InMed Advances INM-901 with Q3 2026 Pre-IND Meeting, 2027 Phase 1 Start
InMed Pharmaceuticals generated preclinical data showing INM-901 reduced key inflammatory biomarkers (IFN-γ, TNF-α, IL-1β, NLRP3) and promoted neurite outgrowth with cognitive improvements, supporting its CB1/CB2-targeted neuroinflammation strategy. The company plans a pre-IND FDA meeting in Q3 2026 and aims to file an IND and start a Phase 1 trial in 2027.
1. INM-901 Preclinical Advances
In 5xFAD and LPS-induced neuroinflammation models, INM-901 significantly reduced inflammatory biomarkers IFN-γ, TNF-α, IL-1β, KC-GRO, IL-2, NLRP3 and neurofilament light chain. The candidate also demonstrated neurite outgrowth, protection against amyloid beta–induced cell death, positive cognitive behavioral trends, oral bioavailability and molecular validation supporting enhanced neurogenesis.
2. INM-901 Regulatory and Clinical Outlook
InMed is preparing for a pre-IND meeting with the FDA in Q3 2026 while executing IND-enabling pharmacology, toxicology studies and manufacturing scale-up. Subject to regulatory feedback, the company targets IND submission and initiation of a Phase 1 Alzheimer’s trial in 2027, with clinical design mapped out by external experts.
3. INM-089 Program Progress
INM-089, a small molecule for dry age-related macular degeneration, completed preclinical dose-ranging and pharmacokinetic studies demonstrating dose proportionality and therapeutic systemic exposure. Drug substance and product processes have been established to support upcoming IND-enabling studies, with a pre-IND meeting planned in Q4 2026.