Safety Data of Iclepertin (BI 425809) From Phase I Healthy Volunteers and Phase II Patients with Cognitive Impairment Associated with Schizophrenia (CIAS)
Introduction: Iclepertin (BI 425809) is a GlyT1 inhibitor in Phase III development for CIAS.
Aims: To assess the safety of iclepertin in Phase I (Nf391 healthy volunteers [HV]; 339 iclepertin-treated, 52 placebo-controlled) and Phase II trials (Nf709 patients with CIAS; 438 iclepertin-treated, 271 placebo-controlled).
Methods: Descriptive statistics.
Results: In Phase I, 198 (58.4%) iclepertin-treated and 17 (32.7%) placebo-controlled HVs reported adverse events (AEs), 4 (1.2%) severe and 125 (36.9%) defined as drug-related. Ten (2.9%) AEs led to treatment discontinuation. No AEs of special interest (AESI) or serious AEs (SAE) were reported. No suicidal ideation or behavior was reported.
In Phase II, 204 (46.6%) iclepertin-treated patients with CIAS versus 131 (48.3%) placebo-treated patients reported any AEs. Ten (2.3%) treated patients versus 3 (1.1%) placebo-controlled patients reported AEs of severe intensity and 76 (17.4 %) versus 50 (18.5%) were drug-related. Fourteen (3.2%) versus 8 (3.0%) patients discontinued treatment due to AEs. One (0.2%) AESI occurred on iclepertin, 0 on placebo. Thirteen (3.0%) vs 6 (2.2%) SAEs have been reported. The most common preferred terms were headache (40 [9.1%] vs 20 [7.4%]), somnolence (17 [3.9%] vs 7 [2.6%]), dizziness (17 [3.9%] vs 6 [2.2%]), and nasopharyngitis (29 [6.6%] vs 14 [5.2%]). Suicidal ideation was reported in 1 (0.2%) iclepertin-treated and 3 (1.1%) placebo-controlled patients.
Conclusions: Iclepertin was well tolerated by both populations. No dose-dependent trends were observed for the overall number of AEs. No meaningful changes were observed in the analyzed ocular safety and hemoglobin parameters versus placebo.
Funding: Boehringer Ingelheim Pharmaceuticals, Inc.
