KemPharm Strengthens ADHD Prodrug Pipeline with Development of KP484, A New, Super-Extended Release ADHD Methylphenidate Prod...
June 28 2017 - 7:30AM
KP415 End-of-Phase 1 Meeting with FDA Affirms
KemPharm’s Development Plan and Potential NDA Submission as early
as late 2018
KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty
pharmaceutical company focused on the discovery and development of
proprietary prodrugs, today announced two significant advances
involving its prodrug development pipeline for the treatment of
attention deficit hyperactivity disorder (ADHD). These
advances include the development of a new prodrug product candidate
of d-threo-methylphenidate (d-MPH), KP484, for ADHD indications
that may benefit from a super-extended duration of treatment and
the successful completion of an End-of-Phase 1 (EOP1) meeting with
the U.S. Food and Drug Administration (FDA) for KP415.
KP484 – Prodrug of d-MPH for Super-Extended Duration
Treatment of ADHDKP484 is KemPharm’s newly developed
prodrug product candidate for a super-extended release (SER) d-MPH
being designed for the treatment of ADHD in patients that respond
best when a long duration of therapy beyond both KP415 and all
current methylphenidate treatments is required. The new
therapeutic application was developed during a data analysis of the
KP415 Phase 1 study, in which KemPharm observed that the prodrug
molecule demonstrated an ability to produce a longer duration
release of d-MPH relative to comparator products available on the
market today. As a result, KemPharm is now planning to
initiate development of KP484 and anticipates filing an
Investigational New Drug (IND) application for KP484 as early as
the third quarter of 2017. KemPharm expects to leverage data
from certain clinical and nonclinical trials of KP415 to expedite
the development of KP484. KemPharm believes that this may enable it
to realize key cost and R&D efficiencies and target a New Drug
Application (NDA) submission as soon as 2019.
KP415 – Prodrug of d-MPH for Treatment of ADHD with
Early On-set and Better Total DurationKP415 is KemPharm’s
extended release (ER) d-MPH prodrug product candidate designed for
the treatment of ADHD with patients that could benefit from both
earlier onset as well as better total duration of effect. As
previously indicated, KemPharm held an EOP1 meeting with the FDA to
discuss the data from the Phase 1 proof-of-concept clinical trial
of KP415 (KP415.101), additional nonclinical and manufacturing data
sets, and the proposed clinical and nonclinical programs required
for eventual submission of an NDA for KP415. Additionally,
KemPharm and the FDA discussed the proposed commercial formulation
of KP415, which KemPharm plans to develop with a layer of
methylphenidate to potentially support a superior early onset
profile. Based on the feedback from the FDA, KemPharm
believes that its ongoing and anticipated research of KP415,
including the pivotal efficacy trial, which KemPharm plans to
initiate in the second half of 2017, remains on schedule and in
alignment with an NDA submission as soon as late 2018.
KemPharm also anticipates that it will initiate a human abuse
liability (HAL) program of KP415 beginning in the second half of
2017 to assess the potential for the prodrug to deter intranasal,
intravenous and oral abuse. KemPharm expects data from the
HAL program and the ongoing pharmacokinetic (PK) studies will be
available in the second half of 2017 and early 2018. KemPharm
plans to utilize the data from both studies in the development
KP484, as well.
“We now believe KemPharm’s ADHD prodrug portfolio is the
company’s most valuable asset. In our view, the advances that we
have made with KP415 and our newly developed product candidate for
a super extended treatment, KP484, further support this belief,”
stated Travis C. Mickle, Ph.D., President and Chief Executive
Officer of KemPharm. “We continue to view KP415 as our
highest value product candidate, and we are excited to now take
this prodrug to the next phase of its development. Since our
quarterly update in May, we have initiated several pharmacokinetic
studies of KP415 with data from these studies expected during the
second half of 2017 and in early 2018. Now, following the
End-of-Phase 1 meeting with the FDA, we are prepared to develop the
commercial formulation of KP415 and initiate the pivotal efficacy
study and human abuse liability program for KP415 in the second
half of 2017; all pointing towards an NDA submission for KP415 as
soon as late 2018.”
“The success of our KP415 program is now heightened by the
development of a new product we are designating as KP484, which we
are planning to develop for patients that require a product that
provides a much longer duration of treatment for their ADHD,” Dr.
Mickle continued. “In contrast to Shire’s recently approved
amphetamine-based MYDAYISTM for extended duration of treatment for
ADHD, initial clinical data on KP484 suggest our new
methylphenidate product could offer substantially longer duration
when compared to other methylphenidate ADHD drugs which is clearly
an unmet need in treatment with methylphenidate. Given this, we
have now activated the development program for KP484 with our first
milestone being an IND filing in the third quarter.”
“We believe physicians need products, such as KP415 and KP484,
which are designed to provide solutions for their patients’
individual needs, recognizing that many may respond differently to
different treatments. Thus, it is important for patients to
have multiple treatment options,” Dr. Mickle concluded. “For
example, some patients need milder therapies such as a
methylphenidate-based option that may be just as effective and have
fewer side effects when compared to amphetamine-based
products.”
Conference Call
Information:
The company will host a conference call and live
audio webcast with slide presentation today, June 28, 2017, at 4:30
p.m. ET. Interested participants and investors may access the
conference call by dialing either:
- (866) 395-2480 (U.S.)
- (678) 509-7538 (international)
- Conference ID: 45888929
The live webcast with accompanying slides will
be accessible via the Investor Relations section of the KemPharm
website http://investors.kempharm.com/. An archive of the
webcast and presentation will remain available following the
call.
About KemPharmKemPharm 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, an extended-release prodrug of methylphenidate 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
StatementsThis 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, and the anticipated timelines for any IND or NDA
submission or the availability of clinical trial results.
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; obligations to third parties regarding the
potential commercialization or sale of KP415 or KP484; and the FDA
approval process, 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 March
31, 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:
Jason Rando / Joshua Drumm, Ph.D.
Tiberend Strategic Advisors, Inc.
212-375-2665 / 2664
jrando@tiberend.com
jdrumm@tiberend.com
Media Contact:
Daniel L. Cohen
Executive VP, Government and Public Relations
KemPharm, Inc.
202-329-1825
dcohen@kempharm.com
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