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news.sterna biological has reported positive results from the SECURE study, a Phase 2a trial in patients with moderate to severe ulcerative colitis treated with its GATA-3 specific DNAzyme formulation SB012.
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SECURE study is a prospective, multi-center, randomized and double-blind placebo-controlled trial designed to assess patients with moderate to severe ulcerative colitis.
SB012 is an enema formulation of hgd40, which is a new DNAzyme that specifically binds and inactivates GATA-3 mRNA and subsequent GATA-3 protein expression.
GATA-3 is the master transcription factor that can regulate Th2-driven inflammatory diseases such as ulcerative colitis, atopic dermatitis, eCOPD and asthma.
DNAzymes are single-stranded DNA molecules, which includes central catalytic domain surrounded by two binding domains.
The binding domains bind to a specific sequence of targeted mRNA such as GATA-3 mRNA in case of hgd40. Later, the catalytic domain cleaves the mRNA to inhibit relevant downstream cytokine expression
The company has randomized 20 patients to receive topically applied SB012 enema or placebo once daily for 28 days.
The primary efficacy variable was the change in disease activity after 28 days of treatment, said the company. Endpoints in the trial have been evaluated at day 56.
According to sterna, there was a statistically significant improvement in the Mayo Score in the SB012 at day 28 compared against the placebo group.
sterna biological managing director Christian Pangratz said: "The data from this Phase 2a trial provide clinical proof of concept that blocking transcription factor GATA-3, which is overexpressed in the mucosa of ulcerative colitis patients, could offer a new approach to tackling this difficult disease.
“These encouraging results, together with the efficacy already demonstrated in previous clinical studies with different topical formulations of hgd40 in asthma and COPD, are a strong validation of the GATA-3 pathway for the treatment of a variety of chronic inflammatory diseases.”
sterna biological is engaged in the development of novel treatments for chronic inflammatory diseases such as asthma, COPD, atopic dermatitis and ulcerative colitis.