Research & Development
Gelesis Touts Promising Clinical Data from Pilot Study of Novel Hydrogel GS500 Prototype for the Potential Treatment of Chronic Constipation
21 May 2019 - - US-based biotechnology company Gelesis has presented data from a clinical study demonstrating that GS500 prototype (GS500/CSP01) provided a significant reduction in colonic transit time in patients with chronic idiopathic constipation relative to placebo, the company said.

The data were presented at Digestive Disease Week 2019, held in San Diego, California.

Gelesis' proprietary hydrogel product candidates are orally administered and synthesized from two naturally derived building blocks modified cellulose cross-linked with citric acid that create a three-dimensional matrix designed to achieve specific mechanical properties (high elastic response) through the gastrointestinal system.

In order to assess the potential therapeutic benefits of the hydrogel's specific mechanical properties, modified cellulose, the main building block of GS500, was included as an active control.

This modified cellulose is a widely used soluble dietary fiber but lacks the three dimensional structure of the superabsorbent hydrogel, and therefore creates significantly lower elastic response.

The primary end-point of this randomized, double-blind study was the change in CTT from pre-treatment to post-treatment as measured by wireless motility capsules. The test involves swallowing a small data recording device which transmits information to a wireless data receiver.

Two populations were evaluated separately, 27 subjects with CIC and 13 subjects with irritable bowel syndrome with constipation (IBS-C).

Patients were randomized into three treatment groups to receive 21 days of treatment with either GS500, active control (modified cellulose, n=11) or placebo.

Each subject's CTT was measured during the third week of treatment and compared to their baseline, collected during 7 days of pre-treatment. Secondary outcome measures included improvement of relevant gastro intestinal symptoms.

In the CIC population on treatment, colonic transit time was reduced by approximately 16 hours compared to baseline (P=0.02 compared to placebo).

No statistically significant change was observed in the placebo or the active control groups.

No improvement was observed in the IBS-C population, as well as no change in the reported GI symptoms which were the secondary endpoints.

Two randomised patients did not complete the study, one in the treatment group due to a GI related AE, and one in the placebo group due to a faulty monitoring device. No serious adverse events were reported.

This pilot study of 40 subjects was powered to detect improvement in CTT (the primary end-point). Recent data suggest that colonic transit time influences gut health and a longer fecal retention time is associated with CIC symptoms and less microbiome diversity.

Further studies are required to assess the effect of Gelesis' hydrogel technology on symptom improvement.

Gelesis is developing a novel hydrogel platform technology to treat overweight and obesity and chronic diseases related to the GI pathway. Gelesis' proprietary approach is designed to act mechanically in the GI pathway to potentially alter the course of chronic diseases.

In April 2019, Gelesis received FDA clearance for its lead product candidate, PLENITY. Gelesis is preparing to initiate a targeted US launch of PLENITY in the second half of 2019 and anticipates PLENITY will be broadly available by prescription in the US in 2020.

Additionally, Gelesis is developing its second candidate, Gelesis200, a hydrogel optimized for weight loss and glycemic control in patients with type 2 diabetes and prediabetes.

Novel hydrogel mechanotherapeutics based on the Gelesis platform technology are also being advanced through a pipeline (GS300, GS400, GS500) in other GI inflammatory conditions where gut barrier and gut permeability potentially play a role, such as non-alcoholic steatohepatitis and inflammatory bowel disease.

Recent preclinical data presented this year support the potential role of this novel hydrogel platform technology in restoring gut barrier function and intestinal tissue health.

The Gelesis executive and advisory team includes some of the world's leading experts in obesity, materials science, chronic disease research and commercialisation. Gelesis was co-founded by PureTech Health (LSE: PRTC), a biopharmaceutical company focused on the Brain-Immune-Gut Axis.
Login
Username:

Password: