to run concurrently and complement the Phase 3 program in RRMS.
In particular, CALLIPER is focused on progressive forms of multiple sclerosis and designed to corroborate IMU-838's neuroprotective potential, as exemplified by slowing of brain atrophy and delay in disability worsening.
Dosing in the ENSURE trials will start in the second half of 2021.
The CALLIPER trial is expected to enroll approximately 450 patients, and dosing will commence in the third quarter of 2021.
IMUX Price Action: IMUX shares were trading 1.63% higher at $12.46 at last check Thursday.
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