Impel NeuroPharma has announced the initiation of the Phase 2a THOR 201 study of INP103 intranasal levodopa compared to placebo for the treatment of OFF episodes in Parkinson’s disease patients. INP103 is delivered by Impel’s Precision Olfactory Delivery (POD) device.
The safety and PK/PD study is expected to enroll 24 patients who will receive one of 3 doses of INP103 or placebo during an OFF episode. The primary endpoint is safety and tolerability 240 minutes post dosing and over the next 7 days.
Impel CEO Jon Congleton said, “We are pleased to initiate our Phase 2a study of INP103 in levodopa responsive PD patients which will explore the therapeutic potential for intranasal levodopa in the reversal of OFF episodes. Our goal is to bring innovative solutions that address unmet needs in people managing CNS disorders and this study is another example of that commitment.”
Chief Medical Officer Stephen Shrewsbury added, “We believe that Impel’s POD device will consistently and predictably deliver intranasal levodopa to Parkinson’s patients, to reverse their OFF time and gain a meaningful improvement in their activities of daily living. We look forward to reporting topline results from this study in the second half of 2018.”
Impel’s pipeline also includes intranasal dihydroergotamine for the treatment of migraine and intranasal insulin for the treatment of Alzheimer’s disease.
Read the Impel NeuroPharma press release.
