KemPharm Files IND for KP484 for the Treatment of ADHD, An Investigational Prodrug of Methylphenidate
September 20 2017 - 7:30AM
KP484 Designed to be a Predictably Dosed,
Super-Extended Release, Methylphenidate Product
KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty
pharmaceutical company focused on the discovery and development of
proprietary prodrugs, announced today that it has filed an
Investigational New Drug (IND) application with the U.S. Food and
Drug Administration (FDA) to begin human clinical trials of KP484,
the Company’s prodrug product candidate of “super-extended” release
d-methylphenidate (d-MPH) for the treatment of attention deficit
hyperactivity disorder (ADHD).
“In the process of re-analyzing the Phase 1 data
for KP415, our co-lead investigation prodrug of d-MPH for the
treatment of ADHD, we observed properties and a drug release
profile in KP484 that we believe allows for the possible
development of a much longer acting form of the molecule that, if
approved, separate and apart from KP415, may enable us to target an
underserved group of ADHD patients,” said Travis C. Mickle, Ph.D.,
President and Chief Executive Officer of KemPharm. “We
believe both KP484 and KP415 have features that could provide
certain benefits when compared with other FDA-approved and widely
prescribed methylphenidate products. Pharmacokinetic data from our
studies suggest that the time to maximum plasma concentration of
our prodrug of methylphenidate after oral administration is
approximately three times longer compared to immediate release
methylphenidate, which may allow for convenient, once-daily
dosing.”
“Operationally designated KP484,” Dr. Mickle
continued, “the data observed suggests that the prodrug may produce
a longer duration release of d-MPH relative to comparator products
available on the market today. We believe this longer acting
property – or “Super-Extended Release” – may be well-suited for the
unique treatment needs of the adult ADHD population.”
KemPharm’s IND proposal is to develop KP484
along a similar clinical trial pathway as KP415, with efficacy
studies of KP484 initiating in 2018. It is anticipated that
data for KP484 will be leveraged from current and ongoing KP415
research, including pharmacokinetic and human abuse liability
studies, which could allow an expedited development timeline
towards a potential New Drug Application (NDA) submission with the
FDA as early as 2019. KemPharm believes that the ability to
develop multiple prodrugs from the same Active Pharmaceutical
Ingredient with unique treatment benefits and commercial profiles
is the hallmark of its Ligand Activated Therapy (LAT™) prodrug
discovery platform.
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 LATTM (Ligand Activated Therapy) platform technology.
KemPharm utilizes its LATTM platform technology to generate
improved prodrug versions of FDA-approved drugs in the high need
areas of pain, ADHD and other central nervous system disorders.
KemPharm’s co-lead clinical development candidates are KP415 and
KP484, both based on a prodrug of methylphenidate, but with
differing extended-release profiles for the treatment of ADHD, and
KP201/IR, an acetaminophen-free formulation of the company’s
immediate release abuse deterrent hydrocodone product candidate,
KP201. 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
KP415 and KP484, the expected timing of the initiation and
completion of clinical trials of KP415 and KP484, and the expected
timing for any submission of NDAs with the FDA for KP415 and KP484.
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 period
ended June 30, 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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