HER-096 / Herantis - LARVOL DELTA

Translational Target Engagement of HER-096 Demonstrates Concordant Proteostasis and Mitochondrial Modulation in Preclinical Models and Patients with Parkinson’s Disease (MDS Congress 2026) - No abstract available

Discordant • Preclinical • CNS Disorders • Movement Disorders • Parkinson's Disease

A Phase 1b Study to Investigate Safety, Tolerability and Biomarker Responses of Repeated Subcutaneous Doses of HER-096 in Subjects with Parkinson’s Disease (MDS Congress 2026) - No abstract available

Biomarker • Clinical • P1 data • CNS Disorders • Movement Disorders • Parkinson's Disease

Outlook for 2026 (The Manila Times) - "During the remainder of 2026, the Company will focus on completing activities required to initiate the Phase 2 study, including regulatory submissions, operational preparations and securing additional financing...Herantis expects to initiate the Phase 2 study in the first half of 2027, with the first patient dosing to take place following completion of the remaining CMC activities and receipt of the necessary regulatory approvals. In parallel, the Company will continue to pursue strategic partnering opportunities for the future development and commercialization of HER-096."

New P2 trial • Parkinson's Disease

Herantis recently completed a pre-IND meeting with the U.S. Food and Drug Administration (FDA) to discuss the planned clinical development of HER-096 (GlobeNewswire) - "The FDA raised no concerns regarding the Company's chemistry, manufacturing and controls (CMC) information or preclinical data package and confirmed that, based on the current data package, Herantis would be in a position to activate U.S. clinical sites should an Investigational New Drug (IND) application be submitted. The FDA considered the Phase 2a trial design appropriate for the current stage of development and discussions also included the endpoint strategy for future clinical studies....The randomized, double-blind, placebo-controlled study is expected to enroll approximately 100 newly diagnosed Parkinson’s disease patients who are not receiving symptomatic medication across multiple sites in Europe."

FDA event • New P2a trial • Parkinson's Disease

Herantis Pharma Plc…announces a collaboration with Indivi, a Basel-based TechBio company focused on advancing precision medicine in neuroscience drug development, to integrate Indivi’s digital biomarker platform into Herantis’ upcoming Phase 2 proof-of-concept study of HER-096 in people living with Parkinson’s disease. (The Manila Times) - "Under the collaboration, Herantis Pharma will incorporate Indivi’s platform alongside conventional clinical assessments in its upcoming double-blind, placebo-controlled, randomized Phase 2 study of HER-096, with the aim of detecting early changes in motor and cognitive function following treatment."

Licensing / partnership • Parkinson's Disease

A PHASE 1B STUDY TO INVESTIGATE SAFETY, TOLERABILITY AND BIOMARKER RESPONSES OF REPEATED SUBCUTANEOUS DOSES OF HER-096 IN SUBJECTS WITH PARKINSON'S DISEASE (ADPD 2026) - "The primary endpoint of safety and tolerability was met. Plasma and CSF PK profiles (secondary endpoint) supports moving to Phase 2 with the current dose levels and dosing frequency. Exploratory biomarker data revealed changes in biomarkers related to e.g. modulation of proteostasis, indicating proof-of-biology."

Biomarker • Clinical • P1 data • CNS Disorders • Movement Disorders • Parkinson's Disease

Herantis Pharma to present HER-096 Phase 1b data at International Conference on Alzheimer’s & Parkinson’s Diseases (GlobeNewswire) - "Henri will present previously disclosed safety, tolerability, pharmacokinetic and biomarker data from 24 people living with PD who received 200 mg or 300 mg of HER-096 or placebo, repeated twice a week for four weeks. The results met all primary and secondary endpoints, demonstrating that HER-096 was safe and well tolerated. The data also showed that both dose levels of HER-096 achieved sufficient maximum concentration and total exposure in cerebrospinal fluid (CSF) to reach the expected pharmacologically active levels....Biomarker analyses from the Phase 1b trial showed clear clinical evidence of biological response to HER-096 exposure in people with Parkinson’s disease."

Biomarker • P1 data • Parkinson's Disease

Inside information: Herantis Pharma selected for Horizon 2025 grant of EUR 8.0 million for Phase 2 trial of HER-096 (The Manila Times) - "Funding to support the execution of a Phase 2 proof-of-concept trial of HER-096 in Parkinson’s disease, following completion of study preparations...Herantis intends to initiate the study as soon as the necessary preparations, including regulatory approvals and securing additional resources, are completed."

Financing • New P2 trial • Parkinson's Disease

Cerebral dopamine neurotrophic factor and its functional fragments induce calcium signal through sigma-1 receptor and protect neurons against glutamate-induced excitotoxicity. (PubMed, Biomed Pharmacother) - "CDNF and HER-096 reduced the glutamate-induced delayed Ca2+ deregulation and mitochondrial depolarisation which leads to significant protection against glutamate-induced excitotoxicity. Thus, the CDNF and HER-096 sigma-1 receptor mediated Ca2+ signal in astrocytes and neurons, from the ER, could modify the effects of high concentrations of glutamate that lead to neuroprotection."

Journal

Herantis Pharma - Phase 1b biomarker data show clear evidence of biological response to HER-096 in people with Parkinson's disease (GlobeNewswire) - "The Phase 1b trial consisted of 24 patients with Parkinson’s disease, who received twice-weekly dosing of either HER-096 or placebo over a four-week period....Biomarker data show that HER-096 modulates Parkinson’s disease-relevant pathways, consistent with preclinical data, and supporting further clinical development. HER-096 exposure was associated with changes across key disease-related pathways, including proteostasis, mitochondrial function, and neuroinflammation, aligned with the expected mechanism of action and indicating disease-modifying potential."

Biomarker • P1 data • Parkinson's Disease

Herantis Pharma Plc…announces the successful completion of a six-month preclinical Good Laboratory Practice (GLP) toxicology study for its lead clinical asset, HER-096 (GlobeNewswire) - "The study demonstrated a favorable safety and tolerability profile, well aligned with the previous pre-clinical and clinical data. These results provide further confidence in the compound’s suitability for long-term administration....The completion of the preclinical toxicology program also marks the final milestone of the EIC Accelerator Grant project....Herantis plans to initiate a Phase 2 clinical trial in 2026 to evaluate the efficacy, safety, and tolerability of HER-096 in people with Parkinson’s disease."

Financing • New P2 trial • Preclinical • Parkinson's Disease

High-capacity microfluidic compartmentalized cell cultures for studying axonal regrowth in sporadic ALS iPSC-derived motor neurons (Neuroscience 2025) - "In addition, the cell compatibility of the plate has been tested with several primary and iPSC-derived neuronal cultures.As an example of the utility of the co-culture plate, it was used to evaluate the effects of HER-096, a peptide drug developed based on the active site of cerebral dopamine neurotrophic factor (CDNF), on axonal regrowth post-axotomy in motor neuron cultures derived from sporadic ALS iPSCs. doi: 10.1021/acschemneuro.3c00409. PMID: 38150531; PMCID: PMC10797611."

Preclinical • CNS Disorders • Movement Disorders • Parkinson's Disease

A Phase 1b Study to Investigate Safety and Tolerability of Repeated Subcutaneous Doses of HER-096 in Subjects with Parkinson's Disease (MDS Congress 2025) - "Single ascending s.c. doses of HER-096 were safe and well tolerated in the previous Phase 1a study. Combined CSF PK data from the Phase 1a and 1b studies suggest the expected level of CSF exposure in humans at the tested dose levels, in line with available preclinical PK/PD data. Topline safety data and available biomarker data from the repeated dose part of the study will be reported at the meeting."

Clinical • P1 data • CNS Disorders • Movement Disorders • Parkinson's Disease

Herantis Pharma presents positive topline data for HER-096 in Phase 1b trial for people living with Parkinson’s disease (GlobeNewswire) - "Trial meets all primary and secondary endpoints....The clinical trial demonstrated that both repeated 200 mg and 300 mg doses of HER-096 are generally safe and well tolerated in Parkinson’s disease (PD) patients. Results from the clinical trial demonstrated a pharmacokinetic profile consistent with predictions from the single-dose studies in healthy volunteers....The full dataset, including exploratory biomarker data, is expected before the end of 2025....Herantis intends to advance HER-096 into a Phase 2 clinical trial during 2026..."

