Selecta Biosciences is eying a Phase III trial for its gout treatment based on expanded positive data from an ongoing mid-stage trial that showed a significant reduction of serum uric acid at 12 weeks.
Watertown, Mass.-based Selecta Biosciences is eying a Phase III trial for its gout treatment based on expanded positive data from an ongoing mid-stage trial that showed a significant reduction of serum uric acid at 12 weeks.
The data was shown off in a poster presentation at the 2018 European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology in Amsterdam, Netherlands. The data is an expansion of data presented at an early conference, the Pan American League of Associations for Rheumatology, the company said. The data shows that patients treated with three monthly doses of SEL-212, a combination of rapamycin and pegylated uricase (pegsiticase) which was then followed by two monthly doses of pegsiticase alone, reduced serum uric acid in a significant number of patients. Approximately 81 percent of patients treated had serum uric acid control below 6 mg/dl at week 12, the company said. That’s an improvement over data that was first reported in April that showed 75 percent of SEL-212 patients had reduced serum uric acid levels.
With the positive news and plans for a late-stage trial, Selecta is eying a treatment that could potentially challenge Horizon Pharma’s gout treatment Krystexxa. Gout is a form of arthritis that occurs due to the accumulation of urate crystals in the joints. Those crystals form when there are high levels of uric acid in the blood.
Additionally, Selecta said SEL-212 has also shown to be a benefit in reducing gout flares in patients. In its report, Selecta said 27 percent of all current patients in the SEL-212 Phase II trial experienced gout flares during the first month after treatment. Selecta said data shows a continued reduction of gout flare rates over months two to five. What makes this important, Selecta said, is the reduced rate of gout flares “appears to be substantially lower than the incidence of gout flares reported in clinical trials involving the current FDA-approved uricase.” SEL-212 is designed to be the first non-immunogenic version of uricase.
Werner Cautreels, president and chief executive officer of Selecta, said the company is pleased with the continued improvement in clinical activity. Cautreels said the company believes the expanded data further demonstrates “SEL-212’s potential ability to change the chronic severe gout treatment paradigm” by providing greater reduction in serum uric acid levels and better control of gout flares, particularly as it compares to Krystexxa.
“We are now in the fourth treatment cycle of patients receiving five monthly doses of the combination treatment of SEL-212 and plan to report data from those patients at an upcoming medical meeting in the third quarter of this year. Those data have the potential to demonstrate the extended benefit of SEL-212 in chronic severe gout patients with high medical need and position us to execute on our Phase III program, which we plan to start later this year,” Cautreels added.
During clinical trials, SEL-212 has been well tolerated, with only 17 serious adverse events (SAEs) reported. Of those, none were reported to not likely be related to the drug and eight were infusion reactions.
