Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
- decodeMR Team
- May 19
- 3 min read
Updated: May 21
19/05/2026
UCB announced week 16 data from the BE BOLD study in PsA (Ref)
UCB announced data from the Phase 3, BE BOLD/ NCT06624228 study which compared the efficacy of BIMZELX®(bimekizumab; Anti-IL-17A and anti-IL-17F) versus SKYRIZI®(risankizumab; Anti-IL-23) after 16 weeks of treatment in participants with active psoriatic arthritis (PsA).
The study met its primary endpoint of belimumab superiority in ACR50 at Week 16, which was achieved by 49.1% receiving bimekizumab vs 38.4% of those receiving risankizumab, with statistical significance (p=0.0078).
Numerically greater responses without statistical significance were observed for bimekizumab vs risankizumab across all secondary endpoints.
The secondary endpoint of ACR50 at Week 4 was achieved in 19.9% of those receiving bimekizumab vs 7.2% of those receiving risankizumab.
53.4% of those receiving bimekizumab and 46.6% receiving risankizumab achieved the PASI100 exploratory endpoint at Week 16.
No new safety signals were identified, and overall safety profiles were comparable between treatments, except for Candida infections which were more frequent for bimekizumab.
Zenas BioPharma announced the upcoming presentation of results from the Phase 3 trial of Obexelimab in IgG4-RD at EULAR 2026 Congress (Ref)
Zenas BioPharma announced that the data from the Phase 3, INDIGO trial, which evaluated obexelimab in Immunoglobulin G4-Related Disease (IgG4-RD) would be presented in an oral presentation at the upcoming European Alliance of Associations for Rheumatology (EULAR) 2026 Congress.
The study met its primary endpoint, demonstrating a highly statistically significant and clinically meaningful 56% reduction in the risk of IgG4-RD flare compared to placebo (p=0.0005) at 52-week.
Obexelimab also met and demonstrated highly statistically significant activity compared to placebo on all four key secondary endpoints:
Time to first investigator-determined flare requiring rescue therapy (p=0.0001).
Number of investigator and AC-determined flares requiring rescue therapy (p=0.0008).
Proportion of patients achieving complete remission (p=0.0049).
Cumulative glucocorticoid rescue therapy use (p=0.0042).
Obexelimab was well tolerated, with no new safety signals observed.
Savara presented long-term data from the Phase 3 OLE study of molgramostim inhalation solution in aPAP (Ref)
Savara presented a poster at the ATS 2026 International Conference. The poster reported long-term efficacy and safety data from the first 48 weeks of the ongoing Phase 3, IMPALA-2, open-label extension (OLE) treatment period which evaluated molgramostim inhalation solution (molgramostim) for the treatment of Autoimmune Pulmonary Alveolar Proteinosis (aPAP).
The 48 weeks, OL treatment period showed continuous and sustained improvements in pulmonary gas transfer, as measured by DLco% and in respiratory HRQoL, as measured by SGRQ-T and SGRQ-A scores.
Data from the OL treatment period indicated that molgramostim was generally well tolerated, with safety and tolerability results consistent with those previously reported for the double blind treatment period.
Tiziana announced positive data for intranasal foralumab in non-active secondary progressive multiple sclerosis (Ref)
Tiziana Life Sciences announced updated data from its ongoing expanded access program which evaluated intranasal foralumab (anti-CD3 mAb) in patients with non-active Secondary Progressive Multiple Sclerosis (na-SPMS).
The data demonstrated that intranasal foralumab continued to be well tolerated over extended treatment durations.
Patients showed favorable trends in stabilization of disability as measured by the Expanded Disability Status Scale (EDSS) and meaningful improvements in fatigue as measured by the Modified Fatigue Impact Scale (MFIS).
ImmuneOnco announced first patient dosed in Phase 2 trial of mourofavfop alfa for SLE (Ref)
ImmuneOnco Biopharmaceuticals announced that the first patient had been successfully enrolled and dosed in a Phase 2 trial which evaluated amourofavfop alfa (IMM0306; CD47xCD20) for the treatment of active systemic lupus erythematosus (SLE).
This was a Phase 2 randomized controlled study planned to enroll 90 patients, who would be randomly assigned in a 1:1:1 ratio to three treatment arms receiving either 1.2 mg/kg or 1.6 mg/kg of IMM0306, or a placebo.
Clinical development of a subcutaneous formulation of IMM0306 was also underway.
