First Subject Dosed In Phase 1 Trial Evaluating INP105

Impel NeuroPharma announced the first subject has been dosed in a Phase 1, randomized, double-blind, placebo-and-active controlled crossover study of their intranasal olanzapine product, INP105, dosed via Impel's proprietary Precision Olfactory Delivery, or POD, intranasal delivery device. INP105 is being studied for the treatment of acute agitation in bipolar I disorder and schizophrenia.

The "SNAP 101" Trial (Safety and Tolerability of Intranasal POD-olanzapine) will evaluate the safety, tolerability and pharmacokinetic/pharmacodynamic (PK/PD) profile of INP105 at three ascending doses compared with two doses of Zyprexa intramuscular (5 mg and 10 mg) and orally disintegrating Zyprexa Zydis (10 mg) in 36 healthy volunteers. The aim of the SNAP 101 trial is to establish the safety and tolerability of INP105 while informing appropriate dosing for future studies based on the PK and PD profiles.

"The evolution of mental healthcare options and treatments in the US is a priority, and there is a specific unmet need for optimal treatments that could address acute agitation," said Jon Congleton, Chief Executive Officer of Impel NeuroPharma. "Our goal with INP105 is to provide an easy-to-administer, rapidly-acting medicine that addresses acute agitation with a therapy that can be used in both the hospital and home setting without an injection."

Acute agitation often manifests in patients with serious underlying mental health conditions such as bipolar I disorder or schizophrenia. Between 1.7 million and 7 million episodes of acute agitation have been reported to occur in US hospitals and emergency room settings each year. An ideal medication for acute agitation, according to a 2005 expert consensus is easy-to-administer, non-traumatically administered, provides rapid tranquilization without excessive sedation, has a swift onset of action with sufficient duration to prevent untimely recurrence and has low risk for adverse events and drug interactions.

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