Last patient visit completed on schedule in Phase 1b clinical trial of HER-096 for Parkinson’s disease

• 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
• Primary objective is to assess the safety, tolerability and pharmacokinetics of repeated subcutaneous doses of HER-096; the trial will also evaluate selected biomarkers, and aims to identify novel treatment response biomarkers and monitor symptoms associated with Parkinson’s disease
• Topline Phase 1b results are expected within six-to-nine weeks, following data unblinding, analysis and interpretation
• The full dataset, including biomarker data, is expected before the end of the year
• Trial is funded by the Michael J. Fox Foundation for Parkinson’s Research (MJFF) and Parkinson’s UK
  
  
  
  

Espoo, Finland, 14 August 2025: Herantis Pharma Plc ("Herantis"), a clinical-stage company developing disease-modifying therapies to stop Parkinson’s disease, announces that the last patient visit has now been completed on schedule in the Phase 1b clinical trial evaluating the safety and tolerability of HER-096 in patients with Parkinson’s disease.

Antti Vuolanto, CEO of Herantis Pharma, said: “We are pleased to have completed all patient dosing and follow-up visits in our Phase 1b study of HER-096. With this milestone reached, we will now concentrate on completing the data analysis and interpretation. We look forward to updating the market with the topline data as we explore HER-096’s potential to become the first disease-modifying and neurorestorative treatment for Parkinson’s disease.”

Herantis Pharma is developing HER-096, a first-in-class small peptide molecule, for the treatment of Parkinson’s disease. HER-096 is based on the active site of and designed to mimic the activity of cerebral dopamine neurotrophic factor (CDNF), a protein known to promote neuronal cell survival and functional recovery.

Parkinson’s disease is a chronic, progressive and debilitating neurological disorder affecting over 10 million people worldwide. There are no approved disease-modifying therapies capable of stopping or slowing its progression. Existing treatments only address the symptoms, offering limited and often inconsistent relief, and are frequently associated with significant side effects.

About the Phase 1b study

The Phase 1b clinical study consists of two parts. In Part 1, eight healthy volunteers received a single 300 mg subcutaneous dose of HER-096 to assess its safety and pharmacokinetic properties. Encouraging pharmacokinetic data from this part of the study were announced on 28 January 2025 .

Part 2 is a randomized, double-blind, placebo-controlled part of the trial in patients with Parkinson’s disease, divided into two cohorts. In the first cohort, 12 patients were dosed twice weekly over a four-week period. Of these, eight patients received 200 mg of HER-096 and four received placebo. In the second cohort, patients received 300 mg doses of HER-096 or placebo twice weekly over a four-week period, similarly to the first cohort.

The primary objective of the Phase 1b trial is to assess the safety, tolerability and pharmacokinetics of repeated subcutaneous doses of HER-096. Part 2 of the trial will also evaluate selected biomarkers and aims to identify novel treatment-response biomarkers in patients with Parkinson’s disease. Symptoms will be monitored using both Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and with a wearable monitoring device.

This trial is funded by The Michael J. Fox Foundation for Parkinson’s Research (MJFF) and Parkinson’s UK. It is being conducted in Turku and Helsinki, Finland by the contract research organization Clinical Research Services Turku – CRST Oy.

The Phase 1b trial builds on positive results from the Phase 1a trial, which demonstrated a good safety and tolerability profile, along with effective blood-brain barrier penetration of subcutaneously administered single dose of HER-096 in healthy volunteers.

More information about the trial can be found on the website:  

The trial is registered at ClinicalTrials.gov here: 

The trial is registered at EU Clinical Trials here:

About HER-096

Herantis Pharma is developing HER-096, a first-in-class drug candidate with the potential to stop the progression of Parkinson’s disease, repair striatal damage and significantly improve both an individual’s symptoms and quality of life.

HER-096 is a small peptide molecule based on the active site of and designed to mimic the activity of cerebral dopamine neurotrophic factor (CDNF), a protein known to promote neuronal cell survival and functional recovery.

HER-096’s multimodal mechanism of action targets key drivers of neurodegeneration in PD by modulation of the Unfolded Protein Response (UPR) pathway, reducing aggregation of the neurotoxic protein α-synuclein, and modulation of neuroinflammation. Combined with its demonstrated brain penetration, this enables HER-096 to protect dopamine neurons from further degeneration and supports their functional restoration.

For more information, please contact:

Herantis Pharma:

Tone Kvåle, CFO

Tel:

Email: 

:

Mary-Jane Elliott, Sarah Elton-Farr, Stephanie Cuthbert

Tel: 0

Email:

Certified Advisor:

UB Corporate Finance Ltd

Tel.: 25

E-mail: 

About Herantis Pharma Plc

Herantis Pharma Plc is a clinical-stage biotechnology company developing disease-modifying therapies for Parkinson’s disease. The Company’s lead product, HER-096, is a first-in-class small peptide that combines the neuroprotective mechanism of cerebral dopamine neurotrophic factor (CDNF), with the convenience of subcutaneous administration. HER-096 is currently being evaluated in a Phase 1b clinical trial to assess the safety and tolerability of repeated subcutaneous dosing in patients with Parkinson’s disease. The study builds on positive Phase 1a results, where HER-096 demonstrated a favourable safety and tolerability profile, and effective brain penetration in healthy volunteers.

Herantis is listed on the Nasdaq First North Growth Market Finland.

Company website: 

Forward-looking statements

This release includes forward-looking statements which are not historical facts but statements regarding future expectations instead. These forward-looking statements include without limitation, those regarding Herantis’ future financial position and results of operations, the Company’s strategy, objectives, future developments in the markets in which the Company participates or is seeking to participate or anticipated regulatory changes in the markets in which the Company operates or intends to operate. In some cases, forward-looking statements can be identified by terminology such as “aim,” “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forecast,” “guidance,” “intend,” “may,” “plan,” “potential,” “predict,” “projected,” “should” or “will” or the negative of such terms or other comparable terminology. By their nature, forward-looking statements involve known and unknown risks, uncertainties and other factors because they relate to events and depend on circumstances that may or may not occur in the future. Forward-looking statements are not guarantees of future performance and are based on numerous assumptions. The Company’s actual results of operations, including the Company’s financial condition and liquidity and the development of the industry in which the Company operates, may differ materially from (and be more negative than) those made in, or suggested by, the forward-looking statements contained in this company release. Factors, including risks and uncertainties that could cause these differences include, but are not limited to risks associated with implementation of Herantis’ strategy, risks and uncertainties associated with the development and/or approval of Herantis’ drug candidates, ongoing and future clinical trials and expected trial results, the ability to commercialize drug candidates, technology changes and new products in Herantis’ potential market and industry, Herantis’ freedom to operate in respect of the products it develops (which freedom may be limited, e.g., by competitors’ patents), the ability to develop new products and enhance existing products, the impact of competition, changes in general economy and industry conditions, and legislative, regulatory and political factors. In addition, even if Herantis’ historical results of operations, including the Company’s financial condition and liquidity and the development of the industry in which the Company operates, are consistent with the forward-looking statements contained in this company release, those results or developments may not be indicative of results or developments in subsequent periods.