KemPharm Announces Positive Topline Results from KP415 Pharmacokinetic Study in Children and Adolescents With ADHD
Results Suggest that Data from Single Classroom-style Efficacy Study May Be Applicable Across Pediatric, Adolescent and Adult ADHD Patient Populations
“Two of the benefits of d-methylphenidate (d-MPH) are, according to published literature, drug exposure from a specific product is comparable between age groups after adjusting for dose and body weight, and there is a direct correlation between that exposure and the clinical response,” said
“This development adds to our excitement around KP415 as we anticipate additional clinical data throughout 2018, including topline results from the on-going pivotal efficacy study (KP415.E01) by mid-year,” added Mickle. “While awaiting complete analysis, the preliminary results from our KP415.105 trial leave us confident that the data currently being collected in our product efficacy trial will also provide support for effectiveness in the adolescent and adult populations.”
About the KP415.105 Study
Study KP415.105 was single-dose, single-period, PK study with a KP415/d-methylphenidate (d-MPH) capsule in children 6-12 years and adolescents 13-17 years old with ADHD. Each subject received one of two dose levels: 28/6 mg KP415/d-MPH (equivalent to 20 mg total d-MPH) or 56/12 mg KP415/d-MPH (equivalent to 40 mg total d-MPH). PK data were available and analyzed from 30 subjects: 10 children 6-8 years old received the 28/6 mg KP415/d-MPH capsule; 10 children 9-12 years old received the 56/12 mg KP415/d-MPH capsule; 10 adolescents 13-17-year-old received either the 28/6 or 56/12 mg KP415/d-MPH capsule (5 per treatment group). Body weights ranged from 21 kg to 73 kg. Consistent with published studies of methylphenidate pharmacokinetics, exposure of d-MPH decreased with age due to body weight differences between younger children and adolescents based on topline data. When normalized by dose and body weight, d-MPH exposure and PK parameters were comparable between age groups.
About KP415 – KemPharm’s Prodrug Composition of d-MPH for ADHD
KP415 is KemPharm’s d-MPH prodrug composition product candidate designed for the broad treatment needs of the ADHD population.
Caution Concerning Forward Looking Statements:
This press release may contain forward-looking statements made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include all statements that do not relate solely to historical or current facts, and can be identified by the use of words such as “may,” “will,” “expect,” “project,” “estimate,” “anticipate,” “plan,” “believe,” “potential,” “should,” “continue” or the negative versions of those words or other comparable words. Forward-looking statements are not guarantees of future actions or performance. These forward-looking statements include statements regarding the expected features and characteristics of KemPharm’s product candidates, including KP415, and any potential future clinical trial design for KP415, the ability of
|Investor Contacts:||Media Contact:|
|Jason Rando / Joshua Drumm, Ph.D.
Tiberend Strategic Advisors, Inc.
212-375-2665 / 2664
|Daniel L. Cohen
Executive VP, Government and Public Relations