EQS-News 145 0 Kommentare Data from Newron’s study 014/015 and an evenamide clinical development outlook presented at the 2024 Annual Congress of the Schizophrenia International Research Society (SIRS) - Seite 2

Also previously announced, in their totality, the results from study 014/015 support the initiation of a potentially pivotal phase III, randomized, double-blind, placebo-controlled study of evenamide as an add-on treatment in patients with TRS, which will hopefully confirm the benefit of evenamide observed so far. If approved, the compound would be the first add-on drug that improves the symptoms of TRS, offering a much-needed new therapeutic option for those who are not responding to existing antipsychotics. A poster outlining the design of this potentially pivotal study was presented at SIRS.

Newron is also investigating evenamide in a potentially pivotal study (study 008A) in a separate indication: in patients with chronic schizophrenia currently being treated with a second-generation antipsychotic, but who demonstrate an inadequate response to that treatment. Study 008A is a four-week, randomized, double-blind and placebo-controlled study assessing the efficacy, tolerability, and safety of evenamide (30 mg bid). Patient enrollment has completed and results from this study are expected in late April 2024. Additional information on this study was outlined in an oral presentation at SIRS.

The posters presented at the SIRS conference were titled:

Pharmaceutical pipeline: Glutamate modulation by evenamide as an add on to TRS patients not responding to current antipsychotics is associated with clinically important improvement across outcome measures: results from 1-year, open-label trial
Treatment with evenamide for 1 year in TRS patients not benefitting to current antipsychotics is associated with sustained, clinically important benefit: Results from a prospective, pilot, 1-year, randomized, open-label trial
Addition of evenamide for 1 year to antipsychotics in TRS patients results in increasing clinically important benefit to an extent that a substantial proportion no longer meet international criteria for treatment resistance
Design of a potentially pivotal, phase 3, international, randomized, double-blind, placebo-controlled clinical trial evaluating evenamide as add-on treatment for treatment-resistant schizophrenia (TRS) patients