Herantis Pharma presents positive topline data for HER-096 in Phase 1b trial for people living with Parkinson’s disease

Core Insights - Herantis Pharma announced positive topline results from its Phase 1b trial of HER-096 for Parkinson's disease, meeting all primary and secondary endpoints, which establishes a strong foundation for advancing to Phase 2 trials in 2026 [2][4][6] Summary by Sections Trial Results - The Phase 1b trial demonstrated that both 200 mg and 300 mg doses of HER-096 are generally safe and well tolerated in Parkinson's disease patients, with adverse events primarily being mild and transient [6][7] - The pharmacokinetic profile of HER-096 was consistent with predictions from single-dose studies, confirming blood-brain barrier penetration in patients [6][7] - A twice-weekly dosing regimen with a 300 mg dose is deemed suitable for the upcoming Phase 2 trial [6] Future Plans - Based on the encouraging Phase 1b results, Herantis plans to advance HER-096 into a Phase 2 clinical trial in 2026 to evaluate its efficacy, safety, and tolerability in early-stage Parkinson's patients [2][4][11] - The full dataset, including exploratory biomarker data, is expected to be available before the end of 2025 [8] Mechanism of Action - HER-096 is a first-in-class small peptide designed to mimic the activity of cerebral dopamine neurotrophic factor (CDNF), which promotes neuronal cell survival and functional recovery [11][12] - The drug targets key drivers of neurodegeneration in Parkinson's disease by modulating the Unfolded Protein Response pathway, reducing aggregation of neurotoxic protein α-synuclein, and modulating neuroinflammation [12]