levodopa pro-drug/carbidopa (ONO-2160/CD) / Ono Pharma - LARVOL DELTA

[VIRTUAL] Assessing the Safety and Tolerability of ABBV-951 (Foscarbidopa/Foslevodopa) in Advanced Parkinson’s Disease Patients During a 52-Week Phase 3 Study: Study Design and Updated Patient Baseline Characteristics (MDS Congress 2020) - P3 | "Foscarbidopa/foslevodopa is a new soluble formulation of carbidopa and levodopa prodrugs being developed for the treatment of aPD as a CSCI via an external pump. Foscarbidopa/foslevodopa has the potential to provide a wide range of individualized doses of levodopa via a continuous 24 h/day infusion and offers a non-surgical treatment option for patients with aPD whose motor complications are inadequately controlled by conventional medications. The currently enrolled study population have baseline demographics and disease characteristics that are comparable to those of subjects enrolled in other studies with aPD patients."

Clinical • P3 data • CNS Disorders • Parkinson's Disease

[VIRTUAL] Daily Time-Course of Efficacy of Continuous Subcutaneous Infusion of Foslevodopa/foscarbidopa in Advanced Parkinson’s Disease Patients from a Phase 1b Study (MDS Congress 2020) - P1 | "Background: As PD progresses, symptoms are no longer well controlled by oral medication due to a narrowing therapeutic window.  Foslevodopa/foscarbidopa is a new soluble formulation of carbidopa and levodopa prodrugs designed to maintain stable levodopa exposure for 24h/day delivery via CSCI. Compared to oral LD/CD, foslevodopa/foscarbidopa decreased “Off” time while increasing “On” time without dyskinesia, reducing fluctuations over the day.  The amount of dyskinesias, both troublesome and non-troublesome was also reduced and more stable over the day.  This suggests that achieving a stable pharmacokinetic (PK) profile with foslevodopa/foscarbidopa throughout the day reduces motor fluctuations."

Clinical • P1 data • CNS Disorders • Parkinson's Disease

Safety and Tolerability in Parkinson’s Disease Patients Treated with a Continuous Subcutaneous Infusion of ABBV-951: Design of a 52-Week Phase 3 Study (AAN 2020) - P3 | "Background: ABBV-951 is a new soluble formulation of carbidopa and levodopa prodrugs being developed for the treatment of PD. ABBV-951 has the potential to provide a non-surgical treatment option for patients with PD whose motor complications are inadequately controlled by oral medications. The current study is designed to assess the 52-week safety and tolerability of personally titrated therapeutic doses of ABBV-951 continuously infused in PD patients in an outpatient setting."

Clinical • P3 data • CNS Disorders • Parkinson's Disease

Safety and Tolerability During a 4-Week Continuous Subcutaneous Infusion of ABBV-951, a New Drug Formulation for the Treatment of Parkinson’s Disease: Final Results of a Phase 1b Study (AAN 2020) - P1 | "Background: ABBV-951 is a new soluble formulation of carbidopa and levodopa prodrugs, delivered as a CSCI via an external pump, being developed for the treatment of PD. Results demonstrate that ABBV-951 was well-tolerated when delivered via 24-hour CSCI for 28 days and support future investigations of ABBV-951 as a potentially new treatment option for PD patients."

Clinical • P1 data • CNS Disorders • Parkinson's Disease

[VIRTUAL] Efficacy of continuous subcutaneous infusion of ABBV-951 on early morning symptoms in advanced Parkinson’s disease patients from a phase 1b study (EAN 2020) - P1 | "Background and aims: ABBV-951 (foslevodopa/ foscarbidopa) is a new soluble formulation of carbidopa and levodopa prodrugs designed for 24h/day delivery via continuous subcutaneous infusion (CSCI). In advanced PD patients, tested doses of foslevodopa/foscarbidopa were generally well-tolerated when delivered 24h/day via CSCI, reduced overall daily “Off” time and improved early morning symptoms."

Clinical • P1 data • CNS Disorders • Gene Therapies • Movement Disorders • Parkinson's Disease

Pharmacokinetics and safety/efficacy of levodopa pro-drug ONO-2160/carbidopa for Parkinson's disease. (PubMed, eNeurologicalSci) - "The combination of ONO-2160 and carbidopa produced a prolonged and stable plasma levodopa concentration with a reduction in Unified Parkinson's Disease Rating Scale Part III total scores. The combination was well tolerated, with no safety concerns, when administered to Japanese patients with Parkinson's disease."

Clinical • Journal • PK/PD data • Biosimilar • CNS Disorders • Gene Therapies • Genetic Disorders • Movement Disorders • Parkinson's Disease

Safety and Tolerability During a 4-Week Continuous Subcutaneous Infusion of ABBV-951, a New Drug Formulation for the Treatment of Parkinson’s Disease: Final Results of a Phase 1b Study (MDS Congress 2019) - P1; "Background: ABBV-951 is a new solution of carbidopa and levodopa prodrugs for continuous subcutaneous delivery. These results demonstrate that ABBV-951 is safe and tolerable when delivered via 24-hour CSCI for 28 days and support future investigations of ABBV-951 as a potentially new treatment option for PD patients."

Clinical • Late-breaking abstract • P1 data