New P2 trial • P1 data • Parkinson's Disease

Clinical Study of HER-096 in Healthy Volunteer Subjects and Patients With Parkinson's Disease (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Herantis Pharma Plc. | Active, not recruiting ➔ Completed | Trial completion date: Dec 2025 ➔ Aug 2025

Trial completion • Trial completion date • CNS Disorders • Movement Disorders • Parkinson's Disease

Summary and outlook for 2025 (GlobeNewswire) - "The Company will simultaneously continue its partnership discussions and preparations for the Phase 2 study of HER-096."

New P2 trial • Parkinson's Disease

Last patient visit completed on schedule in Phase 1b clinical trial of HER-096 for Parkinson’s disease (GlobeNewswire) - "Patient visits are now complete in the final cohort of Phase 1b trial, consisting of Parkinson’s disease patients receiving 300 mg doses of HER-096 or placebo twice weekly over a four-week period....Topline Phase 1b results are expected within six-to-nine weeks....The full dataset, including biomarker data, is expected before the end of the year."

P1 data • Trial status • Parkinson's Disease

Clinical Study of HER-096 in Healthy Volunteer Subjects and Patients With Parkinson's Disease (clinicaltrials.gov) - P1 | N=40 | Active, not recruiting | Sponsor: Herantis Pharma Plc. | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Movement Disorders • Parkinson's Disease

Final patient cohort dosed in HER-096 Phase 1b clinical trial for Parkinson’s disease (Pf Media) - "Herantis Pharma Plc ('Herantis'), a company developing disease-modifying therapies for Parkinson’s disease, has announced the first patients have been dosed in the final cohort of its Phase 1b clinical trial evaluating the safety and tolerability of HER-096 in patients with Parkinson’s disease....Topline results are expected in September 2025."

Trial status • Parkinson's Disease

First patients dosed in final cohort of Phase 1b clinical trial of HER-096 for Parkinson’s disease (GlobeNewswire) - "Herantis Pharma Plc...today announced the first patients have been dosed in the final cohort of its Phase 1b clinical trial evaluating the safety and tolerability of HER-096 in patients with Parkinson’s disease....We remain focused on completing the final cohort of this Phase 1b trial and expect to report topline data in September 2025."

P1 data • Trial status • Parkinson's Disease

GRP78 INTERACTION MEDIATES THE NEUROPROTECTIVE EFFECTS OF CDNF AND HER -096 (ADPD 2025) - "HER-096 is a brain -penetrating peptidomimetic derived from the active site of human CDNF protein and is developed as a disease -modifying treatment for Parkinson's disease. UPR pathway is a key mediator of the neuroprotective activity of C -CDNF where interaction with GRP78 plays a central role. HER -096 is designed based on the GRP78 -binding interface and mimics the cytoprotective effects of CDNF."

CNS Disorders • Movement Disorders • Parkinson's Disease • HSPA5

Clinical Study of HER-096 in Healthy Volunteer Subjects and Patients with Parkinson's Disease (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Herantis Pharma Plc.

New P1 trial • CNS Disorders • Movement Disorders • Parkinson's Disease • CRP

Brain-penetrating neurotrophic factor mimetics: HER-096 as a disease-modifying therapy for Parkinson's disease. (PubMed, Neural Regen Res) - No abstract available

Journal • CNS Disorders • Movement Disorders • Parkinson's Disease

Herantis Pharma granted €3.6m to assess treatment for Parkinson’s disease (PharmaTimes) - "Herantis Pharma has been awarded €3.6m in funding from Parkinson’s UK’s Virtual Biotech programme and the Michael J. Fox Foundation to finance its early-stage clinical trial in Parkinson’s disease (PD) and its ongoing biomarker project. The phase 1b clinical trial is evaluating the tolerability and safety of HER-096 in PD patients and collecting exploratory biomarker data for future clinical trials."

Financing • CNS Disorders • Parkinson's Disease

EXPLORING THE MULTIPLE MECHANISMS UNDERLYING HER-096 NEUROPROTECTION AND REGENERATION (ADPD 2024) - "Aims: HER-096 is a brain-penetrating peptidomimetic derived from the active site of human CDNF protein and is developed as a disease-modifying treatment for Parkinson's disease. A multi-omics approach was employed to uncover the multimodal mechanism underlying the effects of HER-096 on functional recovery in chronic and acute degeneration. Our results suggest that HER-096 promotes functional recovery and regeneration of stressed neurons via multiple complementary ways."

CNS Disorders • Movement Disorders • Parkinson's Disease