Herantis reports positive FDA feedback and finalizes Phase 2a study design for HER-096

• FDA considered the planned HER-096 Phase 2a study design appropriate
• Study design finalized; approximately 100 patients to be enrolled
• More than 50% of Phase 2 funding secured or identified
  
  

Espoo, Finland, 2 June 2026: Herantis Pharma Plc (“Herantis”), a clinical-stage company developing disease-modifying therapies to stop the progression of Parkinson’s disease, today provides an update on preparations for the Phase 2a proof-of-concept efficacy study of HER-096, its lead candidate for the treatment of Parkinson's disease, ahead of its webcast being hosted later today at 13.00 EEST (12:00 CEST).

Herantis recently completed a pre-IND meeting with the U.S. Food and Drug Administration (FDA) to discuss the planned clinical development of HER-096. The FDA raised no concerns regarding the Company's chemistry, manufacturing and controls (CMC) information or preclinical data package and confirmed that, based on the current data package, Herantis would be in a position to activate U.S. clinical sites should an Investigational New Drug (IND) application be submitted. The FDA considered the Phase 2a trial design appropriate for the current stage of development and discussions also included the endpoint strategy for future clinical studies.

The Phase 2a study is designed to evaluate the efficacy, safety and tolerability of HER-096 in patients with early-stage Parkinson's disease and is expected to provide the first evidence of its potential to deliver meaningful clinical benefit in patients. The randomized, double-blind, placebo-controlled study is expected to enroll approximately 100 newly diagnosed Parkinson’s disease patients who are not receiving symptomatic medication across multiple sites in Europe. Patients will receive twice-weekly subcutaneous dosing of HER-096 or placebo for six months, followed by a six-month open-label extension. The study will use a Digital Motor Score (DMS) as its primary endpoint, complemented by established clinical assessments, imaging and biomarker analyses. The integration of Indivi's digital biomarker platform is intended to provide objective and continuous assessments of disease progression and treatment response.

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