Migd-061 ((new)) < 720p × 480p >

The ISR orchestrates cellular adaptation to amino‑acid deprivation, oxidative stress, and viral infection. Hyper‑activation of GCN2 has been linked to tumor immune evasion (via PD‑L1 up‑regulation), chronic neurodegeneration, and viral replication. Consequently, selective GCN2 inhibition is being explored for oncology, neuro‑inflammation, and infectious disease.

| Species | Study | No‑Observed‑Adverse‑Effect Level (NOAEL) | Findings | |---------|-------|-------------------------------------------|----------| | | Oral (0.5‑100 mg/kg/day) | 30 mg/kg/day | No clinical signs; mild hepatocellular vacuolation at 100 mg/kg (reversible). | | Dog (90‑day) | Oral (1‑50 mg/kg/day) | 10 mg/kg/day | No mortality; transient increase in serum bilirubin at 50 mg/kg (resolved). | | Genotoxicity | Ames, Chromosome Aberration, Micronucleus | Negative across assays. | | Cardiac safety | hERG assay (IC₅₀ ≈ > 30 µM) | No QTc prolongation in telemetry‑monitored dogs (up to 20 mg/kg). | | Reproductive toxicity | Rat embryo‑fetal (GD 6‑15) | 20 mg/kg/day | No teratogenicity; slight decrease in fetal weight at highest dose (statistically non‑significant). | migd-061

Total Addressable Market (TAM) for the combined indications exceeds , with | | Cardiac safety | hERG assay (IC₅₀

, a unit of measurement for water flow or capacity. If this is a reference to a specific technical manual or industrial model (such as a pump or water treatment component), it may be an internal company identifier. If you intended to "create text" using a specific software or tool that uses this ID, please provide a bit more context about the platform or industry. In the meantime, if you are looking for general instructions on adding text to digital assets, here are common methods: Microscope Imaging (ImageJ/FIJI) ALS) | Randomized

Published under the MOODYZ label, specifically within the MIGD series. Runtime: Approximately 120 minutes. Director: Katsuyuki Hasegawa. Context of the MIGD Series

| Trial | Design | Status (as of Apr 2026) | Key Findings | |-------|--------|--------------------------|--------------| | (Phase I, First‑in‑Human) | Open‑label, dose‑escalation (5‑100 mg QD) in healthy volunteers (n = 48) | Completed (Dec 2024) | - Safety: No SAEs; Grade 1‑2 AEs: headache (15 %), nausea (12 %), transient ALT↑ (3 %). - PK: Linear exposure; Cmax at 2‑3 h; t½ ≈ 7 h (human). - PD: Dose‑dependent reduction of p‑eIF2α in PBMCs; > 80 % inhibition at ≥ 30 mg. | | NCT05922389 (Phase I/II, Oncology) | 3 + 3 escalation (15‑60 mg QD) + expansion in advanced solid tumours (n = 68) receiving pembrolizumab | Ongoing (enrollment 2nd cohort) | - DLT: None reported at 30 mg; one Grade 3 ALT elevation at 60 mg (resolved). - Preliminary efficacy: 2 PRs (lung SCC, colorectal) and 5 SDs lasting ≥ 4 months in the 30 mg cohort (overall response rate ≈ 3 %). | | NCT06000112 (Phase I, ALS) | Randomized, double‑blind, 30 mg vs. placebo QD (n = 24) | Initiated (Feb 2025); interim analysis pending | - Primary endpoint: safety and tolerability. - Exploratory biomarker: CSF ATF4 levels trending down in treatment arm. |