Recently, results from a phase 2a study evaluating SGX945 (dusquetide) for the treatment of Behçet’s disease were published in Rheumatology (Oxford).
Behçet’s disease is a rare vasculitis characterized by inflammation and swelling of blood vessels. It often affects multiple organs in the body, such as the skin, mucous membranes, eyes, joints, gastrointestinal system, and nervous system. Common symptoms include mouth and genital ulcers, skin lesions, joint pain and swelling of the eyes. If untreated, the condition can cause serious complications, such as blindness. Behçet’s disease may be an autoimmune disorder, but it is likely that gene changes and factors in the environment also play a role.
Dusquetide is an innate defense regulator synthetic peptide. Its mechanism of action addresses the modulation of the body’s reactions to injury and infection towards anti-inflammatory, anti-infective, and tissue healing responses. The open-label phase 2a study evaluated the safety and efficacy of dusquetide for the treatment of oral and genital ulcers in Behçet’s disease.
Beneficial effects were observed in 7 out of 8 patients over 4 weeks of treatment, as well as a potentially enduring effect through 4 weeks of follow-up. The phase 3 study of apremilast, the most recently approved treatment for Behçet’s disease, was used as a baseline for comparison.
The average number of oral ulcers and improvements in oral pain for dusquetide were similar to outcomes in the apremilast study. Outcomes in weeks 5 through 8 continued to show similar outcomes, even though apremilast treatment was continued through this period and dusquetide treatment was stopped at week 4.
The primary endpoint in the apremilast study was the area under the curve (AUC) of the mean number of ulcers versus time. Utilizing this same endpoint after 4 weeks of treatment, the dusquetide group had a 40% improvement relative to the placebo group from the apremilast study, compared to a 37% improvement in the apremilast study relative to placebo. Additionally, this improvement was sustained through the 4-week follow-up after treatment with dusquetide, with 32% improvement evaluated at week 8, compared to apremilast, with a 41% improvement at week 8.
Similar results were seen in oral pain, where 7 out of 8 patients reported perceived benefit with dusquetide. Common outcomes included reduced duration of oral ulcers, reduced number of oral ulcers, and reduced oral pain.
Dusquetide was well-tolerated with no treatment-related adverse events. This is compared to apremilast, where common adverse events include diarrhea, nausea, and headache.
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To learn more about Behcet’s disease, and other rare hematological conditions, visit https://checkrare.com/diseases/hematologic-disorders/
