Immunic Stock Jumps As FDA Signs Off On 2 Clinical Trial Applications

  • The FDA has signed off Immunic Inc's IMUX investigational new drug application for the Phase 3 ENSURE program of lead asset IMU-838 in patients with relapsing-remitting multiple sclerosis. 
  • 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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