Herantis Pharma announces submission of a Clinical Trial Application (CTA) for a Phase 1 study for HER-096
Herantis Pharma Plc, Press release, 19 December 2022 at 2:15 p.m. EET
The purpose of the Phase 1 study is to demonstrate safety, tolerability, and blood-brain barrier penetration of HER-096 in human.
Herantis Pharma Plc ("Herantis") 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.
“Filing of the CTA demonstrates the substantial progress we have made in advancing the HER-096 program during this year including conducting the GLP preclinical safety studies and GMP-manufacturing”, said Antti Vuolanto, the CEO of Herantis Pharma. “The compelling preclinical data supports the potential of HER-096 to be a disease-modifying therapy for Parkinson’s disease with a unique mechanism of action. Pending decision from Fimea, we look forward to the first HER-096 human dose in 1H 2023.”
About HER-096
HER-096 is a peptidomimetic molecule designed to retain the biological activity of the neuroprotective CDNF protein. HER-096 has demonstrated to have a multimodal mechanism of action mimicking CDNF and to improve functional recovery of damaged neurons in preclinical models. Importantly, HER-096 has been shown to readily penetrate the blood brain barrier in preclinical studies allowing convenient subcutaneous dosing. 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:
Julie Silber/Gabriela Urquilla
Tel: +46 (0)7 93 486 277/+46 (0)72-396 72 19
Email: ir@herantis.com
Certified Advisor: UB Securities Ltd, Finland: +358 9 25 380 225, Sweden: +358 40 5161400
Company website: www.herantis.com
About Herantis Pharma Plc
Herantis Pharma Plc is an innovative biotech 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 parent CDNF protein. It combines the compelling mechanism of action of the CDNF protein with the convenience of subcutaneous administration.
The shares of Herantis are listed on the Nasdaq First North Growth Market Finland and Nasdaq First North Growth Market Sweden.
For more information, please visit www.herantis.com.
Forward-looking statements
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