Intranasal antipsychotic Ph I study begins with first participant dosed

By Maggie Lynch contact

- Last updated on GMT

(Image: Getty/peshkova)
(Image: Getty/peshkova)

Related tags: Clinical trial, phase I, Pharmacokinetics, intranasal

Impel Neuropharma announced the first participant have been dosed in a Phase I trial looking at safety and tolerability for the company’s intranasal olanzapine product.

INP105 intranasal, with the active anti-psychotic drug olanzapine, is in clinical trials to test safety, tolerability, and pharmacodynamics/pharmacokinetics (PD/PK) of the drug. Intranasal administration of INP105 is through Impel’s proprietary device, Precision Olfactory Delivery (POD).

The trial, “SNAP 101,” which just dosed its first participant, is using the contract research organization (CRO) Clinical Network Services (CNS).

According to Impel, “The POD, or Precision Olfactory Delivery, platform utilizes propellants (in most cases HFA [hydrofluoroalkane], a pharma industry standard propellant gas) to deliver drug into the upper nasal cavity.”

Impel further explained that intranasal drug delivery is beneficial for rapid response because the nasal cavity is vascular, ideal for drug deposition and absorption.

“Preclinical and clinical studies support the thesis that targeting this region yields consistent dosing, improved PK and the potential for better clinical outcomes.”

The trial is a Phase I, randomized, double-blind, and placebo-and-active crossover study with 36 healthy participants. Safety and tolerability will be evaluated through three ascending doses of INP105 to two doses of intramuscular Zyprexa, 5mg and 10mg, as well as orally disintegrating Zyprexa Zydis 10 mg. Olanzapine is the active ingredient in Zyprexa.

Appropriate dosing for future studies will be informed based upon the tolerability of the drug as well as the PD/PK profiles. Levels of sedation will also be tested through a positive and negative syndrome score.

Significant need for INP105

Impel chose olanzapine as the active ingredient in INP after preclinical trials showed that it could achieve an “ideal PK profile,” ​according to the company.

INP105 was developed to treat acute agitation in patients with bipolar I disorder and schizophrenia. According to the company, “Significant unmet need with agitation accounting for 1.7-7.0m emergency room visits per year, and the main alternative for intervention in an acute agitation event is intramuscular injection with an antipsychotic that is overly sedating.”

The drug candidate was developed for rapid tranquilizing, without excessive sedation, of patients in acute agitation. INP105 was developed to be used in an at-home or in-hospital setting. 

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