GS-1427 / Gilead - LARVOL DELTA

Pharmacokinetics, Safety, and Tolerability of GS-1427, an Oral Prodrug of a Potent and Selective α4β7 Integrin Inhibitor, in Healthy Participants. (PubMed, J Clin Pharmacol) - "The bioavailability of tablet versus capsule formulations and the effect of food and an acid-reducing agent (omeprazole) on exposure were also assessed. All AEs were grade 1 in severity and no serious AEs or deaths were reported. The pharmacokinetics, safety, and tolerability results from this study support further evaluation of GS-1427 in a phase 2 trial in patients with UC."

Clinical • First-in-human • Journal • PK/PD data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

SWIFT: Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=228 | Active, not recruiting | Sponsor: Gilead Sciences | Trial completion date: Jul 2027 ➔ Apr 2028

Trial completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

SWIFT: Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=228 | Active, not recruiting | Sponsor: Gilead Sciences | Recruiting ➔ Active, not recruiting

Enrollment closed • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

SWIFT: Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=228 | Recruiting | Sponsor: Gilead Sciences | Trial completion date: Feb 2027 ➔ Jul 2027 | Trial primary completion date: Oct 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Discovery of GS-1427: A potent and selective, oral α4β7 inhibitor for the treatment of inflammatory bowel disease (ACS-Fall 2025) - "This pathway has been clinically validated for the treatment of inflammatory bowel disease (IBD) with the approval of vedolizumab, a monoclonal antibody that targets α4β7 disrupting its binding to MadCAM-1. GS-1427 demonstrates in vivo activity comparable to an antibody control in a preclinical model of T cell gut trafficking, and is efficacious in a murine IBD disease model. This presentation will describe the discovery, preclinical evaluation, and early clinical data for GS-1427, which is currently in Phase 2 clinical trials for ulcerative colitis."

Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • ITGA4

SWIFT: Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=228 | Recruiting | Sponsor: Gilead Sciences | N=423 ➔ 228 | Trial completion date: Mar 2028 ➔ Feb 2027 | Trial primary completion date: May 2027 ➔ Oct 2025

Enrollment change • Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

PHASE 1 BIOMARKER ANALYSES OF GS-1427 A NOVEL ORAL Α4Β7 INTEGRIN INHIBITOR FOR INFLAMMATORY BOWEL DISEASE DEMONSTRATE Α4Β7 SELECTIVITY AND ONCE DAILY DOSING (UEGW 2024) - "In conclusion, the exploratory biomarker results in this Phase 1 study in healthy subjects demonstrating extended α4β7 RO and α4β7 selectivity together with the pharmacokinetics, safety, and tolerability data (abstract in preparation) support further development of GS-1427 with a once daily dosing regimen in a Phase 2 study in IBD."

Biomarker • P1 data • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • CD34

SWIFT: Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=423 | Recruiting | Sponsor: Gilead Sciences | Not yet recruiting ➔ Recruiting

Enrollment open • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

SWIFT: Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=423 | Not yet recruiting | Sponsor: Gilead Sciences

Combination therapy • Monotherapy • New P2 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis