Core Insights - Herantis Pharma has been selected to lead a consortium for a EUR 8.0 million grant from the Horizon Europe 2025 Research and Innovation program to support a Phase 2 proof-of-concept trial of HER-096 in Parkinson's disease [1][2][3] Funding and Study Details - The funding will facilitate a Phase 2, double-blind, placebo-controlled, randomized efficacy and safety study of HER-096 in early-stage Parkinson's disease patients [2] - The study will commence once necessary preparations, including regulatory approvals, are completed [2] Company Background and Product Information - Herantis Pharma is a clinical-stage biotechnology company focused on developing disease-modifying therapies for Parkinson's disease, with HER-096 as its lead product [7][8] - HER-096 is a first-in-class small peptide designed to mimic the activity of cerebral dopamine neurotrophic factor (CDNF) and is administered subcutaneously [7][9] - Previous clinical trials have shown HER-096 to be generally safe and well-tolerated, with promising preclinical results indicating its potential to stop disease progression and improve patient quality of life [11][10] Horizon Europe Initiative - The Horizon Europe initiative aims to accelerate the translation of biotech research into clinical development, focusing on faster access to innovative therapies, increasing clinical trials in the EU, and enhancing the competitiveness of SMEs in the health biotech sector [6]

Core Insights - Herantis Pharma Plc has announced promising biomarker data from its Phase 1b trial of HER-096, indicating a biological response in patients with Parkinson's disease [2][3][4] Group 1: Clinical Trial Results - The Phase 1b trial involved 24 patients with Parkinson's disease, who received either HER-096 or a placebo twice weekly over four weeks, generating over 2.5 million datapoints for analysis [6][7] - The biomarker data demonstrated significant shifts in disease-relevant pathways, including proteostasis, mitochondrial function, and neuroinflammation, aligning with the expected mechanism of action for HER-096 [5][9] Group 2: Future Development Plans - The encouraging results from the Phase 1b trial support the advancement of HER-096 into a Phase 2 clinical trial planned for 2026, aimed at evaluating efficacy, safety, and tolerability in early-stage Parkinson's patients [10] - The data will inform dose selection and clinical endpoint refinement for future studies, as well as guide the prioritization of biomarkers for confirmation in subsequent trials [7][8] Group 3: Company Statements - Antti Vuolanto, CEO of Herantis, emphasized that the biomarker evidence de-risks the program for potential partners and investors, reinforcing confidence in the long-term value of HER-096 [4] - Henri Huttunen, CSO of Herantis, noted that the findings provide translational evidence of biologically meaningful changes, consistent with preclinical data, and strengthen the therapeutic rationale for HER-096 as development progresses [5]

Core Insights - Herantis Pharma has successfully completed a six-month preclinical Good Laboratory Practice (GLP) toxicology study for its lead clinical asset, HER-096, demonstrating a favorable safety and tolerability profile, which supports its advancement towards a Phase 2 clinical efficacy trial [1][2] - The completion of the toxicology study is a significant milestone in the HER-096 program, providing a strong foundation for further clinical development following positive results from the Phase 1b trial [2][3] - HER-096 is a first-in-class small peptide designed to mimic the activity of cerebral dopamine neurotrophic factor (CDNF), with the potential to stop the progression of Parkinson's disease and improve patients' quality of life [5][8] Preclinical and Clinical Development - The preclinical toxicology study results align with previous preclinical and clinical data, reinforcing confidence in HER-096's long-term administration suitability [1][2] - The Phase 1b trial of HER-096 met all primary and secondary endpoints, with pharmacokinetic data consistent with healthy volunteers and confirmed efficient brain penetration [3][4] - Herantis plans to initiate a Phase 2 clinical trial in 2026 to evaluate the efficacy, safety, and tolerability of HER-096 in early-stage Parkinson's patients [4][8] Funding and Support - The completion of the preclinical toxicology program marks the final milestone of the EIC Accelerator Grant project, which provided EUR 2.5 million to support the development of HER-096 and its biomarker program [2][3] - The biomarker development results have already been applied in exploratory analyses within the Phase 1b clinical trial, enhancing the overall research framework [2][3] Mechanism of Action - HER-096 operates through a multimodal mechanism targeting key drivers of neurodegeneration in Parkinson's disease, including modulation of the Unfolded Protein Response (UPR) pathway and reduction of neurotoxic protein aggregation [6][7] - The compound has shown compelling preclinical results, demonstrating its neurorestorative potential and favorable safety profile following subcutaneous administration [7][8]

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]

Core Viewpoint - Herantis Pharma Plc has initiated the final cohort of its Phase 1b clinical trial for HER-096, a potential disease-modifying therapy for Parkinson's disease, with the first patients dosed, aiming to report topline data by September 2025 [3][4][9]. Group 1: Clinical Trial Details - The Phase 1b trial consists of two parts: Part 1 involved eight healthy volunteers receiving a single 300 mg subcutaneous dose to assess safety and pharmacokinetics, while Part 2 is a randomized, double-blind, placebo-controlled trial in Parkinson's patients [6][7]. - In Part 2, the first cohort included 12 patients dosed twice weekly over four weeks, with eight receiving 200 mg of HER-096 and four receiving placebo, leading to the Data and Safety Monitoring Board's recommendation to proceed to the final cohort [6][8]. - The primary objective of the Phase 1b trial is to evaluate the safety, tolerability, and pharmacokinetics of repeated subcutaneous doses of HER-096, along with monitoring symptom progression using MDS-UPDRS and wearable devices [7][8]. Group 2: HER-096 Overview - HER-096 is a first-in-class synthetic peptidomimetic designed to mimic the activity of cerebral dopamine neurotropic factor (CDNF), capable of crossing the blood-brain barrier and allowing for convenient subcutaneous administration [5][11]. - The drug has a multi-modal mechanism of action that may protect against neuronal degeneration and cell death associated with Parkinson's disease, potentially halting disease progression and improving patients' quality of life [5][11]. - The ongoing Phase 1b trial builds on positive results from the Phase 1a trial, which demonstrated a good safety and tolerability profile, as well as effective blood-brain barrier penetration of HER-096 in healthy volunteers [10][12]. Group 3: Funding and Support - The Phase 1b trial is funded by the Michael J. Fox Foundation for Parkinson's Research and Parkinson's UK, indicating strong support from prominent organizations in the field [8][9]. - The trial is being conducted in Turku and Helsinki, Finland, by Clinical Research Services Turku – CRST Oy, showcasing collaboration with established research organizations [9].