Impel Pharmaceuticals said that it has initiated a Phase 2a study of its INP105 intranasal olanzapine in adolescents with autism spectrum disorder, with results expected early next year. In January 2019, Impel (then Impel Neuropharma) announced positive Phase 1 results for INP105, which it was developing at the time for the treatment of acute agitation in bipolar I disorder and schizophrenia.
The CALM 201 Phase 2a study is expected to enroll 32 participants aged 12 to 17 who have exhibited severe agitation and will compare a single 5 mg dose of INP105 to placebo in an inpatient setting. The study will focus on the incidence of adverse events and serious adverse events at 48 hours post dose and at 7 days. In addition, evaluations of behavior will take place at 30 minutes, 60 minutes, and 120 minutes post dose.
Impel Pharmaceuticals Chairman of the Board and CEO Adrian Adams said, “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. Autism is the fastest-growing developmental disorder in the United States and there is an unmet need to help those living with autism and its related effects. 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.”
Chief Medical Officer Stephen Shrewsbury commented, “Our hope is to create a medication that is easy-to-administer, provides rapid calming without excessive sedation, has a swift onset of action with sufficient duration to prevent untimely recurrence, and has minimal risk for adverse events and drug interactions. If successful, this trial will bring us one step closer to potentially helping millions of autistic people, their families, and caregivers better manage episodes of agitation.”
Read the Impel Pharmaceuticals press release.
