SARASOTA, Fla., Aug. 10,
2015 /PRNewswire/ -- Rock Creek Pharmaceuticals, Inc.,
(NASDAQ: RCPI), a clinical stage, drug development company which
has focused on the application of its lead compound to chronic
inflammatory conditions, announced today its second quarter
results. The Company also disclosed its dermatological development
program in which dermal formulations of its lead compound are being
developed for common chronic skin disorders such as psoriasis,
eczema (e.g., atopic dermatitis) and rare or orphan skin disorders.
Patients and key opinion leaders agree there are unmet medical
needs requiring new, safe and effective first-line treatments for
dermatological diseases, and the Company believes the novel
anti-inflammatory mechanism of action of its lead compound is well
suited to meet these needs. The Company is directing its strategy
to gain regulatory approval accordingly.
Clinical/Regulatory Strategy
Rock Creek Pharmaceuticals has an extensive array of published
and non-published preclinical and clinical data which provides
compelling evidence that Anatabine Citrate produces
anti-inflammatory effects through a unique mechanism of action
distinct from steroids, non-steroidal anti-inflammatories, and
biologics. Included in such data is the Company's recently
reported results from a small pharmacodynamic human trial in a
July 1, 2015 press release, entitled
"Rock Creek Pharmaceuticals Reports Human Proof of
Principle Study of Lead Compound Demonstrating Inhibition of
Inflammatory Markers In White Blood Cells".
Results from that study showed a statistically significant
(p<0.05) reduction in pro-inflammatory protein activation (NF-kB
and STAT3) in LPS challenged white blood cells from 10 healthy
volunteers after a single oral dose of Anatabine Citrate, with no
safety concerns raised by the investigators.
The Company recently reported initial results of "Part
One" of the Phase I clinical study being conducted
in the United Kingdom (UK) to
evaluate the safety, tolerability, and pharmacokinetic (PK)
profiles of various modified and immediate release oral
formulations of Anatabine Citrate. In Part One, there
were no reports of serious adverse events (AEs) or AEs leading to
study withdrawal, and there were no safety concerns raised by
either the Company's UK contract research organization or its UK
based medical monitor for the trial. The Company further announced
it would conduct "Part Two", with a
protocol amendment that primarily evaluates the effects
of food on PK parameters, with dosing expected to
commence and be completed within the current quarter 2015. The UK's
Medicine and Healthcare products Regulatory Agency (MHRA) and an
independent Research Ethics Committee approved the protocol
amendment. The Company's previously announced "Part
Three", double-blind, placebo-controlled, seven-day
multiple dose study of Anatabine Citrate in healthy subjects, will
likely overlap with "Part Two" and is
expected to be completed with preliminary results in the third
quarter 2015.
In light of the Company's ongoing clinical advances in
Europe and the generation of oral
phase I safety data, the Company has carefully evaluated its
regulatory strategy in the United
States. As indicated in a Form 8-K filing on April 2, 2015, the Company has remained on an
FDA-imposed clinical hold for an oral phase I safety study. Because
the US IND Phase I, first-in-human, single ascending dose PK
protocol is essentially encompassed by the ongoing MHRA approved,
European Phase I safety trial, which is nearing completion, the
Company has decided to withdraw its current US IND submission. The
Company believes this strategy will provide a pathway for
subsequent clinical and regulatory development in the United States as the Company accumulates
human safety and efficacy data in its EU dermatological
developmental program.
Scientific Research Update
The transcription factors, NF-κB and STAT3, are known causative
regulators of inflammation and are regarded as therapeutic targets
in certain dermatological conditions including psoriasis. Our lead
compound attenuates the activity of these factors in a variety of
experimental conditions and is therefore suited to targeting
dermatological disorders where NF-κB and STAT3 activity is
increased. Given other advantages of dermatological trial designs
and timelines, the Company is formulating Anatabine Citrate for
clinical trials of human inflammatory skin diseases. The Company
has been unifying its scientific, clinical, regulatory and
consultancy resources to plan a Phase IB, proof-of-concept trial
with patients diagnosed with mild to moderate psoriasis in
Europe, which is expected to
commence in the first quarter of 2016.
Second Quarter 2015 Results
The Company recorded a net loss of approximately $0.8 million for the three months ended
June 30, 2015, compared to a net loss
of approximately $12.7 million, a
decrease of approximately $11.9
million attributed primarily to the cost savings from the
restructuring, a decrease in non-cash expenditures and a gain on
derivatives.
