Cytokinetics, Inc.: Cytokinetics Announces Initiation of Multiple Dose Phase I Clinical Trial of CK-2127107

Cytokinetics, Inc.: Cytokinetics Announces Initiation of Multiple Dose Phase I
                         Clinical Trial of CK-2127107

Commencement of Study Triggers Milestone Payment from Astellas
South San Francisco, CA, March 27, 2014 - Cytokinetics, Incorporated (Nasdaq:
CYTK) announced the initiation of an additional Phase I clinical trial of
CK-2127107, a fast skeletal muscle troponin activator. The trial, called
CY5012, is a double-blind, randomized, placebo-controlled, parallel group
study in which the primary objective is to assess the safety, tolerability,
and pharmacokinetics of CK-2127107 following multiple ascending doses in
healthy volunteers. The initiation of this clinical trial triggers a $2
million milestone payment from Astellas Pharma Inc. (Tokyo Stock Exchange:
4503, "Astellas") to Cytokinetics under the terms of the collaboration between
the companies established in June 2013. 
In CY 5012, volunteers in each ascending dose cohort will be randomized to
receive either CK-2127107 or placebo. CY 5012 will separately enroll cohorts
of volunteers in two age groups, one between the ages of 18 and 55 and one
between the ages of 65 and 85. Each cohort will be comprised of six male and
six female participants. In each cohort, volunteers will receive CK-2127107
or placebo in accordance with 2:1 randomization. An initial cohort in each
age group will receive 300 mg of CK-2127107 or placebo to be followed by a
second cohort in each age group that will receive 1000 mg of CK-2127107 or
placebo. Doses of CK-2127107 and placebo will be administered orally for 10
days. If these doses of CK-2127107 are well-tolerated, a final cohort of
volunteers between the ages of 18 and 55 will receive CK-2127107 at either
1500 mg or 2000 mg, to be determined following a review of data from the prior
dose cohorts or placebo. In each cohort, pharmacokinetic assessments will be
performed following the first dose of CK-2127107 and throughout the study to
day 10.  
"This multi-dose clinical trial of CK-2127107 is another in the series of
Phase I trials that Cytokinetics is conducting on behalf of the
collaboration," stated Fady Malik, MD, PhD, Cytokinetics' Senior Vice
President, Research and Early Development. "These studies along with other
Phase II readiness activities will inform the potential progression of
CK-2127107 into a Phase II development program focused on non-neuromuscular
indications." 
Development Status of CK-2127107
Cytokinetics previously reported the results of the first-time-in-humans
clinical trial of CK-2127107, called CY5011. This Phase I clinical trial was
a double-blind, randomized, placebo-controlled study designed to assess the
safety, tolerability, and pharmacokinetics of single ascending oral doses of
CK-2127107 administered to healthy adult males in a three-period, escalating
dose, crossover design. Planned single doses of CK-2127107 up to 4000 mg, the
highest dose administered in the trial, were well-tolerated; therefore, a
maximum tolerated dose could not be defined. The pharmacokinetic profile of
CK-2127107 was linear and dose-proportional across the dose range studied,
with a mean terminal half-life compatible with once or twice daily dosing. In
addition, Cytokinetics recently completed dosing in CY 5014, a Phase I
clinical trial of CK-2127107 in healthy male volunteers. CY 5014 is a
randomized, open-label, two-period crossover study designed to assess the
relative oral bioavailability, pharmacokinetics, safety and tolerability of
two oral formulations of CK-2127107.
Cytokinetics and Astellas Collaboration
CY 5012 is being conducted by Cytokinetics in collaboration with Astellas.
