The US pilot study conducted by SetPoint is a multi-center, double-blind, randomized trial aimed at evaluating the safety and tolerability of SetPoint’s miniaturized microregulator device for the treatment of drug refractory RA.
The study has enrolled 14 patients, all of them with active RA and prior insufficient response to two or more biologic or targeted synthetic disease modifying anti-rheumatic drugs (DMARDs) with at least two different modes of action.
The study showed that nine out of 14 patients have failed to respond to the latest class of targeted synthetic DMARDs, Janus kinase (JAK) inhibitors, after failing to respond to biologic DMARDs.
The company said that patients were enrolled in two phases where the first three patients in the open-label phase were implanted and stimulated for one minute, once per day (QD).
After securing approval from the safety review board, the remaining 11 patients were implanted with the device and randomized to one minute of sham, once per day (QD) or four times per day (QID) stimulations through the primary endpoint at 12 weeks.
The data showed that the company’s bioelectronic medicine was well tolerated with no device-related adverse events through 12 weeks.
During the study, the company observed two notable surgery-related events, which were resolved without clinically significant sequelae.
SetPoint Medical president and chief executive officer Murthy Simhambhatla said: “These positive results from our U.S. study mark another step closer to providing a new, potentially efficacious, yet less immunosuppressive treatment option for patients who suffer from RA. More than 1.5 million Americans are diagnosed with RA.
“This development provides a tremendous opportunity to advance a novel alternative for patients diagnosed with RA. Based on these results, we look forward to initiating a larger U.S. study of our device, with plans to follow the Pre-Market Approval (PMA) pathway to FDA approval.”
