Herantis Pharma has submitted a Clinical Trial Application (CTA) for a Phase 1b clinical trial of HER-096

May 20, 202407:00 UTC

Press release

Herantis Pharma Plc, Press release, 20 May 2024 at 10:00 a.m EEST

The primary objective is to evaluate the safety and tolerability of subcutaneously (s.c.) administered HER-096 in healthy volunteer subjects and in patients with Parkinson’s disease (PD).

Herantis Pharma Plc (“Herantis”), a clinical-stage biotechnology company developing disease-modifying therapies for Parkinson’s disease is pleased to announce that it has submitted a Clinical Trial Application (CTA) to the Competent Authority for obtaining authorization to conduct a Phase 1b clinical trial of HER-096 in Finland.

“We look forward to test repeated subcutaneous dosing of HER-096 in Parkinson’s disease patients in the Phase 1b clinical trial, pending regulatory approval. This trial will be an important development milestone for being ready to start a Phase 2 clinical trial.”, said Antti Vuolanto, the CEO of Herantis Pharma. “The promising results of the Phase 1a trial conducted in 2023, where one subcutaneous dose of HER-096 was safe and well tolerated, and efficiently penetrated the blood-brain barrier in healthy volunteers, enabled us to proceed into Phase 1b trial preparations.”

About Phase 1b clinical trial

The primary aim of this clinical trial is to show that repeated subcutaneous doses of HER-096 are safe and well-tolerated in patients with Parkinson’s disease. The trial also aims to evaluate selected biomarkers, discover and identify novel biomarkers, and to evaluate pharmacokinetic profile supporting dose selection for Phase 2 clinical trial. The Phase 1b clinical trial will enroll up to 12 healthy volunteer subjects and up to 24 patients with Parkinson’s disease.

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 Oy, Finland: +358 9 25 380 225

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 Phase 1a clinical trial demonstrated a good safety and tolerability profile, and efficient blood-brain barrier penetration of subcutaneously administered HER-096 in humans. The shares of Herantis are listed on the Nasdaq First North Growth Market Finland.

Company website: www.herantis.com

Forward-looking statements

This company 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.