HER-096 / Herantis - LARVOL DELTA

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

Herantis Pharma announces submission of a Clinical Trial Application (CTA) for a Phase 1 study for HER-096 (Market Screener) - "Herantis Pharma Plc...developing disease-modifying therapies for Parkinson's disease, announced it submitted a Clinical Trial Application (CTA) today to the Finnish Medicines Agency Fimea, the national competent authority for regulating pharmaceuticals. The Phase 1 study, which includes assessment of safety, tolerability, and blood-brain barrier penetration in healthy volunteers, will be carried out in Finland....'we look forward to the first HER-096 human dose in 1H 2023.'"

New P1 trial • CNS Disorders • Parkinson's Disease

Herantis publishes 1H Report for 2022 (Market Screener) - "Our near-term milestones for HER-096 are: Final results of the preclinical Blood-Brain-Barrier (BBB) penetration studies in several animal species (targeted H2/2022); Preclinical safety data (GLP studies) (targeted H2/2022); Submission of CTA (targeted H2/2022); Approval of the CTA (targeted H1/2023); First HER-096 human dose in Phase 1 study (targeted H1/2023); and Demonstration of HER-096 BBB penetration and safety in human (targeted H2/2023)."

New P1 trial • Preclinical • CNS Disorders • Parkinson's Disease

Preliminary results of Herantis Pharma Plc's fully subscribed rights issue (Market Screener) - "Herantis Pharma Plc...announced on 3 May 2022 that the Board of Directors of Herantis had decided to offer Herantis' shareholders up to 4,831,426 new shares...in a rights issue on the basis of shareholders' pre-emptive subscription rights in the same proportion as they already hold shares in the Company and secondarily by other shareholders or by other persons (the 'Offering'). The subscription period for the Offering ended on 24 May 2022 in Sweden and on 27 May 2022 in Finland and according to the preliminary result, Herantis will receive gross proceeds of approximately EUR 7.25 million, from the Offering....'We will use the net proceeds from this Offering to obtain regulatory approval and perform the first in-human study with the Herantis' lead product candidate HER-096 that is planned to start in 2023.'"

Financing • CNS Disorders • Parkinson's Disease

Herantis Pharma Announces Successful HER-096 Initial Results with Blood-Brain Barrier Penetration in Dogs (Market Screener) - "Herantis Pharma Plc...today announced initial results of HER-096 blood-brain barrier (BBB) penetration in dogs. The results demonstrate that following a single subcutaneous administration of HER-096, the concentration of HER-096 measured from the cerebrospinal fluid (CSF) is within the pharmacologically active level. This result is aligned with previous data obtained from rats. These data show that subcutaneous administration allows effective brain distribution both in small and large animals and support this route of administration to be used for HER-096 in first-in-human clinical study. Herantis aims to report the final results of the preclinical BBB-penetration studies in animals as well as the preclinical GLP safety data during the second half of 2022. Herantis' plan is to initiate the first-in-human study with HER-096 in 2023."

New trial • Preclinical • CNS Disorders • Parkinson's Disease

Herantis Pharma Plc is contemplating carrying out a directed share issue and a rights issue (Market Screener) - "Herantis Pharma Plc...is contemplating two separate share issues with a preliminary aggregate amount of up to EUR 8.7 million. The net proceeds from the share issues will be used for taking Herantis' lead asset, HER-096 into a Phase 1 study and towards proving penetration of the blood brain barrier and safety in human in H2 2023."

Financing • New P1 trial • CNS Disorders • Parkinson's Disease

Herantis Pharma Oyj : Announces Successful HER-096 Initial Results with Nanoform Technology (Market Screener) - "Herantis Pharma Plc...announced: Results of proof-of-concept study demonstrating successful nanoforming of HER-096 into nanoparticles; Further exploration the applicability of Nanoform's technology in the development of an oral dosage form based on HER-096 nanoparticles....Subcutaneous administration will be used in Herantis' HER-096 first-in-human clinical study that is expected to commence in 2023."

New trial • Preclinical • CNS Disorders • Parkinson's Disease

"CEO transition; Herantis to focus on HER-096 https://t.co/KoqqMIOD23" (@CisionNews)

Herantis Marks A Successful 2021; An Ambitious and Promising 2022 Ahead to Advance Robust CNS Pipeline (Market Screener) - "Herantis Pharma Plc...gives a 2021 year end summary of the progress of the company and the plans for 2022....Successful completion of HER-096 non-clinical program to support the first-in-human study...Filing for regulatory approval to start a first-in-human study with HER-096...Defining the patient population for further clinical development...Confirmation of feasibility of rhCDNF brain distribution following intranasal spray administration"

New trial • Preclinical • CNS Disorders • Parkinson's Disease