AMG 378 / Amgen - LARVOL DELTA

Boehringer, Amgen discard early immunology candidates over lack of clinical potential (FierceBiotech) - "Germany drugmaker Boehringer has halted development of the oral immune modulator BI 3009947, terminating a phase 1 trial that had enrolled 40 healthy men....'The clinical data does not support further investigation and there were no safety concerns'....Amgen likewise stopped a phase 1 study of oral small-molecule AMG 378 that had enrolled 48 healthy volunteers....The molecule was being studied for its potential in ulcerative colitis, according to an archived version of Amgen’s pipeline."

Discontinued • Immunology • Ulcerative Colitis

Single and Multiple Ascending Dose Study of AMG 378 in Healthy Participants (clinicaltrials.gov) - P1 | N=48 | Terminated | Sponsor: Amgen | Recruiting ➔ Terminated | Trial primary completion date: Sep 2026 ➔ Jan 2026 | N=92 ➔ 48 | Trial completion date: Oct 2026 ➔ Jan 2026; Business Decision

Enrollment change • Trial completion date • Trial primary completion date • Trial termination

Single and Multiple Ascending Dose Study of AMG 378 in Healthy Participants (clinicaltrials.gov) - P1 | N=92 | Recruiting | Sponsor: Amgen | Trial completion date: Oct 2028 ➔ Oct 2026 | Trial primary completion date: Oct 2028 ➔ Sep 2026

Trial completion date • Trial primary completion date