First patients dosed in final cohort of Phase 1b clinical trial of HER-096 for Parkinson’s disease

Herantis Pharma Plc – Press release

First patients dosed in final cohort of Phase 1b clinical trial of HER-096 for Parkinson’s disease

• HER-096 is a first-in-class agent in development for the treatment of Parkinson’s disease with disease modifying potential and convenient subcutaneous administration
• Successful completion of the first patient cohort in Part 2 of the trial and approval to proceed from the Data and Safety Monitoring Board
• Primary objective is to assess the safety, tolerability and pharmacokinetics of repeated subcutaneous doses of HER-096; the trial will also evaluate selected biomarkers, discover and identify novel treatment response biomarkers and monitor symptoms associated with Parkinson’s disease
• Topline data from Phase 1b trial is expected in September 2025
• Trial funded by the Michael J. Fox Foundation for Parkinson’s Research (MJFF) and Parkinson’s UK
  
  

Espoo, Finland, 13 May 2025: Herantis Pharma Plc ("Herantis"), a company developing disease-modifying therapies for Parkinson’s disease, 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.

Commenting on the study Antti Vuolanto, CEO of Herantis Pharma said: “Parkinson’s disease is a life altering condition, and there is an urgent need for new treatments that can halt or slow its progression. We are highly encouraged by the potential of HER-096. Its disease-modifying properties combined with its ability to cross the blood-brain barrier makes it a compelling candidate to become a transformative therapy for Parkinson’s that addresses the underlying disease, not just the symptoms. We remain focused on completing the final cohort of this Phase 1b trial and expect to report topline data in September 2025.”

Parkinson’s disease is a devastating neurological condition affecting around 10 million people worldwide, for which there is currently no cure. Existing treatments only address the symptoms and are often associated with significant side effects.

HER-096 is a first-in-class synthetic peptidomimetic designed to mimic the activity of cerebral dopamine neurotropic factor (CDNF) protein, with the capability of effectively crossing the blood-brain barrier allowing for convenient subcutaneous administration. With a multi-modal mechanism of action, HER-096 has the potential to protect against the neuronal degeneration and cell death that cause the symptoms of Parkinson’s disease.

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 phase were announced on 28 January 2025 here

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. Based on a review of the data, the Data and Safety Monitoring Board (DSMB) recommended proceeding to the final cohort. In the final cohort, patients will receive 300 mg doses of HER-096 or placebo twice weekly over a four-week period.

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 will also evaluate selected biomarkers and aims to identify novel treatment-response biomarkers in patients with Parkinson’s disease. Symptom progression will be monitored using both Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and with a wearable recording device.

Topline results are expected in September 2025.

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 HER-096 in healthy volunteers.

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

https://osallistulaaketutkimukseen.fi/parkinsonin-tauti-laaketutkimus-potilaille_c880/

The trial is registered at ClinicalTrials.gov here: https://clinicaltrials.gov/study/NCT06659562?intr=her-096&rank=1

About HER-096

HER-096 is an engineered peptidomimetic molecule designed to mimic the activity of CDNF, a protein that promotes cell survival and functional recovery of neurons. HER-096 modulates the Unfolded Protein Response (UPR) pathway, which plays a critical role in restoring the cell protein balance (proteostasis) and preventing the processes leading to cytotoxic protein aggregation and neuronal cell death in the brain. In addition, HER-096 reduces inflammation in the affected brain area and can effectively pass the blood-brain barrier enabling convenient subcutaneous administration. With its multimodal mechanism of action, HER-096 has the potential to stop the progression of Parkinson’s disease and significantly improve patients’ quality of life.

For more information, please contact:

Tone Kvåle, CFO
Tel: +47 915 19576
Email: ir@herantis.com

ICR Healthcare

Mary-Jane Elliott, Sarah Elton-Farr, Stephanie Cuthbert
Tel: +44 20 3709 5700
Email: herantispharma@icrhealthcare.com

Certified Advisor:

UB Corporate Finance Ltd
Tel.: +358 9 25 380 225
E-mail: ubcf@unitedbankers.fi

About Herantis Pharma Plc

Herantis Pharma Plc is a clinical-stage biotechnology company developing disease modifying therapies for Parkinson’s disease. Herantis’ lead product HER-096, is an advanced small synthetic chemical peptidomimetic molecule developed based on the active site of the CDNF protein. It combines the compelling mechanism of action of CDNF with the convenience of subcutaneous administration. The primary aim of the ongoing Phase 1b clinical trial is to show that repeated subcutaneous doses of HER-096 are safe and well-tolerated in patients with Parkinson’s disease. The Phase 1a clinical trial demonstrated a good safety and tolerability profile, and efficient blood-brain barrier penetration of subcutaneously administered HER-096 in healthy volunteers.

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

Company website: www.herantis.com

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.