PureIMS announced that a Phase 1 PK study that compared the company’s Levodopa Cyclops to Inbrija levodopa DPI, demonstrated “high comparability with a marketed inhaled levodopa product,” with faster initial absorption and no safety or tolerability concerns reported. The company announced the initiation of the Phase 1 study in August 2023.
The company says that it has consulted with the FDA, and based on the results of the PK study and an as-yet unpublished Phase 2 PD study, PureIMS said that it “is now gearing up for an abbreviated registration path.” According to the announcement, the company is also developing Levodopa Cyclops for the European market and has consulted with the EMA regarding clinical trial requirements.
PureIMS CEO Jaap Wieling 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 1, 2, 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.”
Read the PureIMS press release.
