Mgmt Lunch Reinforces Conviction In Telitacicept For MG And SjD

研报英文原文证据摘录

Mgmt Lunch Reinforces Conviction In Telitacicept For MG And SjD

TD Cowen Vor Bio

Global Research May 26, 2026

This distinction is critical as systemic disease provides a clearer signal in clinical

trials. Unlike symptom-driven endpoints (ESSPRI), which have limited dynamic range

and high variability, systemic disease activity (ESSDAI) offers a more objective and

scalable endpoint for demonstrating therapeutic benefit. Management reiterated

that historical failures in Sjogren’s (e.g., Orencia, Benlysta) were largely attributable

to variability in outcome measures rather than absence of biological activity.

Sjogren's Ph3 UPSTREAM-SjD Trial Optimized To Mitigate Placebo Effect By

Limiting ESSDAI Variability And Implementing Steroid Taper

The global Ph3 UPSTREAM SjD (n=~250) study is explicitly designed to address these

historical challenges. The trial enrolls a homogeneous population defined by ESSDAI

≥5 and SSA/Ro positivity, with patients randomized 1:1 and is 80% powered to detect

a clinically meaningful improvement of ~2 ESSDAI points at Week 48.

Vor will implement 3 strategies to minimize variability of the ESSDAI scoring system:

(1) central adjudication of ESSDAI scoring, (2) inclusion of experienced investigators

from prior global trials for NVS' ianalumab and JNJ's nipocalimab, and (3) strict

source verification for any score changes are intended to reduce placebo variability

and regression-to-the-mean effects.

An additional differentiator is the inclusion of a steroid taper over the first 3 months,

which is designed not to drive flares but to eliminate “false responses”. This is driven

by chronic steroid use and thereby sharpen separation between active and placebo

arms. Patients are required to be on 10mg/day or less at the start of the study, and