Is Meta-Analysis a Sign of Something Big on the Horizon for GID?

GI Dynamics has been increasing its activity lately by raising offerings and getting favorable data published for its EndoBarrier, an obesity treatment device.

All signs are pointing to something big on the horizon for GI Dynamics and its embattled obesity and type 2 diabetes treatment technology. The most recent guidepost from the Lexington, MA-based company came Thursday, when it announced results were being published from a meta-analysis of the EndoBarrier. Results show the device was able to impact weight loss and insulin resistance improvement.

The research is titled “Effects of the Duodenal-Jejunal Bypass Liner on Glycemic Control in Type 2 Diabetic Patients with Obesity: A Meta-analysis with Secondary Analysis on Weight Loss and Hormonal Changes,” and has been published in Diabetes Care, the journal of the American Diabetes Association. The results were first presented by Pichamol Jirapinyo, M.D., Division of Gastroenterology, Hepatology and Endoscopy at Brigham and Women’s Hospital and Harvard Medical School in Boston during Digestive Disease Week (DDW) in May of last year.

GI Dynamics' EndoBarrier works by creating a barrier between food and the wall of the small intestine and thereby changes metabolic pathways by controlling how food moves through the digestive system. The effects are supposed to be similar to gastric bypass surgery, but without the surgical procedure and hospital stay.

The firm's meta-analysis is comprised of 17 published studies that evaluate EndoBarrier outcomes in patients with type 2 diabetes and obesity. Primary outcomes of the meta-analysis were change in hemoglobin A1c (HbA1c) and homeostatic model assessment of insulin resistance (HOMA-IR). Secondary outcomes were change in weight and change in hormones critical to the regulation of metabolic and bariatric disorders.

“The analysis shows that [the EndoBarrier] is effective at treating diabetes in this patient population with a reduction in HbA1c of 1.3%, and with many patients coming off diabetic medication,” Jirapinyo said in a release. “This reduction in HbA1c is significantly better by 0.9% as compared to optimal medical management alone. In addition, this study demonstrates that patients who receive [the EndoBarrier] experience significant improvements in insulin resistance and weight loss, which persist up to at least six months after device removal.”

For the past few months GI Dynamics has been involved in a string of activities that suggest the Boston-based is on its way toward drumming up interest for the embattled EndoBarrier. The rumblings started in early March, when GI Dynamics shareholders approved a $2 million offering. Just a few days ago, the company announced a $1.75 million financing commitment from Crystal Amber Fund, according to a release.

The obesity-treatment device has been under intense scrutiny, with issues dating back to 2015. It was during this time FDA placed a hold on a pivotal trial because of four cases of hepatic abscess that occurred in patients. The news tanked GI Dynamics’ stock – but this was only the beginning of the company’s woes.

The suspension of the pivotal trial also caused the company to cut its headcount by 48% to 36. And about a year ago, the company received word its CE mark was being suspended because of pending resolution of nonconformances related to ISO 13485 compliance. GI Dynamics eventually lost its CE mark in Nov. of 2017.

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