Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
08/09/2026
Vor Bio announced the completion of enrollment in its Phase 3 trial of telitacept in gMG. (Ref)
Vor Bio announced the completion of enrollment in the Phase3, UPSTREAM MG registrational trial evaluating telitacicept for the treatment of generalized myasthenia gravis (gMG).
Vor Bio expected topline results from the 24-Week primary endpoint in the H1 2027.
Vor Bio also planned to initiate the Phase 3, UPSTREAM oMG, registrational trial evaluating telitacicept for the treatment of patients with ocular myasthenia gravis, with the first patient dosing anticipated in the H1 2027.
Spyre Therapeutics announced Phase 2 Part A induction results for SPY003 in UC. (Ref)
Spyre Therapeutics announced positive Week 12 induction data from the Part A of the Phase 2, SKYLINE trail of SPY003 (anti-IL-23) for the treatment of moderately-to-severely active ulcerative colitis (UC).
SPY003 met its primary endpoint with a statistically significant reduction of 10.0 points (p<0.0001) from baseline at Week 12 in Robart’s Histopathology Index (RHI) score.
Secondary endpoints, 20% of patients achieved clinical remission by modified Mayo Score and 30% achieved endoscopic improvement at week 12.
SPY003 was well tolerated with a safety profile consistent with the IL-23 class.
Alebund Pharmaceuticals announced FDA clearance of its IND application for AP308 for the treatment of IgA Nephropathy. (Ref)
Alebund Pharmaceuticals announced that it had recently received clearance from the US FDA for its Investigational New Drug (IND) application for AP308 (an engineered recombinant IgA protease) for the treatment of IgA nephropathy.
Alebund planned to initiate the clinical trial in the near term.
The IND clearance marked the transition of AP308 from preclinical research into clinical development.
Greywolf Therapeutics dosed the first participant with axSpA in the Ph1/2 trial of GRWD0715. (Ref)
Greywolf Therapeutics announced that the first participant with axial spondyloarthritis (axSpA) had been dosed in the multiple ascending dose (MAD) portion of the Phase 1/2, EAST-1/ NCT07047703 study evaluating GRWD0715 (oral ERAP1 inhibitor).
The ongoing MAD portion in participants with axSpA was expected to generate PK/PD, translational biomarker and preliminary clinical endpoint data to inform dose selection for the placebo-controlled Phase 2a proof-of-concept portion of the study.
The company planned to start the Phase 2a portion in H2 2027.
