The European Medicines Agency (EMA) has granted orphan drug status to FT011, an oral therapy candidate that Certa Therapeutics is developing for systemic sclerosis (SSc). The U.S. Food and Drug Administration (FDA) awarded the therapy a similar status last year, followed by fast track designation this year.
News
Patients with systemic sclerosis (SSc) who have a stem cell transplant see normalized gene activity related to immune function up to 4.5 years after the procedure. That’s according to recent data from samples in the Phase 2/3 SCOT trial (NCT00114530), wherein the potential benefits of a stem cell…
Ferroptosis, a cell death process that can help to regulate uncontrolled cell growth, was suppressed in skin cells from people with systemic sclerosis (SSc), according to recent research. Such suppression appears to be mediated by increased activity of an antioxidant protein called GPX4. Researchers believe that targeting GPX4 to…
CONQUEST, a platform clinical trial launched by the Scleroderma Research Foundation (SRF), is now enrolling people with interstitial lung disease associated with systemic scleroderma (SSc-ILD) at centers in the U.S. The study is analyzing two investigational therapies using a master protocol to compare both treatments with a…
Treatment with Letairis (ambrisentan) — approved to treat pulmonary arterial hypertension (PAH), a common complication of systemic sclerosis (SSc) — may help prevent the development of PAH, or high blood pressure in the arteries…
The first healthy volunteers have been dosed in a Phase 1 clinical study that’s evaluating MDI-2517, a small molecule candidate to treat scleroderma and interstitial lung disease (ILD), which occurs when the lungs become scarred. According to developers MDI Therapeutics, MDI-2517 is a potent blocker…
Problems with the heart’s left ventricle at a subclinical — not yet symptomatic and overt — level were evident in 1 in every 4 people with systemic sclerosis (SSc) taking part in an Australian study when a potentially more sensitive measure than left ventricle ejection fraction was used. Both…
More than half of people with systemic sclerosis (SSc) who hesitated to get vaccinated against COVID-19 were concerned they might have a flare-up, but very few vaccinated patients have reported their symptoms worsening, according to a 2021–2022 survey study. “Even though the peak of the pandemic has passed, COVID-19…
June is awareness month for scleroderma, and this year’s theme chosen by the National Scleroderma Foundation is “Every Journey Matters,” to recognize the unique ways in which each person in the community experiences the disease. To encourage people to stay engaged in the lead-up to World Scleroderma…
Anti-SSA self-reactive antibodies, a hallmark of Sjögren’s syndrome, are associated with a higher risk of organ involvement in people with scleroderma, including the lungs and skin, a study in Japan shows. The findings suggest “anti-SSA may be a valuable biomarker of organ involvement and skin severity in patients…
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