PureIMS gears up for abbreviated registration of Levodopa Cyclops® DPI against OFF episodes in Parkinson's disease with the successful completion of a comparative pharmacokinetic study

2024-01-18

引进/卖出临床2期

RODEN, Netherlands, Jan. 18, 2024 /PRNewswire/ --

PureIMS, a pharmaceutical company focused on the development of innovative inhalation products, this week reported it has completed a comparative pharmacokinetic study with Levodopa Cyclops®. The study results show rapid pulmonary absorption of levodopa in absence of safety and tolerability issues. These properties make Levodopa Cyclops® a prime candidate to treat Parkinson's Disease patients in OFF episodes and, by that, fulfill an unmet medical need. The study suggests a high comparability with a marketed inhaled levodopa product, which opens the path towards an abbreviated registration.

To manage OFF episodes in Parkinson's Disease and their inherent debilitating motoric consequences, a high absorption rate and rapid Cmax are essential PK parameters that determine how fast patients are relieved from these motor disturbances. Levodopa Cyclops® has now demonstrated to possess these PK properties.

In addition to the ideal PK performance, Levodopa Cyclops® has unrivaled ease of use in that it requires only two easy steps before use and does not need to be cleaned. This drastically improves its usability over other products for the intended, motorically impaired patient population. Pharmacodynamics of Levodopa Cyclops® were demonstrated in a phase II study in PD patients experiencing OFF episodes. A significant and clinically meaningful improvement of MDS-UPDRS-part III motor scores was already observed after 15-20 minutes.

Based on the data from this comparative study, PureIMS is now gearing up for an abbreviated registration path, which was determined in consultation with the FDA. Also for the European market PureIMS has worked out the clinical development trajectory. For both the US and EMA, PureIMS solicits partners for development and commercialization.

Prof. Dr. Teus van Laar, neurologist and clinical pharmacologist, UMC Groningen and Member of PureIMS' scientific advisory board:

"This randomized cross-over trial of Levodopa Cyclops® vs. Inbrija® in 26 healthy volunteers has shown that Levodopa Cyclops® is at least as good and safe as Inbrija®, showing a quicker absorption of levodopa during the first minutes. Levodopa Cyclops® will be a valuable medicine that enables fast and reliable relieve to patients with Parkinson's disease suffering from OFF periods"

Jaap Wieling, PureIMS' CEO commented:

"It has already been very stimulating to hear the feedback of Parkinson's patients about the unrivaled ease of use of Levodopa Cyclops® from the previous phase I, II and usability studies.

The data from this Levodopa Cyclops® comparative study are a confirmation of the company's expectations of the great dispersion capabilities of Cyclops® DPI and the benefits for a range of systemic and pulmonary diseases. It brings us in the next stage of the company's life cycle, where we will bring a range of pipeline products to the market and where we co-develop inhalable products for systemic and pulmonary indications with our pharma and biotech partners."

About PureIMS B.V.

PureIMS, a Netherlands-based pharmaceutical company, owns exclusive worldwide license rights of Cyclops®, a high-dose dry-powder patient-centric inhaler for rapid and controlled drug delivery, easy-to-use, comfortable, pre-filled, and disposable, ensuring high-dose delivery and a fast onset of action. The inhaler is a superior alternative to a wide range of oral and parenteral dosage forms for pulmonary, systemic and rescue indications. Recently the company closed collaborative agreements for the application of Cyclops™ in the development of therapeutics for NTM and IPF, for pulmonary diagnostic purposes and for inhaled vaccination.

In addition to partnering programs, PureIMS has a clinical stage in-house pipeline also open to outlicensing; lead programs are Cyclops™ inhalers for levodopa (PD), epinephrine (anaphylaxis) and colistin (CF and NCFB).

PureIMS' first product Colistin Cyclops™ to treat P. aeruginosa infection in CF patients, is already provided to patients as an extemporaneously compounded product, and first steps are taken to initiate full development for marketing in the US and Europe.

With Cyclops®, for which single-use and multi-use alternatives are available, PureIMS has also enthused pharma/biotech companies looking for innovative pulmonary delivery options to develop inhaled small and large molecule products for local and systemic indications in early-clinical endeavors. The Cyclops™ technology is also ideally suited for 'rescue applications' in areas with an acute unmet need. Levodopa Cyclops® and Epinephrine Cyclops® are an exponent of this class of products.

For more information, please visit www.pureims.com

For further inquiries, please contact:

Jaap Wieling, CEO

PureIMS bv

Ceintuurbaan Noord 152

9301NZ RODEN, The Netherlands

+31620335602

[email protected]

SOURCE PureIMS