KemPharm Enhances Pipeline with the Addition of KP879, a Potential New Treatment for Stimulant Use Disorder
November 13 2018 - 7:30AM
KP879 is being developed with
serdexmethylphenidate, KemPharm’s prodrug of d-methylphenidate, to
address a critical unmet need in the treatment of problematic
stimulant abuse
KemPharm, Inc. (NASDAQ:KMPH), a specialty pharmaceutical company
focused on the discovery and development of proprietary prodrugs,
today announced the addition of a new product candidate, KP879,
which the company plans to develop as an extended-duration, agonist
replacement therapy for the treatment of Stimulant Use Disorder
(SUD). Based on current timelines, KemPharm expects to file an
Investigational New Drug (IND) application with the U.S. Food and
Drug Administration (FDA) for KP879 as early as the end of 2018. To
date, there are no FDA-approved medications for the treatment of
SUD.
KP879 utilizes serdexmethylphenidate (SDX),
KemPharm’s prodrug of d-methylphenidate (d-MPH). SDX is also the
primary active pharmaceutical ingredient of KP415 and KP484, the
company’s co-lead clinical development product candidates which are
intended for the treatment of attention-deficit/hyperactivity
disorder (ADHD).
“Among the many potential drug therapies that
have been studied for the treatment of SUD, medications with CNS
stimulant-like properties have shown the most benefit,” said Andy
Barrett, Ph.D., Vice President of Scientific Affairs for KemPharm.
“It is believed that by enhancing dopamine signaling in key brain
areas, agonist replacement therapies may decrease craving and use
of illicit stimulants, promote restorative sleep, and increase
retention time of patients in substance abuse therapy. Prior
agonist replacement therapies have been limited in part by concerns
of their own abuse potential among the stimulant-abusing
population.”
“KP879 represents a significant development for
KemPharm as it adds a new product candidate to our pipeline that
could potentially address a significant unmet medical need. It also
shows that SDX has the potential to treat a number of CNS disorders
beyond ADHD,” said Travis Mickle, Ph.D., President and Chief
Executive Officer of KemPharm. “Based on information gathered
during the KP415 and KP484 development programs, we recognized that
SDX has pharmacokinetic properties that are desirable as an agonist
replacement therapy for the treatment of SUD. Specifically, we
observed that SDX provided a gradual onset followed by long
duration of d-MPH exposure, while also exhibiting the potential for
a reduction in abuse-related effects. Compared to current d-MPH
preparations when administered either orally at supratherapeutic
doses, intravenously or intranasally, SDX has already demonstrated
significantly reduced pharmacodynamic effects on multiple
abuse-related endpoints. Given these properties, we are advancing
KP879 to an IND submission as early as the end of 2018, and then
beginning clinical development for potentially the first-ever
approved pharmacotherapy for SUD.”
About Stimulant Use Disorder
(SUD):
Stimulant use disorders (SUDs) include those
marked by abuse/misuse of cocaine, methamphetamines, prescription
stimulant products that contain methylphenidate or amphetamine, and
numerous designer stimulants including, for example,
3,4-methylenedioxypyrovalerone (MDPV) and 4-methylmethcathinone
(mephedrone) (“bath salts”). According to the Substance Abuse and
Mental Health Services Administration (SAMHSA), in 2016, among
Americans older than 12 years, there were approximately 1.9 million
current users of cocaine, 667,000 users of methamphetamine, and 1.7
million current misusers of prescription stimulants. In the same
year, approximately 2.1 million Americans over 12 years of age had
SUD (defined as meeting DSM-IV criteria for abuse or
dependence).
Chronic misuse/abuse of stimulants can lead to a
constellation of health-related problems associated with chronic
constriction of blood vessels, including cardiovascular toxicity
(potentially leading to heart attack), cerebrovascular toxicity
(potentially leading to stroke), and gastrointestinal toxicity
(potentially leading to death of bowel tissue). Chronic stimulant
use can also lead to lowering of seizure thresholds, malnutrition,
and miscarriage in pregnant women. Long-term use of methamphetamine
has been shown to produce additional toxicities such as structural
brain abnormalities and neurotoxic effects (Courtney 2014).
Problematic stimulant use can also increase the risk of acquiring
blood-borne infections, either by direct contact with contaminated
needles or by engaging in risky sexual behaviors.
About KemPharm:
KemPharm is a specialty pharmaceutical company
focused on the discovery and development of proprietary prodrugs to
treat serious medical conditions through its proprietary LATTM
(Ligand Activated Therapy) technology. KemPharm utilizes its
proprietary LAT technology to generate improved prodrug versions of
FDA-approved drugs as well as to generate prodrug versions of
existing compounds that may have applications for new disease
indications. KemPharm’s product pipeline is focused on the high
need areas of ADHD, pain and other central nervous system
disorders. KemPharm’s co-lead clinical development candidates for
the treatment of ADHD, KP415 and KP484, are both based on a prodrug
of d-methylphenidate, but have differing extended-release/effect
profiles. In addition, KemPharm has received FDA approval for
APADAZ®, an immediate-release combination product containing
benzhydrocodone, a prodrug of hydrocodone, and acetaminophen. For
more information on KemPharm and its pipeline of prodrug product
candidates visit www.kempharm.com or connect with us on Twitter,
LinkedIn, Facebook and YouTube.
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 timeline for submitting an IND for KP879
and advancing KP879 into clinical development.
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. Risks
concerning KemPharm’s business are described in detail in
KemPharm’s Annual Report on Form 10-K for the year ended December
31, 2017, KemPharm’s Quarterly Report on Form 10-Q for the quarter
ended September 30, 2018, 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/Media Contacts: |
Jason
Rando / Joshua Drumm, Ph.D.Tiberend Strategic Advisors,
Inc.212-375-2665 / 2664jrando@tiberend.comjdrumm@tiberend.com |
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