C0277 - Vibrating Capsule Is Efficacious in Patients With Severe Chronic Idiopathic Constipation (CIC)

Monday, October 24, 2022

3:00 PM – 5:00 PM ET

Location: Crown Ballroom

Has Audio

Presenting Author(s)

Satish Rao, MD

Augusta University
Augusta, Georgia

Satish Rao, MD¹, William D. Chey, MD², Eamonn M. Quigley, MD, MACG³, Anthony Lembo, MD, FACG⁴, Darren Brenner, MD⁵, Brennan Spiegel, MD⁶, Christine Frissora, MD⁷
¹Augusta University, Augusta, GA; ²Michigan Medicine, Ann Arbor, MI; ³Houston Methodist Hospital, Houston, TX; ⁴Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA; ⁵Northwestern Medical Group, Chicago, IL; ⁶Cedars-Sinai Medical Center, Los Angeles, CA; ⁷Cornell University, New York, NY

Introduction: Approximately 50 million Americans report constipation, of whom 28% have moderately severe illness (Am J Gastro 2020;115:895-905). The effectiveness of current therapies for severe chronic idiopathic constipation (CIC) is unknown. In a recent Phase III trial, a vibrating capsule (VC) proved superior to placebo in improving bowel and abdominal symptoms in patients with CIC. Aim: To determine the efficacy and safety of VC in patients with severe CIC.

Methods: We performed a post-hoc analysis of CIC patients (Rome III) who were enrolled in an 8-week phase 3, multicenter, double-blind trial, and randomly received one VC (Vibrant, Yokneam, Israel) or placebo orally for 5 days/week. Severe CIC was defined as patients who reported 0 complete spontaneous bowel movements (CSBM) during a 2-week baseline period on a daily electronic stool diary. Patients with history of dysphagia or bowel obstruction were excluded. Primary outcome measures were percentage of subjects with an increase of one (CSBM₁), two (CSBM2), or three (CSBM3) CSBM/week, during at least 6 of 8 treatment weeks compared to baseline. Secondary outcomes and safety were also assessed.

Results: 312 CIC patients were enrolled of whom 56% (VC n=89, placebo n=86) had severe CIC. There were significantly greater CSBM1 (p=0.0007), CSBM2 (p=0.0040), and CSBM3 (p=0.0176), responders in the VC group compared to placebo (Fig). The straining effort (p=0.0027) and stool consistency (p=< .0001) also improved significantly in the VC group compared to placebo. Also, QOL significantly improved in the VC group (p=< .0001) compared to placebo. The treatment was generally safe, without severe adverse events or diarrhea. The most common AEs in the group were a sensation of mild vibration (11.2%) and abdominal discomfort (2.25%), table 1.

Discussion: In individuals with severe CIC, VC significantly improved bowel and abdominal symptoms and QOL compared to placebo. The VC was safe and well tolerated. Vibrating Capsule is a first in class, novel, non-pharmacological treatment that is efficacious and safe in patients with severe chronic constipation.

Figure: Figure 1: Primary outcome measures showing proportion of CSBMs responders with severe constipation

Adverse event	Vibrating Capsule, Mode 1 (n=89) No. of patients (%)	Placebo (n=86) No. of patients (%)
Adverse events during treatment (combined safety populations including interim analysis groups).*
Any event	23 (25.84)	15 (17.4)
Sensation of vibration**	10 (11.24)
Headache	1 (1.12)	1 (1.16)
Urinary tract infection	1 (1.12)	1 (1.16)
Abdominal pain		2 (2.23)
Abdominal discomfort	2 (2.25)
Vomiting	2 (2.25)	1 (1.16)
Nausea	3 (3.37)	1 (1.16)
Abdominal distention		2 (2.23)
Diarrhea	2 (2.25)
Covid-19	1 (1.12)	1 (1.16)
Nasopharyngitis/Bronchitis	2 (2.25)
Musculoskeletal		1 (1.16)
Data shown for adverse events in at least 1% of the subjects * Sensation of vibration means: ``I think I felt vibration``

Table: Table 1. Adverse events in severe CIC population

Disclosures:

Satish Rao: Salix Pharmaceuticals – Grant/Research Support. Vibrant – Advisor or Review Panel Member. Vibrant – Clinical Advisory Board.

William Chey: Abbvie – Consultant. Allakos – Consultant. Alnylam – Consultant. Arena – Consultant. Biomerica – Consultant. Commonwealth Diagnostics International – Consultant. Gemelli – Consultant. GI OnDEMAND – Stock Options. Ironwood – Consultant. Isothrive – Consultant. Isothrive – Stock Options. Modify Health – Stock Options. Nestle – Consultant. Phathom – Consultant. Progenity – Consultant. QOL Medical – Consultant, Grant/Research Support. Redhill – Consultant. Salix – Consultant, Grant/Research Support. Urovant – Consultant. Vibrant – Consultant.

Eamonn Quigley: Biomerica – Grant/Research Support. Vibrant – Advisor or Review Panel Member. Vibrant – Clinical Advisory Board.

Anthony Lembo: Alkermes – Consultant. Arena Pharmaceuticals, Inc. – Consultant. Bayer – Consultant. Bristol-Myers Squibb – Stock Options. Gemelli Biotech – Consultant. Ironwood Pharmaceuticals, Inc. – Consultant. Johnson & Johnson – Stock Options. OrphoMed, Inc. – Consultant. Salix Pharmaceuticals, Inc. – Consultant. Shire, a Takeda company – Consultant. Takeda Pharmaceuticals – Consultant. Vibrant – Advisor or Review Panel Member. Vibrant Pharma Inc. – Consultant.

Darren Brenner: Salix Pharmaceuticals – Consultant. Vibrant – Advisor or Review Panel Member.

Brennan Spiegel: Ironwood Pharmaceuticals – Advisory Committee/Board Member, Grant/Research Support. Pfizer – Grant/Research Support. Takeda Pharmaceuticals – Advisory Committee/Board Member, Grant/Research Support.

Christine Frissora indicated no relevant financial relationships.

Satish Rao, MD¹, William D. Chey, MD², Eamonn M. Quigley, MD, MACG³, Anthony Lembo, MD, FACG⁴, Darren Brenner, MD⁵, Brennan Spiegel, MD⁶, Christine Frissora, MD⁷. C0277 - Vibrating Capsule Is Efficacious in Patients With Severe Chronic Idiopathic Constipation (CIC), ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.