Statistically significant pharmacokinetic and
pharmacodynamic differences of abuse potential were observed in the
KP511.A01 Study
KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty
pharmaceutical company focused on the discovery and development of
proprietary prodrugs, today announced the results of its
exploratory Phase 1, double-blind, single-dose, 2-treatment,
2-period, randomized, crossover study (Study KP511.A01) intended to
assess the pharmacokinetics, safety and intranasal abuse potential
of KP511 Active Pharmaceutical Ingredient (API) compared to
equivalent doses of hydromorphone hydrochloride (HM API). KP511 is
KemPharm’s investigational prodrug of hydromorphone for the
treatment of pain. The results of the study indicated that
KP511 demonstrated statistically significant reduction in peak and
overall hydromorphone exposure with KP511 API versus HM API. The
improved pharmacokinetics of KP511 resulted in meaningful,
statistically lower scores in the exploratory pharmacodynamic
measures of “Drug Liking,” “Feeling High,” “Overall Drug Liking”
and “Take Drug Again” when compared to HM API.
“This study provides very strong preliminary
evidence that KP511 imparts significant potential for deterring
intranasal abuse when compared to currently marketed hydromorphone
products,” said Lynn Webster MD, Vice President Scientific Affairs,
PRA Health Sciences, Salt Lake City Utah, following an independent
review of the Study results. “While the promising results of this
exploratory study will need to be confirmed in a pivotal intranasal
human abuse potential study, they show that KP511 may provide
improvement across multiple abuse measures relative to
hydromorphone. It was particularly important to see that the ‘Take
Drug Again’ endpoint was significantly lower with KP511. The ‘Take
Drug Again’ measure plays an important role in the premarket
assessment of abuse deterrent technologies for predicting their
performance in the real world. The current data suggest that KP511
may be less likely snorted, which could be a potential public
health benefit.”
“We are pleased with the results of the Phase 1
study of KP511, which demonstrated that KP511 may, if the results
are confirmed, provide clinically meaningful differences in
intranasal abuse potential versus hydromorphone. If confirmed, this
may give us the option to develop KP511 as an extended-release and
immediate-release product candidate, and, if approved, could
potentially provide an effective therapy to pain patients and offer
a new hydromorphone product with meaningful abuse-deterrent
properties,” stated Travis C. Mickle, Ph.D., President and Chief
Executive Officer of KemPharm. “The decrease in mean peak
hydromorphone exposure by approximately 63% combined with the delay
of 30 minutes in time to peak exposure translated into significant
reduction in ‘Drug Liking,’ ‘Feeling High,’ ‘Overall Drug Liking’
and ‘Take Drug Again’ scores.”
“Given the magnitude of the potential benefit,
we intend to develop both an extended release (ER) and an immediate
release (IR) version of KP511. The next phase in the
development of KP511 is the completion of pivotal studies over the
next two years, leading to potentially two New Drug Applications
(NDAs) being submitted as early as 2019 with anticipated expedited
review,” added Travis. “Based on our estimates, in 2015, the
combined ER and IR market for hydromorphone was more than $280
million, with over 3.2 million scripts written in that year.
A market this large requires products with effective abuse
deterrence.”
Summary of the Preliminary Results from
Study KP511.A01.
Study KP511.A01 was a Phase 1, double-blind,
single-dose, 2-treatment, 2-period, randomized, crossover study
intended to assess the pharmacokinetics, safety and exploratory
intranasal abuse potential of KP511 API compared to hydromorphone
API after intranasal administration in twenty-six nondependent
recreational opioid users who reported prior insufflation
experience. The primary endpoint was pharmacokinetic evaluation of
hydromorphone released from KP511 API and HM API. The secondary
endpoint was safety. The exploratory endpoint was the intranasal
abuse potential.
Mean peak hydromorphone exposure (Cmax) was
reduced by approximately 63% and median Tmax for hydromorphone was
delayed by 30 minutes after insufflation of KP511 API when compared
to HM API. Mean overall hydromorphone exposure with KP511 API was
approximately 58% and 48% lower as measured by AUClast and AUCinf,
respectively. In addition, mean cumulative hydromorphone exposures
at time points following intranasal administration of KP511 were
decreased from approximately 56% to 100% (higher reduction at
earlier time points) with negligible hydromorphone plasma
concentration prior to the 30-minute time point. The results
demonstrated that KP511 prodrug may release hydromorphone at a
significantly slower rate and lower extent after intranasal
administration when compared to HM API. KemPharm believes the
statistically significant reduction in hydromorphone exposure
translated into statistically significant differences in the
exploratory pharmacodynamic measures. Mean maximum scores (Emax) of
“Drug Liking” and “Feeling High” for KP511 were approximately 11.4
and 23.4 points lower, respectively. Additionally, mean “Overall
Drug Liking” and “Take Drug Again” scores collected at
24 hours post-dose were approximately 16.0 and 13.3 points
lower, respectively. Abuse measures were assessed on bipolar and
unipolar (“Feeling High” only) visual analog scales.
In a retrospective assessment of drug preference
after the last treatment, a significant majority of subjects (17
out of 26) preferred HM API over KP511 API indicating that KP511
may be less attractive for intranasal abuse. Several endpoints
related to intranasal irritation including nasal burning, need to
blow nose, nasal discharge and facial pain were higher (i.e., more
severe) for KP511 versus HM API.
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 U.S. Food and Drug Administration
(FDA)-approved drugs in the high need areas of pain, attention
deficit hyperactivity disorder (ADHD) and other central nervous
system (CNS) disorders. KemPharm’s co-lead clinical development
candidates are KP415, an ER prodrug of methylphenidate for the
treatment of ADHD, and KP201/IR, an acetaminophen (APAP)-free
formulation of the company’s immediate release (IR) abuse deterrent
hydrocodone product, 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, characteristics,
development timeline and potential submission of NDAs for KP511/ER
and KP511/IR. 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 KP511/ER or KP511/IR; 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 quarter
ended September 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:
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
KemPharm (NASDAQ:KMPH)
Historical Stock Chart
From Mar 2024 to Apr 2024
KemPharm (NASDAQ:KMPH)
Historical Stock Chart
From Apr 2023 to Apr 2024