UCB7853 / UCB, Novartis - LARVOL DELTA

A PRECLINICAL EVALUATION OF UCB7853, AN ANTI ALPHA -SYNUCLEIN ANTIBODY IN CLINICAL DEVELOPMENT FOR PARKINSON'S DISEASE (ADPD 2025) - "Collectively, these preclinical findings support the clinical development of UCB7853 as a treatment for people with PD."

Preclinical • CNS Disorders • Movement Disorders • Parkinson's Disease

PHASE I STUDY RESULTS: UCB7853 SAFETY, TOLERABILITY AND PHARMACOKINETICS IN HEALTHY PARTICIPANTS (SINGLE -ASCENDING DOSE) AND PEOPLE WITH PD (MULTIPLE -ASCENDING DOSES) (ADPD 2025) - "UCB7853 was well tolerated with an acceptable safety profile in healthy participants and PwP. These results support further clinical development of UCB7853 in PD."

Clinical • P1 data • PK/PD data • CNS Disorders • Movement Disorders • Parkinson's Disease

A Safety and Pharmacokinetics Study of UCB7853 in Healthy Study Participants and Study Participants With Parkinson's Disease (PD) (clinicaltrials.gov) - P1 | N=57 | Completed | Sponsor: UCB Biopharma SRL | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Movement Disorders • Parkinson's Disease

A Safety and Pharmacokinetics Study of UCB7853 in Healthy Study Participants and Study Participants With Parkinson's Disease (PD) (clinicaltrials.gov) - P1 | N=57 | Active, not recruiting | Sponsor: UCB Biopharma SRL | Recruiting ➔ Active, not recruiting | Trial completion date: Nov 2023 ➔ Jul 2023 | Trial primary completion date: Nov 2023 ➔ Jul 2023

Enrollment closed • Trial completion date • Trial primary completion date • CNS Disorders • Movement Disorders • Parkinson's Disease

UCB Announces Global Partnership To Bring Disease-Modifying Therapies To People Living With Parkinson's Disease (PRNewswire) - "UCB today announced that it has entered into a global co-development and co-commercialization agreement with Novartis covering UCB0599...currently in Phase 2 clinical development, and upon completion of the ongoing Phase 1 program, an opt-in to co-develop UCB7853, an anti-alpha-synuclein antibody, both in Parkinson's Disease (PD)....UCB will receive an upfront payment of US$150 million and is eligible to receive further potential payments with a total consideration approaching US$1.5 billion upon receipt of certain regulatory approvals and satisfying certain development and sales related milestones. If approved, commercial responsibilities will be split, with UCB being the marketing authorization holder and commercial lead in Europe and Japan, and Novartis in the US and all other territories."

Licensing / partnership • CNS Disorders • Parkinson's Disease

A Safety and Pharmacokinetics Study of UCB7853 in Healthy Study Participants and Study Participants With Parkinson's Disease (PD) (clinicaltrials.gov) - P1; N=64; Recruiting; Sponsor: UCB Biopharma SRL; Suspended ➔ Recruiting

Clinical • Enrollment open • CNS Disorders • Movement Disorders • Parkinson's Disease

A Safety and Pharmacokinetics Study of UCB7853 in Healthy Study Participants and Study Participants With Parkinson's Disease (PD) (clinicaltrials.gov) - P1; N=64; Suspended; Sponsor: UCB Biopharma SRL; Trial completion date: Sep 2022 ➔ Apr 2023; Trial primary completion date: Sep 2022 ➔ Apr 2023

Clinical • Trial completion date • Trial primary completion date • CNS Disorders • Movement Disorders • Parkinson's Disease

A Safety and Pharmacokinetics Study of UCB7853 in Healthy Study Participants and Study Participants With Parkinson's Disease (PD) (clinicaltrials.gov) - P1; N=64; Suspended; Sponsor: UCB Biopharma SRL; Recruiting ➔ Suspended

Clinical • Trial suspension • CNS Disorders • Movement Disorders • Parkinson's Disease

A Safety and Pharmacokinetics Study of UCB7853 in Healthy Study Participants and Study Participants With Parkinson's Disease (PD) (clinicaltrials.gov) - P1; N=64; Recruiting; Sponsor: UCB Biopharma SRL; Trial completion date: Jun 2022 ➔ Sep 2022; Trial primary completion date: Jun 2022 ➔ Sep 2022

Clinical • Trial completion date • Trial primary completion date • CNS Disorders • Movement Disorders • Parkinson's Disease

A Safety and Pharmacokinetics Study of UCB7853 in Healthy Study Participants and Study Participants With Parkinson's Disease (PD) (clinicaltrials.gov) - P1; N=64; Recruiting; Sponsor: UCB Biopharma SRL; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • CNS Disorders • Movement Disorders • Parkinson's Disease

A Safety and Pharmacokinetics Study of UCB7853 in Healthy Study Participants and Study Participants With Parkinson's Disease (PD) (clinicaltrials.gov) - P1; N=64; Not yet recruiting; Sponsor: UCB Biopharma SRL

Clinical • New P1 trial • CNS Disorders • Movement Disorders • Parkinson's Disease