GEORGE TOWN, Cayman Islands--(BUSINESS WIRE)--Ironshore Pharmaceuticals & Development, Inc. (“Ironshore”), a wholly owned subsidiary of Highland Therapeutics Inc. and the global leader in the development of novel treatments for Attention-Deficit/Hyperactivity Disorder (ADHD), today announced the presentation of new analyses of pivotal trial data for evening-dosed HLD200, also known as DR/ER-MPH (delayed-release and extended-release methylphenidate) at the American Academy of Child and Adolescent Psychiatry (AACAP) annual meeting, being held in Washington, DC. HLD200 is Ironshore’s investigational drug candidate for the treatment of ADHD.
David Lickrish, Ironshore’s Chief Executive Officer stated, “At a time when patients and physicians desire more than simple reformulations of medications, we are pleased to present novel data for HLD200 that we believe support comprehensive coverage and clinically meaningful improvement in at-home functional impairment during the early morning, late afternoon and evening in children with ADHD.”
“We know there is a growing sense of awareness among healthcare professionals who treat ADHD about the challenges associated with the early morning routine; typically the most chaotic time of the day for families and one not well served by existing treatment options,” said Dr. Randy Sallee, Chief Medical Officer of Ironshore Pharmaceuticals Inc. “Importantly, there are rating scales that assess functional impairment in ADHD patients during this period – the Before School Functioning Questionnaire (BSFQ) and the Parent Rating of Evening and Morning Behavior-Revised (PREMB-R) scale, which includes both morning and late afternoon/evening subscales. I invite all physicians and other healthcare professionals to evaluate the use of these assessment tools within their clinical practice.”
Details of Ironshore’s newly released data analyses are below:
New Research Poster Session 1
Poster #: 1.53
Clinically Meaningful Improvements with DR/ER-MPH in At-Home Functional Impairment During the Early Morning, Late Afternoon, and Evening in Children with Attention-Deficit/Hyperactivity Disorder
In this post hoc analysis, the BSFQ and PREMB-R AM (morning subscale) and PREMB-R PM (evening subscale), measures of at-home temporal functional impairment, were linked to a clinically meaningful global assessment, using the Clinical Global Impression-Improvement (CGI-I) scale, to aid in interpreting the clinical relevance of the findings in Ironshore’s Phase 3 clinical trial of HLD200 in children with ADHD (Study HLD200-108).
Following three weeks of treatment, a significantly higher proportion of children receiving HLD200, compared with placebo, met the criteria for clinical meaningful improvement on the BSFQ, PREMB-R AM, and PREMB-R PM (p=0.012, p<0.001 and p=0.01, respectively).
Two other posters will be presented at the New Research Poster Session 3, on Thursday, October 26, 2017 from 10:00am to 12:30pm EDT. Details are as follows:
Poster #: 3.28: At-Home Functional Impairment in Youth With ADHD: Factor Structure and Norm-Referenced Cut-off Points for the Before School Functioning Questionnaire and Parent Rating of Evening and Morning Behavior Scale–Revised
Poster #: 3.29: Psychometric Validation of the Before School Functioning Questionnaire and Parent Rating of Evening and Morning Behavior Scale–Revised in Children With Attention-Deficit/Hyperactivity Disorder
About Ironshore Pharmaceuticals & Development, Inc.
Ironshore Pharmaceuticals & Development, Inc., a wholly owned subsidiary of Highland Therapeutics Inc., is a pharmaceutical company that is leveraging its proprietary technology, DELEXIS®, to optimize the delivery of previously approved drug products.
Highland Therapeutics Inc. is a client of MaRS Discovery District’s Health Venture Services group, which provides advisory services, connections to talent, customer & capital networks, and market intelligence to high-impact, Ontario-based life sciences ventures, helping them commercialize their ideas and build globally competitive companies.
Forward-Looking Statements
This press release contains forward-looking information, which reflects Ironshore’s current expectations regarding future events. Forward-looking information is based on a number of assumptions and is subject to a number of risks and uncertainties, many of which are beyond Ironshore’s control that could cause actual results and events to differ materially from those that are disclosed in or implied by such forward-looking information. These forward-looking statements are made as of the date of this press release and, except as expressly required by applicable law, Ironshore assumes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
