Author Archives: Steve Bryson PhD

No safety concerns seen one month after dosing with KYV-101 for lupus

No signs of neurotoxicity were seen for 28 days after the first patient in a Phase 1 clinical trial was dosed with KYV-101, Kyverna Therapeutics’ investigational cell therapy for lupus nephritis, a lupus complication marked by kidney damage. A standard 4-week post-infusion observation period in such clinical trials is…

Kyverna, Verily team up to identify KYV-101 response biomarkers

Kyverna Therapeutics will use Verily Life Sciences’ high-resolution Immune Profiler to identify biomarkers to measure responses to KYV-101, Kyverna’s experimental cell therapy for lupus-related kidney disease. KYV-101 is being evaluated in an open-label trial, which is recruiting nine to 12 patients at clinical sites across the U.S.

For Black women with SLE, racial discrimination tied to inflammation

Racial discrimination was found to be associated with increased inflammation among Black women with systemic lupus erythematosus (SLE) in a recent study. Each experience of racial discrimination was tied to a nearly 4% increase in the levels of C-reactive protein (CRP), an inflammation marker, in the bloodstream, the findings…

Dosing begins in Phase 2b trial for SLE therapy ESK-001

A Phase 2b clinical trial of ESK-001, an oral treatment for systemic lupus erythematosus (SLE), has begun dosing patients, according to its developer Alumis. The trial, called LUMUS, is expected to enroll about 388 adults with moderately to severely active SLE who test positive for self-reactive antibodies (autoantibodies).

Lupus awareness campaign aims to reach Latinas and Black women

The Lupus Foundation of America (LFA) has launched a new awareness campaign to help Black/African American and Hispanic/Latina women recognize the signs and symptoms of lupus. Dubbed “Be Fierce. Take Control,” the digital awareness campaign especially aims to reach young, undiagnosed women among this population, among whom…

1st patient enrolled in global Phase 2 trial of daxdilimab for lupus

A Phase 2 trial evaluating the safety and efficacy of daxdilimab, a potentially first-in-class treatment for people with active, proliferative lupus nephritis (LN) — a lupus complication marked by kidney damage — has enrolled its first patient. Horizon Therapeutics, the therapy’s developer, anticipates about 210 patients, ages 18–80,…

Long-term safety of Lupkynis for SLE confirmed in AURORA trial

Over 18 months, the approved therapy Lupkynis (voclosporin) lessened inflammation and prevented further kidney damage in systemic lupus erythematosus (SLE) patients with active lupus nephritis, without any signs of kidney-related toxicity seen with similar treatments. New top-line data show participants in the Lupkynis treatment arm of the now…

Phase 2 Trial Tests Daxdilimab as Potential DLE Therapy

The first patient has been enrolled in RECAST DLE, a Phase 2 study evaluating daxdilimab, a potentially first-in-class therapy for moderate-to-severe discoid lupus erythematosus (DLE), a form of lupus that affects the skin. Horizon Therapeutics, the therapy’s developer, expects to enroll about 100 DLE patients, ages 18–75 whose…