Benjorna (delayed-release and extended-release methylphenidate capsules) meets endpoints for ADHD patients in Phase III (HLD200- 107)trial.-Highland Therapeutics.

Highland Therapeutics Inc.’s wholly owned subsidiary, Ironshore Pharmaceuticals & Development, Inc. announced positive clinical data from the first of two Phase III pivotal trials of its investigational drug product, Benjorna (delayed-release and extended-release methylphenidate capsules). Benjorna, formerly referred to as HLD-200, is under development as a potential new option for physicians treating patients with Attention Deficit Hyperactivity Disorder (ADHD).

In the clinical study (HLD200- 107), which included 153 pediatric patients, those who were randomized to receive Benjorna demonstrated a statistically significant improvement compared to those patients who received placebo (p=0.01), based on a composite measure from 8am through to 8pm on the Swanson, Kotkin, Agler, M-Flynn and Pelham (SKAMP) Rating Scale, the study’s primary endpoint. Patients randomized to the Benjorna treatment arm also demonstrated improved functioning during the morning routine as measured by the PREMB-R (Parent Rating of Evening and Morning Behavior-Revised) morning (AM) subscale, which was the study’s key secondary endpoint (p<0.001). The potential for Benjorna to improve functioning during the morning routine will be evaluated further in a second pivotal study (HLD200-108), which is currently ongoing with results expected in the second quarter of 2016.

In the HLD200-107 study, the Benjorna treatment group also achieved statistically significant mprovement, compared with placebo, in functioning in the evening as measured by the PREMB-R evening (PM) subscale (p<0.001). The extended duration of clinical effect was previously observed in a prior Phase III study, conducted in 2014, in which patients receiving evening-dosed Benjorna showed improved functioning through to 8pm the following day, the last time point measured.

Ironshore intends to advance two new drug candidates into pivotal trials in the second half of 2016: HLD-900, an amphetamine-based product for the treatment of Binge Eating Disorder (BED) which was the subject of an End of Phase II (EOP2) meeting held with the FDA in February 2016, and HLD-100, which is under development as an amphetamine-based treatment for patients with ADHD.

Comment:The technology provides a delay in the initial release of the active drug, followed by a period of extended release to provide control of ADHD symptoms immediately upon wakening and throughout the day.