Impel Commences Mid-Stage Autism Spectrum Disorder Study

Impel Pharmaceuticals IMPL has dosed the first patient in a Phase 2a proof-of-concept study of INP105, nasal olanzapine, a widely used atypical, second-generation antipsychotic.

The lead drug INP105 is being developed as an acute treatment for agitation in persons with autism spectrum disorder (ASD) using the proprietary Precision Olfactory Delivery (POD®) technology which delivers drugs to the upper nasal space.

The CALM 201 is a Phase 2a Proof-of-concept study designed to evaluate the safety, tolerability and exploratory efficacy using a number of adapted scales of a single dose of INP105 versus placebo in adolescents with autism spectrum disorder (ASD) experiencing agitation.

Adrian Adams, Chairman of the Board and Chief Executive Officer, commented : “The initiation of this trial is an important milestone for Impel as we advance our second compound, INP105, and build on our Phase 1 results which demonstrated that INP105 reached peak plasma levels approximately twice as fast as intramuscular olanzapine - currently marketed as Zyprexa - and ten-times faster than orally disintegrating tablets. We are optimistic about the potential benefits of INP105 based on previous study results and the positive impact we have seen with the POD technology with Trudhesa."

The company expects data readout from this study in the first quarter of 2023.

Price Action : Impel shares are trading around 3 percent higher at $8.29 on Tuesday at the time of publication.