AMARIN ANNOUNCES POSITIVE DATA FROM TWO PHASE IIA STUDIES USING MIRAXION TO TREAT UNRESPONSIVE DEPRESSION

Amarin has announced positive data analysis from two exploratory Phase IIa clinical studies using Miraxion (formerly referred to as LAX-101c) to treat depression.

An analysis of the data from the two studies identifies a significant clinical benefit with Miraxion for a subgroup of patients with specific symptomology. In a recent exploratory Phase IIa study, Miraxion was used as monotherapy in 77 patients with a new episode of depression in a six-week trial.

In this study it was prespecified, that the presence of specific depression symptomology (patients with melancholic vegetative symptoms) at the time of entry to the study, would predict response.

In an exploratory analysis the Bech-Depression Scale, a subscale of the Hamilton Depression Rating Scale, which defines the affective core symptoms of depression, was used as the outcome variable. Miraxion achieved statistical significance over placebo in the subgroup of patients meeting these criteria. In addition, using identical symptom-specific methodology, statistically significant results were obtained by reanalyzing the dataset from a published, randomized, placebo-controlled study in treatment unresponsive depression, where Miraxion was used as an adjunct therapy with standard depression treatments.