US-based clinical-stage healthcare company SetPoint Medical has reported positive topline results from the RESET-RA clinical study of its SetPoint System.

SetPoint System is a neuroimmune modulation device that showed a clinical benefit in adults living with moderate-to-severe rheumatoid arthritis (RA).

RESET-RA is a two-staged, multicentre, randomised, sham-controlled, double-blind clinical trial that enrolled a total of 242 patients across 41 sites in the US.

The study evaluated the system as a potential neuroimmune modulation treatment for RA patients who are intolerant to disease-modifying anti-rheumatic drugs (DMARDs).

In the study, a significant proportion of participants achieved an ACR20 response in the treatment group compared with the control group at 12 weeks, which is the primary endpoint.

ACR20 response is a composite measure of the effectiveness of RA treatments, introduced by the American College of Rheumatology.

SetPoint Medical chief medical officer David Chernoff said: “Despite multiple treatment options, including biologic therapies and oral Janus kinase (JAK) inhibitors, there continue to be challenges and unmet medical needs in managing rheumatoid arthritis.

“A significant proportion of patients either do not adequately respond to or are intolerant to currently approved treatment options.

“Approved therapies can also have serious immunosuppressive risks leading to safety concerns, poor patient satisfaction, and low treatment adherence.”

RA is a chronic autoimmune condition where the body’s immune system attacks its own tissue, causing pain, bone erosion, joint deformity, diminished function, and long-term disability.

The SetPoint System features an implantable, rechargeable neurostimulation device that electrically stimulates the vagus nerve once daily.

The stimulation activates innate anti-inflammatory and immune-restorative pathways, to treat autoimmune conditions without the risks associated with pharmacological therapies.

Once the neurostimulation device is placed during an outpatient procedure, the system can be programmed to automatically deliver therapy on a preset schedule, said the company.

After the completion of the primary endpoint at 12 weeks, the study is being continued to assess the long-term safety and effectiveness of the device in an open-label extension study.

The SetPoint System has received the US Food and Drug Administration (FDA) Breakthrough Device Designation for the treatment of patients with moderate-to-severe RA.

SetPoint Medical CEO Murthy Simhambhatla said: “We are thrilled with the results from the RESET-RA study as they highlight the potential of the SetPoint System for providing rheumatologists and their patients with a safe and effective treatment alternative to current rheumatoid arthritis therapies.

“As next steps, we look forward to submitting the data for presentation at upcoming rheumatology and neurosurgical medical meetings and completing our premarket approval submission to the FDA.”