US-based NeuroPace has reported the initial primary endpoint one-year outcomes from the two-year NAUTILUS trial of the RNS System for treating individuals with drug-resistant idiopathic generalised epilepsy (IGE).
This prospective, single-blind, sham stimulation-controlled, multi-centre trial involving 100 subjects, 87 of whom received the RNS System implant across 23 US epilepsy centres, has met its primary 12-week post-implant safety endpoint.
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It has shown a low serious adverse event rate related to the device and implant procedure, and is in line with the established safety profile of the system.
Although the trial did not reach statistical significance for the primary effectiveness endpoint in the overall subjects, a significant response was observed within a subgroup of subjects with a lower baseline frequency of generalised tonic-clonic seizures.
The trial also revealed clinically relevant data such as median per cent seizure decrease and improvement in seizure-free days, indicating improvements over the first year of treatment.
These improvements continued into the second year for those who had progressed in the trial.
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By GlobalDataThe one-year preliminary data from the trial underscores the system’s ability to individualise treatment through programming over time.
NeuroPace noted that the observed metrics were favourable when compared to its randomised controlled trial in focal epilepsy, which led to the US Food and Drug Administration’s (FDA) approval.
Subjects who have completed over one year in the trial have shown continued clinical improvement, consistent with previous outcomes from the RNS System in the focal epilepsy subjects.
In 2021, NeuroPace secured FDA breakthrough device designation status for the RNS System’s potential use in treating IGE.
The company plans to engage in discussions with the agency regarding regulatory pathways based on the study data, which may include utilising overall median seizure reduction data or pursuing a targeted indication for those with lower baseline seizure frequency.
NeuroPace CEO Joel Becker said: “We view the totality of the data in the NAUTILUS study as a meaningful catalyst that adds to the growing body of evidence and momentum in our business.
“With a strong base business growing over 20% year over year, we remain confident in our long-term growth strategy and excited by the opportunity ahead.”
