Herantis Pharma Plc, Press release, 11 November 2024 at 17:05 EET

Herantis Pharma has successfully completed the Part 1 of the Phase 1b clinical trial

• In Part 1, the investigational HER-096 was administered as a single 300 mg subcutaneous dose to 8 healthy volunteer subjects.
• Pharmacokinetic profiles of HER-096 in both blood and cerebrospinal fluid were as expected and aligned with previous clinical data.
• Safety profile was as expected and aligned with the previous clinical data.
• The recruitment of Parkinson’s patients to Part 2 of the Phase 1b trial has started.

Herantis Pharma Plc ("Herantis"), a company developing disease-modifying therapies for Parkinson’s disease, is pleased to announce that the Part 1 of the Phase 1b clinical trial is successfully completed. The data and safety monitoring board (DSMB) has decided that the trial can continue to Part 2 with up to 28 patients with Parkinson’s disease.

“We are very happy that the pharmacokinetic data of the Part 1 confirms our assumptions related to HER-096 exposure in the cerebrospinal fluid giving us the necessary information about drug administration for designing a Phase 2 clinical trial,” commented CEO Antti Vuolanto. “We look forward to starting the Part 2 of the Phase 1b trial, where Parkinson’s patients will receive multiple doses of HER-096.”

The Phase 1b clinical trial has two parts:

• In Part 1 (which is now finalized), 8 healthy volunteer subjects were administered with a single 300 mg subcutaneous dose for assessment of pharmacokinetic properties and safety of HER-096.
• In Part 2, up to 28 patients with Parkinson’s disease will be dosed for 4 weeks, 2 doses per week, with either 200 mg or 300 mg HER-096, or placebo to study the safety, tolerability and pharmacokinetics of repeated subcutaneous doses of HER-096. The aim is also to evaluate selected biomarkers, and to discover and identify novel treatment response biomarkers in Parkinson’s patients.

The study takes place in Turku, Finland conducted by the contract research organization Clinical Research Services Turku – CRST Oy.

More information about participation into the study 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, the regulation of which is essential in restoring the cell protein balance (proteostasis) and preventing the processes leading to, e.g., cytotoxic protein aggregation and neuronal cell death in the brain. In addition, HER-096 alleviates inflammation in the affected brain area. Thanks to its multimodal mechanism of action, Herantis’ 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

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 are 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.