Impel NeuroPharma has dosed the first subject in the Phase l Safety and Tolerability of Intranasal POD-olanzapine (SNAP 101) trial of INP105 for the treatment of acute agitation in bipolar I disorder and schizophrenia.
The randomised, double-blind, placebo-and-active controlled crossover trial is designed to evaluate the safety, tolerability and pharmacokinetic/pharmacodynamic (PK/PD) of INP105 in 36 healthy subjects.
During the study, three ascending doses of INP105 will be delivered to compare them with two doses of Zyprexa intramuscular and orally disintegrating Zyprexa Zydis.
Impel will use its precision olfactory delivery (POD) device for intranasal delivery of INP105 to the subjects.
The SNAP 101 trial intends to establish the safety and tolerability of INP105, as well as provide the appropriate dosing for future studies of INP105’s PK and PD profiles.
Impel NeuroPharma CEO Jon Congleton said: “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.
“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 is described as excessive motor activity related to a feeling of inner tension, often arises from serious underlying mental health conditions such as bipolar I disorder or schizophrenia.
Approximately 1.7 million to seven million episodes of acute agitation have been reported, or estimated, to happen in US hospitals annually.