News

SSc associated with worse outcomes in hospitalized COVID-19 patients

Hospitalized patients with COVID-19 are more likely to have worse outcomes if they also have systemic sclerosis (SSc), a study finds. This risk was assessed by a composite score that combined several clinical measures, including in-hospital mortality, invasive mechanical ventilation to help with breathing, use of medications to raise…

FT011 showed promising effects on disability, lung function in trial

Treatment with FT011 led to clinically meaningful improvements in physical disability and lung function for some scleroderma patients given the experimental therapy in a Phase 2 clinical trial. Christopher Denton, MD, a professor at University College London, shared the results at the American College of Rheumatology (ACR) Convergence 2023…

1st patient dosed in Phase 2 trial of efzofitimod for SSc-ILD

Dosing has begun in a Phase 2 clinical trial evaluating aTyr Pharma’s efzofitimod, a first-in-class therapy for people with interstitial lung disease (ILD) associated with systemic sclerosis (SSc) — together known as SSc-ILD. Recruitment for the proof-of-concept EFZO-CONNECT study (NCT05892614), which aims to enroll up to 25…

FT011 granted orphan drug designation from FDA

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to FT011, an experimental oral medication that Certa Therapeutics is developing as a treatment for systemic sclerosis. The FDA gives this designation to investigational treatments for rare diseases, those affecting fewer than 200,000 people…

FDA clears Phase 1/2 trial of CAR T-cell therapy for dcSSC

Kyverna Therapeutics is launching a Phase 1/2 trial to evaluate its investigational cell therapy KYV-101 in adults with diffuse cutaneous systemic sclerosis (dcSSc). The move follows the therapy’s recent clearance of an investigational new drug (IND) application by the U.S. Food and Drug Administration (FDA). The trial, called…