Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
- decodeMR Team
- 8 hours ago
- 2 min read
13/07/2026
Novartis received Health Canada approval for VANRAFIA™ to reduce proteinuria in adults with primary IgAN (Ref)
Novartis Pharmaceuticals Canada announced that Health Canada had granted approval for VANRAFIATM (atrasentan tablets; ETA receptor antagonist) for proteinuria reduction in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally defined as UPCR ≥ 1.5 g/g.
The Health Canada authorization was based on Phase 3, ALIGN study in adults with biopsy-proven primary IgAN, eGFR ≥ 30 mL/min/1.73 m2 and total urine protein ≥ 1 g/day who were on a stable dose of maximally tolerated renin-angiotensin system inhibitor therapy.
In the Phase 3 study, VANRAFIATM demonstrated a statistically significant reduction in 24-hour UPCR at Week 36 compared with placebo.
IQIRVO® demonstrated statistically significant improvement in ALP normalization in patients with PBC in Phase 3b study (Ref)
Ipsen announced the results from the Phase 3b, ELSPIRE/ NCT06383403 study of IQIRVO® (elafibranor; PPAR agonist) in patients with Primary Biliary Cholangitis (PBC).
The Phase 3b trial met its primary endpoint with statistical significance:
ALP normalization was achieved in 85% of patients treated with elafibranor vs 23% on placebo (p= <0.0001) at Week 52.
The safety profile of IQIRVO was consistent with the known profile and no new safety signals were identified.
Ipsen planned to present these data at an upcoming medical meeting and submit to regulatory authorities.
Q32 Bio announced results from Part B of the Phase 2a study of bempikibart in Alopecia Areata (Ref)
Q32 Bio announced positive topline results from Part B of the Phase 2a, SIGNAL-AA trial evaluating bempikibart (anti-IL-7Rα antibody) in patients with severe or very severe Alopecia Areata (AA).
Clinically meaningful efficacy on the primary endpoint were observed with a mean percent reduction in SALT score from baseline of 35.3% in the prespecified mITT analysis.
At week 36, a SALT-20 response was achieved by 40.0% of patients in the mITT analysis and by 30.3% of patients in the ITT analysis of all enrolled patients.
Bempikibart was generally well-tolerated with safety profile, consistent with prior studies, with no new safety signals and with a favorable PK, PD and ADA profile.
These data supported further development of bempikibart in AA and the company intended to advance a registration-directed program in H1 2027.
