Our studies
Efficacy Data from IPO-001 Study
As reported in a previous paper, pharmacokinetic data from a cross-over trial comparing Infudopa SubC® (DIZ102) (levodopa plus carbidopa administered subcutaneously), Infudopa IntraV® (DIZ101) (levodopa plus carbidopa administered intravenously), and LCIG (Duodopa®) (levodopa plus carbidopa administered intestinally) in 18 patients with Parkinson´s disease revealed the three treatments to produce similar plasma levels of levodopa during a 16h infusion; in contrast, plasma carbidopa levels were higher with Infudopa SubC and Infudopa IntraV than with LCIG (Bergquist et al, Neurology 2022: 99: e965-e976).
Efficacy data from the same trial have now been reported as a poster at the International Congress of Parkinson´s Disease and Movement Disorders in Copenhagen August 27-31 – Bergquist et al, Motor function in Parkinson’s disease during 16h treatment with intravenously (DIZ101), subcutaneously (DIZ102), or intestinally (LCIG) infused levodopa.
The participants of the study had been video-recorded at baseline and at five different occasions while performing tasks from the motor examination part of the Unified Parkinson’s Disease Rating Scale (UPDRS); these recordings were subsequently evaluated by raters blinded with respect to treatment. In addition, motor function was measured using a wrist-worn device monitoring bradykinesia, dyskinesia, and tremor (Parkinson KinetiGraph®).
Neither of the assessments suggested inferior efficacy of Infudopa administered subcutaneously or intravenously as compared to LCIG administered intestinally.
Link to the poster: DIZ101 DIZ102 motor efficacy MDS2023 poster
Pharmacokinetic study
A pharmacokinetic* (PK) study aimed to serve as basis for an application for marketing authorization for Infudopa IntraV™ and Infudopa SubC™ was completed in April 2020.
Eighteen patients with Parkinson´s disease normally treated with Duodopa®/Duopa® were studied at three separate occasions – on one day with a continuous intravenous infusion of Infudopa IntraV™, on another day with a continuous subcutaneous infusion of Infudopa SubC™ and on a third day with continuous duodenal administration of Duodopa®/Duopa®. Each administration lasted for 16 hours.
The patients varied with respect to their regular Duodopa®/Duopa™ dose requirements, those at highest dosage receiving 2019 mg/day. Doses of Infudopa IntraV™ and Infudopa SubC™ were adjusted to be equivalent to the regular Duodopa®/Duopa® dose for the patient in question.
Study results
The primary aims of the study, to show bioequivalence of Infudopa SubC™ and Duodopa®/Duopa® with respect to levodopa levels in plasma, and non-inferiority with respect to plasma level fluctuations, were all met. A comparison of levodopa levels following Infudopa SubC™ and Infudopa IntraV™, respectively, shows levodopa bioavailability for Infudopa SubC™ to be close to 100%. Effects on motor symptoms were the same for the three treatment groups. Local side effects of Infudopa SubC™ at the infusion site were mild or moderate.
* Pharmacokinetics defines what the body does to the drug. Pharmacokinetics is the study of a drug´s absorption, distribution, metabolism and elimination from the body. The pharmacokinetic properties determine the onset, intensity, and the duration of drug action.
Pharmacokinetics of Intravenously (DIZ101), Subcutaneously (DIZ102), and Intestinally (LCIG) Infused Levodopa in Advanced Parkinson Disease.
Please review full article and/or download full article from . https://n.neurology.org/content/99/10/e965
Clinical tolerability study*
A clinical outpatient tolerability study is scheduled to start in H2 2024. The duration, size and design of this study is pending consultations with relevant authorities.
* A clinical study is a research trial involving human subjects. Tolerability refers to the occurrence of adverse effects of a drug and how these are tolerated by the patient.