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Dizlin Pharmaceuticals AB, a research-based pharmaceutical development company with focus on diseases of the central nervous system, today announces that the paper “Motor Efficacy of Subcutaneous DIZ102, Intravenous DIZ101 or Intestinal Levodopa/Carbidopa Infusion” was published in Movement Disorder Clinical Practice on June 24, 2024.

The main objective of this 16h inpatient study was to investigate if the relatively high carbidopa blood concentrations following subcutaneous or intravenous infusion of levodopa (LD) plus carbidopa (CD) solutions (both with an LD/CD ratio of 8:1) – Infudopa SubC (DIZ102) and infudopa IntraV (DIZ101) – might counter the effect of levodopa with respect to impact on motor symptoms in patients with Parkinson´s disease. The results however provide no support for poorer levodopa efficacy with Infudopa SubC or infudopa IntraV than with a treatment producing similar levodopa but lower carbidopa levels, i.e., the intestinally administered Duodopa (LCIG).

”This was a 16h trial in a small number of PD subjects and hence does not permit any firm conclusion with respect to the long-term efficacy of Infudopa SubC. However, since the patients served as their own controls at three different occasions where levodopa levels were similar but carbidopa levels markedly different – i.e., relatively high with Infudopa SubC and Infudopa IntraV but lower with Duodopa – the study design was well suited to address if plasma carbidopa levels higher than those usually obtained with oral levodopa/carbidopa or Duodopa might impact levodopa efficacy negatively. The finding of similar responses with the three treatments, with no tendency for more bradykinesia when subjects received DIZ101 or DIZ102, hence provides strong support for the conclusion that carbidopa levels of the magnitude obtained with Infudopa do not counter the efficacy of levodopa. We hence find it likely that Infudopa SubC will prove as effective as Duodopa when introduced clinically” says Björn Velin, CEO of Dizlin Pharmaceuticals.

For more information please see the abstract at: https://pubmed.ncbi.nlm.nih.gov/38924339/

or please contact:

Björn Velin, CEO, Dizlin Pharmaceuticals AB
Cell phone: +46 (0)76 879 23 25, e-mail: bjorn.velin@dizlin.se

Elias Eriksson, Professor, Gothenburg University
Cell phone: + 46 (0)70 955 50 55, e-mail: elias.eriksson@neuro.gu.se

About Infudopa IntraV®
Infudopa IntraV™ (DIZ101) is a levodopa-carbidopa solution aimed to be administered intravenously using infusion pumps to inpatients who cannot receive oral administration of levodopa when being the subject of surgery with general anesthesia.

About Infudopa SubC®
Infudopa SubC™ (DIZ102) is a levodopa-carbidopa solution intended for outpatient treatment. Used with a portable twin pump enabling continuous mixing prior to infusion, Infudopa SubC™ is aimed as monotherapy for subjects who experience moderate to severe motor fluctuations when receiving oral administration of levodopa. When reaching the patient, Infudopa SubC™ displays a physiologically acceptable pH which also seems to optimize efficient levodopa uptake. The shelf life is 36 months in refrigerator and at least three months at room temperature, which would represent a significant logistic advantage for patients, e.g., when traveling.

About Parkinson’s disease
Parkinson´s disease (PD) is a serious neurodegenerative disease afflicting more patients than multiple sclerosis, amyotrophic lateral sclerosis, muscular dystrophy, and myasthenia gravis combined. Characterized by bradykinesia (poverty of motion), tremor, and muscular rigidity, and caused by degeneration of neurons using dopamine as transmitter, PD is a chronic and progressive condition, with a prevalence of 1% over the age of 60 and 3% of those over 75.

About Dizlin Pharmaceuticals
Dizlin Pharmaceuticals AB is a privately held Swedish research-based pharmaceutical development company with focus on diseases of the central nervous system in general and on developing improved treatment for advanced stages of Parkinson’s disease in particular. The company conducts research in collaboration with researchers at the University of Gothenburg and Linköping University in Sweden.
The company has developed a new patented method for treatment of advanced stages of Parkinson’s disease. Dizlin Pharmaceuticals has two products in late phase development stage. The first – Infudopa IntraV™ – is administered intravenously to minimize risks associated with surgery on patients with Parkinson’s disease. The second – Infudopa SubC™ – is administered as a continuous subcutaneous infusion by means of a portable pump (similar to insulin infusion for diabetes).

Gothenburg, Sweden, September 13, 2023 – Dizlin Pharmaceuticals AB, a research-based pharmaceutical development company with focus on diseases of the central nervous system, has presented efficacy data from the IPO-001 pharmacokinetic cross-over study comparing Infudopa SubC (DIZ102), Infudopa IntraV (DIZ101), and LCIG (Duodopa) at the International Congress of Parkinson´s Disease and Movement Disorders in Copenhagen, August 27-31.

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.

“It should be underlined that efficacy was not a primary effect parameter of this study, and that the trial was not designed to detect subtle differences in this regard”, says Björn Velin, CEO of Dizlin Pharmaceuticals. “Nevertheless, we are highly encouraged by the observation that there was no tendency for inferior symptom reduction with Infudopa SubC or Infudopa IntraV as compared to LCIG, the latter being the golden standard for advanced levodopa treatment in patients with Parkinson´s disease and experiencing motor fluctuations when on oral levodopa. Obtaining similar efficacy as with LCIG, but with a non-invasive route of administration, as with Infudopa SubC, would be a major step forward with respect to the treatment of this disabling condition”.

“The outcome shows that subcutaneous administration of a continuously buffered levodopa solution could be a feasible technique to safely and rapidly obtain high and stable levodopa levels in patients with Parkinson´s disease”, says principal investigator Filip Bergquist, MD, senior consultant in neurology and professor of pharmacology.

Link to the poster

For more information, please contact:
Björn Velin, CEO, Dizlin Pharmaceuticals AB
Cell phone: + 46 (0)76 879 2325, e-mail: bjorn.velin@dizlin.se