Logo

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

Share this

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

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

  | Ref: Immunic | Image: Immunic

Click here to­ read the full press release 

Senior Editor

This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com

Share this article on WhatsApp, LinkedIn and Twitter

Join the PharmaShots family of 12000+ subscribers

I accept the Terms and Conditions