KemPharm Initiates Pivotal Efficacy Trial of KP415
January 08 2018 - 7:30AM
‘Classroom-style’ Pivotal Efficacy Trial of ADHD
Prodrug Composition Candidate to Study Onset and Duration of
Efficacy and Product Safety
KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty
pharmaceutical company engaged in the discovery and development of
proprietary prodrugs, today reported the successful initiation of a
“classroom-style” pivotal efficacy trial of KP415, the company’s
extended release (ER) d-methylphenidate (d-MPH) prodrug composition
product candidate for the treatment of Attention Deficit,
Hyperactivity Disorder (ADHD). The trial is designed to
support a potential label for KP415 for both an early onset and
long duration of a KP415 treatment effect in ADHD patients.
The trial is a multicenter, dose-optimized,
double-blind, randomized, placebo-controlled, parallel efficacy
laboratory classroom trial with children aged 6 to 12 years with a
diagnosis of ADHD. Screening for pediatric trial patients
began on November 20, 2017. Treatment with the study drug was
initiated in the first patient on December 20, 2017.
Enrollment in the trial is expected to total approximately 140
patients across five clinical sites in the United States, and it is
anticipated that all patients will have completed the trial by the
end of second quarter of 2018. Each patient will be treated
for a total of four weeks.
“The start of the KP415 pivotal efficacy trial
is a significant milestone in our effort to provide the first
product with a methylphenidate prodrug to ADHD patients,” said
Travis C. Mickle, Ph.D., President and Chief Executive Officer of
KemPharm. “The trial is designed to collect evidence for a
potential claim in the KP415 label indicating early onset and
extended treatment effect, both of which are unmet by current
methylphenidate products.”
“With this trial initiation, the KP415
developmental timeline for a possible NDA submission is estimated
to be as early as the first quarter of 2019,” added Mickle.
“We expect to have topline data from this trial to share as soon as
mid-2018, with a complete trial data set available prior to the end
of the year.”
KP415 – Prodrug Composition of d-MPH for
ADHD:
KP415 is KemPharm’s ER d-MPH prodrug composition
product candidate designed for the broad treatment needs of the
ADHD population. KemPharm believes KP415 may also demonstrate
a lower abuse potential as well as less variability in the delivery
of d-MPH compared to current methylphenidate
products.
KP415 Trial Information:
Details of the study design can be found at
https://clinicaltrials.gov/ct2/show/NCT03292952.
About KemPharm:
KemPharm is a clinical-stage specialty
pharmaceutical company focused on the discovery and development of
proprietary prodrugs to treat serious medical conditions through
its proprietary LATTM (Ligand Activated Therapy) platform
technology. KemPharm utilizes its proprietary LATTM platform
technology to generate improved prodrug versions of FDA-approved
drugs in the high need areas of ADHD, pain and other central
nervous system disorders. KemPharm’s co-lead clinical development
product candidates are KP415 and KP484, both based on a prodrug of
methylphenidate, but with differing extended-release/effect
profiles for the treatment of ADHD. In addition, the company
is advancing Apadaz™, an immediate-release combination product
candidate of benzhydrocodone, a prodrug of hydrocodone, and
acetaminophen, as well as KP201/IR, an acetaminophen-free
immediate-release formulation of the company’s benzhydrocodone.
Both Apadaz™ and KP201/IR are designed to deter abuse and are
intended for the treatment of acute pain severe enough to require
an opioid analgesic and for which alternative treatments are
inadequate. For more information on KemPharm and its pipeline of
prodrug product candidates visit www.kempharm.com.
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. These forward-looking statements include
statements regarding the expected features and characteristics of
KemPharm’s product candidates, including KP415, as well as the
expected timing of the completion of the pivotal efficacy trial for
KP415 and the expected timing of the NDA submission for KP415.
These forward-looking statements are not guarantees of future
actions or performance. These forward-looking statements are based
on information currently available to KemPharm and its current
plans or expectations, and are subject to a number of uncertainties
and risks that could significantly affect current plans. Actual
results and performance could differ materially from those
projected in the forward-looking statements as a result of many
factors, including, without limitation, the risks and uncertainties
associated with: KemPharm's financial resources and whether they
will be sufficient to meet KemPharm's business objectives and
operational requirements; results of earlier studies and trials may
not be predictive of future clinical trial results; the protection
and market exclusivity provided by KemPharm's intellectual
property; risks related to the drug discovery and the regulatory
approval process; the impact of competitive products and
technological changes; and the FDA approval process under the
Section 505(b)(2) regulatory pathway, including without limitation
any timelines for related approval. KemPharm's forward-looking
statements also involve assumptions that, if they prove incorrect,
would cause its results to differ materially from those expressed
or implied by such forward-looking statements. These and other
risks concerning KemPharm’s business are described in additional
detail in KemPharm's Quarterly Report on Form 10-Q for the quarter
ended September 30, 2017, filed with the Securities and Exchange
Commission on November 9, 2017, and KemPharm’s other Periodic and
Current Reports filed with the Securities and Exchange
Commission. KemPharm is under no obligation to (and expressly
disclaims any such obligation to) update or alter its
forward-looking statements, whether as a result of new information,
future events or otherwise.
Investor Contacts: |
Media Contact: |
Jason
Rando / Joshua Drumm, Ph.D.Tiberend Strategic Advisors,
Inc.212-375-2665 / 2664jrando@tiberend.comjdrumm@tiberend.com |
Daniel L. CohenExecutive VP, Government and Public
RelationsKemPharm, Inc.202-329-1825dcohen@kempharm.com |
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