Dizlin Pharmaceuticals publishes data from pharmacokinetic study (PK) (IPO-001) with Infudopa SubC (DIZ102) and Infudopa IntraV (DIZ101) in Neurology

Gothenburg, Sweden, September 7, 2022 – Dizlin Pharmaceuticals AB, a research-based pharmaceutical development company with focus on diseases of the central nervous system (CNS), announces that an article has been published in Neurology®, from the American Academy of Neurology®, describing data from the company’s IPO-001 pharmacokinetic cross-over study.  

• In a pharmacokinetic cross-over study comprising 18 evaluable subjects with advanced Parkinson´s disease, levodopa/carbidopa solutions with a pH of 5.5 were produced by continuous buffering shortly prior to intravenous (DIZ101) or subcutaneous (DIZ102) administration.

• During the 16h of infusion, both DIZ101 and DIZ102 displayed plasma levels of levodopa comparable to those obtained by means of dose-adjusted intestinal administration of a levodopa/carbidopa gel (Duodopa, LCIG) – predefined bioequivalence aims of the study were hence met.

• The bioavailability of levodopa was 100% with subcutaneous administration of DIZ102 and 80% with intestinal administration of LCIG.
   
• Skin-related side effects were generally absent or mild.

“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.

“The data were those that we had hoped for,” says Björn Velin, CEO of Dizlin Pharmaceuticals. “The results suggest that DIZ102 (Infudopa SubC™), administered by means of a portable twin pump, may serve as a levodopa/carbidopa monotherapy for patients requiring high levodopa levels but experience motor fluctuations when receiving oral administration. The rapid uptake of levodopa from the subcutaneous tissue would enable considerable flexibility in dosing, which we also regard as an important advantage. Unlike intestinal administration of a levodopa/carbidopa gel, Infudopa SubC™ requires no surgery and displays considerable room temperature stability prior to mixing.”

The article in Neurology is accessible for free at:  https://n.neurology.org/content/99/10/e965

This release discusses investigational uses of products in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such product will successfully complete clinical development or gain health authority approval.

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

The information was released for public disclosure, through the agency of the contact person above, on September 7, 2022.

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).

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