ODM-104 / Orion Corp - LARVOL DELTA

BRIAN: Blood-Brain Barrier Penetration of Therapeutic Agents in Human (clinicaltrials.gov) - P1; N=4; Completed; Sponsor: Orion Corporation, Orion Pharma; Recruiting ➔ Completed

Trial completion • Alzheimer's Disease • CNS Disorders • Ventriculomegaly

BRIAN: Blood-Brain Barrier Penetration of Therapeutic Agents in Human (clinicaltrials.gov) - P1; N=6; Recruiting; Sponsor: Orion Corporation, Orion Pharma; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Alzheimer's Disease • CNS Disorders • Ventriculomegaly

BRIAN: Blood-Brain Barrier Penetration of Therapeutic Agents in Human (clinicaltrials.gov) - P1; N=6; Not yet recruiting; Sponsor: Orion Corporation, Orion Pharma

Clinical • New P1 trial • Alzheimer's Disease • CNS Disorders • Ventriculomegaly

Pharmacokinetic of Levodopa Study in Healthy Males (clinicaltrials.gov) - P1; N=20; Completed; Sponsor: Orion Corporation, Orion Pharma; Active, not recruiting ➔ Completed

Trial completion • Biosimilar • CNS Disorders • Gene Therapies • Parkinson's Disease

Orion Group financial statement release for 2014 (Orion Press Release) - "Net sales of Orion's Stalevo® (carbidopa, levodopa and entacapone) and Comtess®/Comtan® (entacapone) Parkinson's drugs were down by 18% at EUR 169 (207) million, which was 18% (22%) of the Pharmaceuticals business's net sales."; P1, N=54; NOCIFIM (NCT01840423); P1, N=67; NOCOS (NCT01688089); Sponsor: Orion Corporation; "Orion has completed Phase I clinical safety trials with new COMT inhibitors (ODM-103 and ODM-104). Based on the results obtained, Orion has decided to select ODM-104 for further development and is preparing to commence Phase II clinical trials with the molecule."

Anticipated new P2 trial • Anticipated phase shift • Pipeline update • Sales • Trial completion • Parkinson's Disease

COMDOS1: Dose-finding Pharmacokinetic Study in Healthy Males (clinicaltrials.gov) - P1; N=56; Completed; Sponsor: Orion Corporation, Orion Pharma; Recruiting ➔ Completed

Trial completion • Biosimilar

Tolerability, Pharmacokinetics and Pharmacodynamic Effects of ODM-104 a Novel Catechol-O-Methyltransferase Inhibitor, after Escalating Repeated Doses in Healthy Subjects (EAN 2018) - "ODM-104 produced significantly higher levodopa exposure than entacapone. Disclosure The study was sponsored by Orion Pharma."

Clinical • PK/PD data • CNS Disorders • Parkinson's Disease

NOCOFPK2-Pharmacokinetic Study in Healthy Volunteers (clinicaltrials.gov) - P1; N=12; Recruiting; Sponsor: Orion Corporation, Orion Pharma

New P1 trial • Biosimilar • Parkinson's Disease