Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon‘s Torax Medical business today released results from the Caliber trial of its Linx system for treating gastro-esophageal reflux disease, touting quality of life improvements and reduction in reflux levels.
The Linx system is an implant composed of interlinked titanium beads with magnetic cores that augments the esophageal sphincter’s barrier function to prevent reflux in patients with gastro-esophageal reflux disease, the company said.
Data from the trial was presented at the Digestive Disease Week 2017 meeting in Chicago.
The randomized, controlled, 150-patient Caliber trial compared Linx to acid suppression medication omeprazole in patients diagnosed with GERD with troublesome regurgitation. The primary endpoint of the trial was elimination of moderate to severe regurgitation at 6 months post-treatment.
Preliminary results from the trial indicated that 92.6% of patients treated with Linx achieved the primary endpoint, while only 8.6% of patients treated with twice a day omeprazole did.
Quality of life improvements were recorded in 88.9% of patients treated with Linx, versus only 6.8% of patients on omeprazole. Normal reflux levels were restored in 92% of Linx patients, and 36% of omeprazole patients, according to study data.
“PPIs are intended for acid suppression, not reflux control. The Caliber study is effectively showing that patients with troublesome regurgitation appear to significantly benefit from the reflux control provided by Linx over omeprazole which primarily affects gastric acidity,” CEO Todd Berg said in a prepared statement.
“Current practice for GERD patients with troublesome regurgitation is to increase the dose of acid suppression therapy. The preliminary results of this study demonstrate a 10-fold better resolution of regurgitation with Linx compared to increases in acid-suppression therapy. If the significant disparity in outcomes observed in this preliminary analysis continues to favor Linx, the medical community will need to recognize that increasing PPI dosing for these patients is largely ineffective. A paradigm shift will occur that will greatly favor the reflux control provided by Linx,” principal investigator Dr. Reginald Bell said in a press release.
Torax Medical said that additional results from the trial will be available later this year.