Easy-to-use inhaled levodopa system readying request for US approval
Faster levodopa absorption seen with Cyclops system than Inbrija in trial
Levodopa Cyclops, an inhaled version of levodopa that PureIMS is developing as a treatment for off episodes with Parkinson’s disease, safely delivers levodopa to the body faster than an existing inhaled formulation of the therapy.
That’s according to results from a company-sponsored clinical trial (NCT06037590) comparing the pharmacological properties of Levodopa Cyclops against those of Inbrija, an approved inhaled powder formulation of levodopa developed by Acorda Therapeutics.
“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,” Teus van Laar, MD, PhD, a neurologist and member of PureIMS’ scientific advisory board, said in a company press release.
The investigative formulation also is reported to be easier and more convenient for patients to use.
Goal is to provide a boost of levodopa during Parkinson’s off episodes
After consultation with the U.S. Food and Drug Administration (FDA), PureIMS plans to pursue an abbreviated registration path to get Levodopa Cyclops approved for use in the U.S. The company also will seek its approval in Europe, and is looking for partners to develop and commercialize the therapy in both markets.
“The data from this Levodopa Cyclops comparative study are a confirmation of the company’s expectations of the great dispersion capabilities of Cyclops [dry powder inhaler] and the benefits for a range of systemic and pulmonary diseases,” said Jaap Wieling, CEO of PureIMS.
Parkinson’s is characterized by the progressive death and dysfunction of nerve cells in the brain that are responsible for producing dopamine, an important chemical messenger. Reduced dopamine signaling ultimately gives rise to most disease symptoms.
Levodopa is a mainstay treatment for Parkinson’s; it basically works by giving the brain more raw materials with which to make dopamine. While standard oral formulations of levodopa generally are quite effective for easing symptoms, in the long run patients experience off episodes, periods when symptoms aren’t well-controlled between scheduled levodopa doses.
Inhaled versions like Inbrija and Levodopa Cyclops aim to provide a quick boost of levodopa between scheduled doses, helping to control symptoms during off episodes. PureIMS said trial data indicate that the Levodopa Cyclops system delivers levodopa into the body more quickly than Inbrija. In studies, patients also experienced less severe Parkinson’s motor symptoms within 15 to 20 minutes after dosing, the company noted.
According to van Laar, these results suggest that “Levodopa Cyclops will be a valuable medicine that enables fast and reliable [relief] to patients with Parkinson’s disease suffering from OFF periods.”
The Levodopa Cyclops system also offers “unrivaled ease of use,” the company reports, noting its requires two straightforward steps and doesn’t need cleaning. While the company offers both single- and multiple-use devices, a single-use dry powder inhaler is intended for Parkinson’s, a company webpage states.
“It has already been very stimulating to hear the feedback of Parkinson’s patients about the unrivaled ease of use of Levodopa Cyclops,” Wieling said.
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