KemPharm Files IND for KP415 for the Treatment of ADHD, An Investigational Prodrug of D-Threo-Methylphenidate
September 19 2016 - 7:03AM
KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty
pharmaceutical company focused on the discovery and development of
proprietary prodrugs, today announced 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 KP415,
the Company’s prodrug, extended release (ER)
d-threo-methylphenidate product candidate for the treatment of
attention deficit hyperactivity disorder (ADHD).
In preclinical studies of KP415, KemPharm
observed features that could provide significant benefits when
compared with other FDA-approved and widely prescribed
methylphenidate products. Pharmacokinetic data from those studies
suggest that the time to maximum plasma concentration of
methylphenidate after oral administration of KP415 is approximately
three times longer compared to immediate release (IR)
methylphenidate. KemPharm believes this ER attribute of
KP415’s molecular structure may allow for convenient, once-daily
dosing
“We are very excited to have the opportunity to
initiate clinical development of KP415, which we believe represents
KemPharm’s highest value pipeline candidate,” stated Travis C.
Mickle, Ph.D., President and Chief Executive Officer of
KemPharm. “KP415 has demonstrated both extended release
properties and a pharmacokinetic profile in pre-clinical studies
that, if validated in the next phase of clinical trials, would lead
to a more predictable therapy. This would be an important
advancement for the ADHD market.”
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 Ligand Activated Therapy (LAT) platform technology.
KemPharm utilizes its LAT platform technology to generate improved
prodrug versions of FDA-approved drugs in the high need areas of
pain, ADHD and other CNS (central nervous system)
disorders.
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 the expected development of 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 June
30, 2016, 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 |
KemPharm (NASDAQ:KMPH)
Historical Stock Chart
From Mar 2024 to Apr 2024
KemPharm (NASDAQ:KMPH)
Historical Stock Chart
From Apr 2023 to Apr 2024