Levodopa Cyclops / PUREIMS - LARVOL DELTA

Usability of Levodopa Cyclops® Compared to INBRIJA® During an off Episode in Parkinson's Disease Patients. (PubMed, J Aerosol Med Pulm Drug Deliv) - "The Cyclops® inhaler was more user-friendly during off episodes due to its ease of use and simpler handling. Since the Cyclops® is preloaded, it requires fewer and simpler steps. The preparation steps of Inbrija® posed usability challenges, particularly with opening the peel-off blister packaging of the capsule and assembling the mouthpiece and handle."

Journal • CNS Disorders • Movement Disorders • Parkinson's Disease

An In Vitro-In Vivo Comparison of Two Levodopa Dry Powder Products for Inhalation: A Randomized Trial Comparing Inbrija and Levodopa Cyclops. (PubMed, Pharmaceutics) - " This suggests that the systemic absorption of levodopa via the lungs is not limited by dissolution but most likely by its permeation rate. This finding underscores the need to critically apply in vitro tests and critically interpret the results for predicting the in vivo performance of inhaled products."

Journal • Preclinical • CNS Disorders • Movement Disorders • Parkinson's Disease

DPI-6: Usability of Levodopa Cyclops™ vs INBRIJA® in Parkinson's Patients (clinicaltrials.gov) - P=N/A | N=16 | Completed | Sponsor: Martini Hospital Groningen | Recruiting ➔ Completed | Trial completion date: Dec 2024 ➔ Jul 2024 | Trial primary completion date: Nov 2024 ➔ Jul 2024

Trial completion • Trial completion date • Trial primary completion date • CNS Disorders • Movement Disorders • Parkinson's Disease

DPI-6: Usability of Levodopa Cyclops™ vs INBRIJA® in Parkinson's Patients (clinicaltrials.gov) - P=N/A | N=16 | Recruiting | Sponsor: Martini Hospital Groningen | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Movement Disorders • Parkinson's Disease

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 (Yahoo Finance) - P1 | N=26 | NCT06037590 | Sponsor: PureIMS B.V. | "PureIMS...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....The study suggests a high comparability with a marketed inhaled levodopa product, which opens the path towards an abbreviated registration....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."

P1 data • CNS Disorders • Parkinson's Disease

A Pilot Comparative Bioavailability Study of Levodopa Administered Via Levodopa Cyclopsâ„¢ Relative to INBRIJA® (clinicaltrials.gov) - P1 | N=26 | Completed | Sponsor: PureIMS B.V. | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Movement Disorders • Parkinson's Disease

DPI-6: Usability of Levodopa Cyclopsâ„¢ vs INBRIJA® in Parkinson's Patients (clinicaltrials.gov) - P=N/A | N=16 | Not yet recruiting | Sponsor: Martini Hospital Groningen | Trial completion date: Oct 2023 ➔ Dec 2024 | Trial primary completion date: Oct 2023 ➔ Nov 2024

Trial completion date • Trial primary completion date • CNS Disorders • Movement Disorders • Parkinson's Disease

A Pilot Comparative Bioavailability Study of Levodopa Administered Via Levodopa Cyclops™ Relative to INBRIJA® (clinicaltrials.gov) - P1 | N=26 | Active, not recruiting | Sponsor: PureIMS B.V. | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Movement Disorders • Parkinson's Disease

A Pilot Comparative Bioavailability Study of Levodopa Administered Via Levodopa Cyclops™ Relative to INBRIJA® (clinicaltrials.gov) - P1 | N=26 | Not yet recruiting | Sponsor: PureIMS B.V.

New P1 trial • CNS Disorders • Movement Disorders • Parkinson's Disease

PureIMS secures new investment round to develop lead inhalation product and facilitate partnering activities (PRNewswire.co.uk) - "PureIMS...today announced it has secured a new investment round. New investor Boost-UP Foundation has joined current shareholders (CardusoCapital venture capital fund, IMDS Medical Devices and LinesBridge Pharma Group) in this round to finance the company's ambitious growth strategy. The funds will be mainly used to develop lead program Levodopa Cyclops™ for US and EEA marketing, of which early clinical studies already demonstrated very rapid onset of action in combatting OFF-episodes in Parkinsons' disease, much faster than other inhaler and non-inhaler alternatives."

Clinical data • Financing