HER-096 / Herantis - LARVOL DELTA

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

A PHASE 1A FIRST-IN-HUMAN CLINICAL TRIAL OF HER-096, A SUBCUTANEOUSLY ADMINISTERED CDNF-DERIVED PEPTIDOMIMETIC (ADPD 2024) - "Preliminary assessments suggest a good safety profile for single ascending subcutaneous doses of HER-096. Full data analysis will be completed after database lock by November 2023 and the results will be reported in the AD/PD 2024 conference presentation."

Clinical • P1 data

HER-096 is a CDNF-derived brain-penetrating peptidomimetic that protects dopaminergic neurons in a mouse synucleinopathy model of Parkinson's disease. (PubMed, Cell Chem Biol) - "Subcutaneously administered HER-096 modulated UPR pathway activity, protected dopamine neurons, and reduced α-synuclein aggregates and neuroinflammation in substantia nigra of aged mice with synucleinopathy. Peptidomimetic HER-096 is a candidate for development of a disease-modifying therapy for Parkinson's disease with a patient-friendly route of administration."

Journal • Preclinical • CNS Disorders • Developmental Disorders • Inflammation • Movement Disorders • Parkinson's Disease

Single Ascending Doses of HER-096 in Healthy Subjects (clinicaltrials.gov) - P1 | N=60 | Completed | Sponsor: Herantis Pharma Plc. | Recruiting ➔ Completed

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

Herantis Pharma Plc Announces Start of Recruitment of Healthy Volunteers for Part 2 of the Ongoing Phase 1a Clinical Study of HER-096 (Market Screener) - "Herantis Pharma Plc is now starting recruiting healthy volunteers for part 2 of the ongoing Phase 1a clinical study of HER-096. In part 2, 12-16 older and elderly healthy volunteers will be administered with a single dose of HER-096 to evaluate the blood-brain-barrier penetration of HER-096 in addition the safety and tolerability....The study is a randomized, double-blinded, placebo-controlled, safety, tolerability, and pharmacokinetic study of subcutaneous single ascending doses of HER-096. The study aims to recruit around 60 healthy volunteer subjects. The study takes place in Turku, Finland conducted by the contract research organization, CRST."

Trial status • CNS Disorders • Parkinson's Disease

Single Ascending Doses of HER-096 in Healthy Subjects (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Herantis Pharma Plc.

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

Herantis Pharma Oyj : has signed European Innovation Council (EIC) Accelerator grant agreement (Market Screener) - "Herantis will receive €2.5 million grant funding and is eligible for up to €15 million in direct equity investments from the EIC Fund....The two-year grant project, named ReTreatPD, will focus on preparations towards a Phase 2 clinical study with HER-096 in Parkinson's disease including development of biomarkers for monitoring target engagement and treatment response to HER-096. In addition to the grant, Herantis is eligible to negotiate up to €15 million in direct equity investments from EIC Fund."

Financing • CNS Disorders • Parkinson's Disease

Herantis Pharma announces first healthy volunteer dosed in the Phase 1a clinical study for the Parkinson’s disease drug candidate, HER-096 (Herantis Pharma Press Release) - "The Phase 1a clinical study will assess safety, tolerability, and blood-brain barrier penetration of subcutaneously administered HER-096. Herantis Pharma Plc...is pleased to announce the dosing of the first healthy volunteer in the Phase 1a clinical study for HER-096....The study takes place in Turku, Finland conducted by the contract research organization, CRST."

Trial status • CNS Disorders • Parkinson's Disease

Herantis Pharma Shares Surge on Approval of Clinical Trial Application For Parkison's Disease Treatment (Market Screener) - "Herantis Pharma...said Monday its clinical trial application for its Parkinson's disease treatment was approved by the Finnish Medicines Agency, Fimea and the ethics committee. The biotech company will conduct the phase 1 study for HER-096 in Finland. Shares of Herantis Pharma rose about 16% on Monday afternoon."

New P1 trial • Stock price • CNS Disorders • Parkinson's Disease

HER-096 IS A NOVEL BRAIN-PENETRATING PEPTIDOMIMETIC THAT PROMOTES PROTEOSTASIS AND REDUCES NEUROINFLAMMATION IN AGED MOUSE MODEL OF SYNUCLEINOPATHY (ADPD 2023) - "Aims: To develop a next generat ion, brain -penetrating compound based on unconventional neurotrophic factor CDNF. Intraputamenal CDNF infusion has previously been tested in a Phase 1 study in moderately advanced Parkinson's disease (PD). A more patient -friendl y route of administration will support further development of a disease - modifying therapy for PD and allow access to earlier stage patients. We conclude that HER -096, a CDNF -derived peptidomimetic, is a novel candidate for disease -modification in Parkinson 's disease."

Preclinical • CNS Disorders • Developmental Disorders • Immunology • Inflammation • Movement Disorders • Parkinson's Disease • Targeted Protein Degradation

Herantis Pharma selected for European Innovation Council (EIC) grant of €2.5 million (Market Screener) - "Herantis Pharma Plc...announced today that it has been invited to negotiate a grant agreement with EIC. This grant will fund the further development of Herantis' lead product HER-096 for Parkinson's disease. Herantis' application successfully passed the EIC Accelerator three-stage evaluation process; in the final stage EIC Jury of independent experts made a recommendation of funding of Herantis' proposal. Herantis will provide additional information following the conclusion of negotiations with EIC."

Financing • CNS Disorders • Parkinson's Disease