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news.US-based pharmaceutical firm Highland Therapeutics' subsidiary Ironshore Pharmaceuticals & Development (Ironshore) has started patient enrollment in a Phase III trial to evaluate the safety and efficacy of HLD-200, a next-generation formulation of methylphenidate, in children with attention-deficit/hyperactivity disorder (ADHD).
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The multicenter, open-label treatment-optimized, double-blind, randomized, placebo-controlled, forced-withdrawal, parallel group Phase III trial is expected to generate top-line data by year-end.
HLD200 is a new delayed and extended release Formulation (DELEXIS) of methylphenidate hydrochloride.
Ironshore chief executive officer David Lickrish said: "The initiation of this pivotal study, the first of two we anticipate completing over the next six months, is a historic moment for the Company and the result of many years of dedication and passion from the remarkable team we have assembled.
"We have long believed that our products could change the way ADHD is treated given HLD-200’s potential for control over symptoms during the Early Morning Routine (EMR), a consistent clinical effect throughout the day and an extended duration of effect into the important evening homework period, representing a win-win-win for patients."
Around 150 pediatric patients between the ages of six and twelve will be enrolled in the trial across seven sites in the US.
The trial will use an open-label, treatment-optimization Phase, followed by a double-blind, placebo-controlled, 1-week, parallel-group study design to evaluate the safety and tolerability as well as the time-course of treatment effect of evening-dosed HLD-200 in pediatric subjects diagnosed with ADHD.
The new trial has been designed to build upon the successful results of the exploratory Phase III trial, known as CEES (Clinical Endpoint Evaluation Study), which was completed last yeart.
Ironshore chief medical officer Dr Randy Sallee said: "Impaired functioning during the morning routine as a result of uncontrolled ADHD symptoms is an important unmet medical need for which no practical solution exists today.
"The initiation of this study brings us one step closer to reaching one of Ironshore’s founding objectives – to provide such a solution. Should we also demonstrate an extended duration of effect, we believe HLD-200 could represent a first-line therapy in ADHD, potentially covering the ‘bookends’ of the patient’s day – from early morning to evening homework time.
"The results of this study, in conjunction with those of a second pivotal study we expect to initiate shortly, if successful, would provide Ironshore with a robust clinical package to submit as part of a New Drug Application in mid-2016."