Herantis Pharma Plc: First healthy volunteers dosed in the part 2 of the HER-096 Phase 1a clinical study
2023-08-22 · Herantis Pharma Plc. · original herantis.com ↗
Herantis Pharma Plc | Press Release | August 22, 2023 at 10:30:00 EEST Herantis Pharma Plc Press release, 22 August 2023 at 10:30 a.m. EEST Herantis Pharma Plc (“Herantis”), a clinical-stage biotechnology company developing disease modifying therapies for Parkinson’s disease, announces that the dosing of the healthy volunteers in part 2 of the Phase 1a clinical study has been started based on decision from the Data and Safety Monitoring Board. Top-line data of the Phase 1a clinical study is expected in Q4 2023. About the HER-096 Phase 1a clinical study: Phase 1a is a randomized, double-blinded, placebo-controlled, safety, tolerability, and pharmacokinetic study of subcutaneous single ascending doses of HER-096. In part 1 of the study, HER-096 or placebo was administered to young healthy volunteers and in the now started part 2 of the study, 12-16 elderly healthy volunteers, both males and females, will be administered with a single dose of HER-096 to evaluate the blood-brain-barrier penetration of HER-096. In total, the study aims to recruit around 60 healthy volunteer subjects. The study takes place in Turku, Finland conducted by the contract research organization CRST. Link to ClinicalTrials.gov for more information about the study: https://www.clinicaltrials.gov/study/NCT05915247?term=herantis&rank=1 More information about participation into the study can be found on the website (only in Finnish): https://osallistulaaketutkimukseen.fi/kliininen-laaketutkimus-50-75-vuotiaille-c739/ 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. Contacts For more information, please contact: Julie Silber/Gabriela Urquilla Tel: +46 (0)7 93 486 277/+46 (0)72-396 72 19 Email: [email protected] Certified Advisor: UB Securities Ltd, Finland: +358 9 25 380 225 About Us 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 parent CDNF protein. It combines the compelling mechanism of action of the CDNF protein with the convenience of subcutaneous administration. The ongoing Phase 1a clinical study will assess safety, tolerability, and blood-brain barrier penetration of subcutaneously administered HER-096. Top-line data is expected by the end of 2023. The shares of Herantis are listed on the Nasdaq First North Growth Market Finland. Company website: www.herantis.com Attachments ENG Herantis Pharma Plc Part 2 First Dosing
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