Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
- decodeMR Team
- Jun 24
- 2 min read
22/06/2026
Merck’s tulisokibart met primary and key secondary endpoints in a Phase 3 study in patiets with moderately to severely active UC (Ref)
Merck announced positive topline results from the Phase 3, ATLAS-UC/NCT06052059 induction only study (Study 2) evaluating tulisokibart (MK-7240; anti-TL1A), in patients with moderately to severely active Ulcerative colitis (UC).
The study met its primary endpoint of clinical remission according to the Modified Mayo Score (MMS) at week 12, as well as key secondary endpoints.
Safety was consistent with previously reported Phase 2 studies and no safety concerns were identified.
Results from the ATLAS-UC Study 2 would be presented with the results from the ongoing induction and maintenance study (Study 1) at an upcoming scientific congress and will be shared with regulatory authorities.
FDA and EMA accepted cemdisiran regulatory submissions for review for the treatment of gMG. (Ref)
Regeneron Pharmaceuticals announced that both the US FDA and EMA had accepted the regulatory applications for cemdisiran to treat adult patients with generalized myasthenia gravis (gMG) who were anti-acetylcholine receptor (AChR) antibody-positive.
The submissions were supported by data from the Phase 3, NIMBLE trial evaluating cemdisiran, in adults with symptomatic gMG who could receive standard of care immunosuppressants based on the investigator’s discretion.
The FDA would review the NDA under Priority Review with a target action date in November 2026.
A decision from the European Commission was anticipated in the second half of 2027.
Prolium Biosciences announced milestones in systemic sclerosis and refractory lupus nephritis (Ref)
Prolium Bioscience announced two milestones for PRO-203 (CD20xCD3 T-cell engager) in patients with systemic sclerosis (SSc) and refractory lupus nephritis.
First patient was dosed in the Phase 1/2/ NCT07641634 SSc study, Part 1 healthy volunteer SAD study completed and informed dosing for Part 2.
Part 2 would enroll up to 24 SSc patients across multiple dose cohorts to assess safety and preliminary efficacy, with a total study duration of up to 53 weeks per participant.
Last patient completed the investigator-sponsored lupus nephritis study/ NCT07104344 and all five treatment-refractory patients completed ≥26 weeks of follow-up.
Data from both the lupus nephritis study and healthy-volunteer SAD study would be presented at an upcoming medical meeting.
