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KemPharm’s KP415, An Investigational Prodrug of D-Methylphenidate, Completes Phase 1 Proof-of-Concept Trial for the Treatment of ADHD

KemPharm’s KP415, An Investigational Prodrug of D-Methylphenidate, Completes Phase 1 Proof-of-Concept Trial for the Treatment of ADHD

Both Early and Extended Release of the Methylphenidate Prodrug was observed in the KP415.101 Study

Conference Call and Live Audio Webcast with Dr. Scott Kollins Scheduled for Today at 4:30 p.m., ET

CORALVILLE, Iowa, Dec. 14, 2016 (GLOBE NEWSWIRE) -- KemPharm, Inc. (KMPH), a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, today announced the results of its Phase 1 proof-of-concept clinical trial of KP415, KemPharm’s prodrug, extended release (ER) d-threo-methylphenidate (d-MPH) product candidate for the treatment of attention deficit hyperactivity disorder (ADHD). Data from the study indicated that KP415 demonstrated pharmacokinetic (PK) properties that produced earlier d-MPH exposure followed by a slower extended release of d-MPH relative to the comparator, Concerta®.

“In this study, the PK data suggest several potential clinically beneficial features of KP415, if it is approved, including a relatively rapid increase and higher overall plasma d-methylphenidate levels compared to other formulations,” said Scott Kollins, Ph.D., Professor and Vice Chair for Research Strategy and Development and the Director of the Duke University ADHD Program, following his independent review of the data. “Though additional studies will be necessary to evaluate the safety, efficacy and potential benefits of KP415, the data suggest that the prodrug design of this product could allow for once-daily dosing with a potentially improved onset of action. The prodrug design of KP415 may also add the significant benefit of a lower abuse potential, which could be an important public health benefit.”

“We are very pleased with the results of the Phase 1 study of KP415, which demonstrated that the prodrug may, if approved, offer ADHD patients a faster onset of action and a durable therapy. These are properties not seen with any currently marketed ADHD products,” stated Travis C. Mickle, Ph.D., President and Chief Executive Officer of KemPharm. “We believe these attributes may differentiate KP415 from currently marketed and development stage methylphenidate products. The methylphenidate portion of the ADHD market, which is estimated at approximately 19.7 million prescriptions and $4.2 billion in sales for 2015, makes KP415 one of our highest priority pipeline candidates. The next phase in KP415’s development is the completion of pivotal studies in 2017, leading...


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