Immunic’s IMU-838 Receives the US FDA’s IND Approval to Initiate P-III ENSURE & P-II CALLIPER Studies for RRMS & PMS

July 6, 2021 Auto Bot Clinical Trials, regulatory 0

Shots:

  • The P-III ENSURE (1 &2) program evaluates IMU-838 (30mg, qd) vs PBO in ~ 1,050 patients with active RMS. The 1EPs of both trials is time to 1st relapse @72wks. & 2EPs include a volume of T2-lesions, time to confirm disability progression, changes in cognition & measure brain volume
  • The P-II CALLIPER trial assess IMU-838 (45mg) vs PBO in ~450 patients with PMS. The 1EPs of a trial is a change is an annualized rate of percent brain volume change up to 120wks. & 2EPs include a change in whole-brain atrophy & disability progression
  • The company expects to initiate ENSURE & CALLIPER trial in H2’21 while dosing of 1st patient in CALLIPER trial is expected in Q3’21 & ENSURE trials in H2’21

Click here to­ read full press release/ article | Ref: Immunic | Image: Immunic

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