Impel Neuropharma Announces First Patient Dosed In INP104 Trial

Impel NeuroPharma announced the first patient has been dosed in the company's Phase 3, open-label safety and tolerability study evaluating long-term, intermittent use of INP104 for the treatment of migraine headache. INP104 is a novel dihydroergotamine (DHE) product dosed via Impel's proprietary Precision Olfactory Delivery, or POD, intranasal delivery device.

The STOP-301 Trial (Safety and Tolerability of POD-DHE) will evaluate the safety and tolerability of long-term, intermittent use of INP104 for 24-week and 52-week data points and will also collect efficacy data of INP104 as assessed by change from baseline in migraine measures during the course of the study. Pending complete review of the clinical study data and as a result of rapid recruitment, the company expects to be in a position to file a New Drug Application (NDA) for INP104 in the second half of 2019.

"We are very pleased with the speed of recruitment to the STOP-301 study and anticipate that this reflects the level of unmet need in the market and enthusiasm for novel treatments," said Jon Congleton, Chief Executive Officer of Impel NeuroPharma. "We believe that INP104 stands to provide a gold-standard migraine therapy in a device that offers rapid and optimized bioavailability."

Migraine affects more than 36 million people in the United States, but only five million people are treating their migraine with a prescription medication. Over 70 percent of treated patients report dissatisfaction with currently-available treatments in controlling their acute migraines.

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