General and administrative expenses were approximately
$1.6 million for the three months
ended June 30, 2015 compared to
approximately $11.2 million for the
comparable period in 2014, a decrease of $9.6 million or 85.7%. The expense
reductions were attributed to a $1.7
million decrease in legal expenses as a result of the
completion of the Department of Justice (DOJ) investigation and
settlement of the securities class action litigation; a decrease in
non-cash charges of $3.7 million
related to stock based compensation over the same period in the
prior year; a reduction of approximately $4.1 million as compared to the three months
ended June 30, 2014 due to the
completion of the 2014 restructuring. This restructuring
consolidated all of the Company's offices into one and
substantially reduced the number of employees, thus lowering
payroll and related expenses, reducing rent expense, and lowering
administrative operating expenses such as travel and
communication.
The Company invested approximately $0.4
million on research and development in the three months
ended June 30, 2015 compared to
approximately $0.8 million in the
comparable period in 2014. The research and development costs
in the three months ended June 30,
2015 were directed principally toward generating preclinical
data, testing safety in the human phase I trial and formulating
dermatological preparations of the Company's lead compound.
Dr. Michael Mullan, (MBBS, PhD),
Chairman and Chief Executive Officer of Rock Creek Pharmaceuticals,
remarked, "We are pleased to be executing our clinical development
plan, gathering the necessary human safety data in healthy
volunteer subjects prior to studies in patients suffering from
dermatological conditions. Additional preclinical data continue to
affirm the novel anti-inflammatory mechanism of action of the lead
compound which we seek to harness for the benefit of patients. It
is also of importance that we have managed to effect a major
corporate restructuring which has resulted in substantial cost
savings and an overall repositioning of the Company in preparation
for the next steps in clinical development."
About Anatabine Citrate:
Rock Creek Pharmaceuticals' compound is a small molecule,
cholinergic agonist which exhibits anti-inflammatory
pharmacological characteristics, distinct from other
anti-inflammatory drugs available such as biologics, steroids and
non-steroidal anti-inflammatories. The Company has sponsored
extensive pre-clinical (in vitro and in vivo) studies resulting in
peer reviewed and published scientific journal articles, covering
models of Multiple Sclerosis, Alzheimer's Disease, and Auto-Immune
Thyroiditis. All these studies demonstrated the anti-inflammatory
effects of the Company's compound. In addition, the Company's
compilation of human exposure, safety and tolerability data,
derived primarily from human clinical studies and post-marketing
data collection of the previously marketed nutraceutical product,
has provided important insights for clinical development.
About Rock Creek Pharmaceuticals, Inc.:
Rock Creek Pharmaceuticals, Inc. is an emerging drug development
company focused on the discovery, development and commercialization
of new drugs, formulations and compounds that provide therapies for
chronic and acute inflammatory diseases and neurologic
disorders.
For more information, visit:
http://www.rockcreekpharmaceuticals.com
Forward Looking Statements:
Certain statements contained in this release constitute
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. Such statements include,
but are not limited to statements identified by words such as
"believes," "expects," "anticipates," "estimates," "intends,"
"plans," "targets," "projects" and similar expressions. The
statements in this release are based upon the current beliefs and
expectations of our company's management and are subject to
significant risks and uncertainties. Actual results may differ from
those set forth in the forward-looking statements. Numerous factors
could cause or contribute to such differences, including, but not
limited to, failure to obtain sufficient capital resources to fund
our development program and operations, results of clinical trials
and/or other studies, the challenges inherent in new product
development initiatives, including the continued development and
approval of anti-inflammatory drug candidates, the effect of any
competitive products, our ability to license and protect our
intellectual property, our significant payables, our ability to
raise additional capital in the future that is necessary to
maintain our business, changes in government policy and/or
regulation, potential litigation by or against us, any governmental
review of our products or practices, pending litigation matters, as
well as other risks discussed from time to time in our filings with
the Securities and Exchange Commission, including, without
limitation, our annual report on Form 10-K for the fiscal year
ended December 31, 2014 filed on
March 12, 2015. We undertake no duty
to update any forward-looking statement or any information
contained in this press release or in other public disclosures at
any time.
CONTACT:
Ted Jenkins
Vice President, Corporate Strategy & Development
Rock Creek Pharmaceuticals
2040 Whitfield Avenue, Suite 300
Sarasota, FL 34243
Direct: 941-251-0488
tjenkins@rockcreekpharmaceuticals.com
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SOURCE Rock Creek Pharmaceuticals, Inc.