Cytokinetics and Astellas entered into a collaboration in June 2013 to
advance novel therapies, including CK-2127107, for diseases and medical
conditions associated with muscle weakness. Cytokinetics has exclusively
licensed to Astellas the rights to co-develop and commercialize CK-2127107 for
potential application in non-neuromuscular indications.  Cytokinetics is
primarily responsible for the conduct of Phase I clinical trials and certain
Phase II readiness activities for CK-2127107 and Astellas will be primarily
responsible for the conduct of subsequent development and commercialization
activities for CK-2127107. Cytokinetics and Astellas are jointly conducting
research in the area of skeletal muscle activation. Astellas has exclusive
rights to develop and commercialize other fast skeletal troponin activators in
non-neuromuscular indications and to develop and commercialize other novel
mechanism skeletal muscle activators in all indications, subject to certain
Cytokinetics' development and commercialization rights. Under the
collaboration, Cytokinetics is eligible to receive over $450 million in
pre-commercialization and commercialization milestones plus royalties.
Background on Skeletal Muscle Activators
Skeletal muscle contractility is driven by the sarcomere, the fundamental unit
of skeletal muscle contraction. It is a highly ordered cytoskeletal structure
composed of several key proteins. The first, skeletal muscle myosin, is the
cytoskeletal motor protein that converts chemical energy into mechanical force
through its interaction with a second protein, actin. A set of regulatory
proteins, which includes tropomyosin and several types of troponin, make the
actin-myosin interaction dependent on changes in intracellular calcium levels.
In non-clinical models, CK-2127107 slows the rate of calcium release from the
regulatory troponin complex of fast skeletal muscle fibers, which sensitizes
the sarcomere to calcium, leading to an increase in skeletal muscle
contractility. CK-2127107 and other skeletal sarcomere activators have
demonstrated pharmacological activity that may lead to new therapeutic options
for diseases associated with aging and muscle wasting. The clinical effects of
muscle wasting, fatigue and loss of mobility can range from decreased quality
of life to life-threatening complications. By directly improving skeletal
muscle function, a small molecule activator of the skeletal sarcomere may
potentially enhance physical performance and quality of life in patients with
conditions marked by muscle weakness and fatigue.
About Cytokinetics
Cytokinetics is a clinical-stage biopharmaceutical company focused on the
discovery and development of novel small molecule therapeutics that modulate
muscle function for the potential treatment of serious diseases and medical
conditions. Cytokinetics' lead drug candidate from its cardiac muscle
contractility program, omecamtiv mecarbil, is in Phase II clinical development
for the potential treatment of heart failure. Amgen Inc. holds an exclusive
license worldwide to develop and commercialize omecamtiv mecarbil and related
compounds, subject to Cytokinetics' specified development and
commercialization participation rights. Cytokinetics is independently
developing tirasemtiv, a fast skeletal muscle activator, as a potential
treatment for diseases and medical conditions associated with neuromuscular
dysfunction. Tirasemtiv is currently the subject of a Phase II clinical trials
program and has been granted orphan drug designation and fast track status by
the U.S. Food and Drug Administration and orphan medicinal product designation
by the European Medicines Agency for the potential treatment of amyotrophic
lateral sclerosis (ALS). Cytokinetics is collaborating with Astellas Pharma
Inc. to develop CK-2127107, a skeletal muscle activator structurally distinct
from tirasemtiv, for non-neuromuscular indications. All of these drug
candidates have arisen from Cytokinetics' muscle biology focused research
activities and are directed towards the cytoskeleton. The cytoskeleton is a
complex biological infrastructure that plays a fundamental role within every
human cell. Additional information about Cytokinetics can be obtained at
www.cytokinetics.com.
This press release contains forward-looking statements for purposes of the
Private Securities Litigation Reform Act of 1995 (the "Act"). Cytokinetics
disclaims any intent or obligation to update these forward-looking statements,
and claims the protection of the Act's Safe Harbor for forward-looking
statements. Examples of such statements include, but are not limited to,
statements relating to Cytokinetics' and its partners' research and
development activities, including the conduct, design and results of clinical
trials, the significance and utility of preclinical data and clinical trial
results, and the properties and potential benefits of Cytokinetics' skeletal
muscle activators, including CK-2127107, and other drug candidates; and the
expected roles of Cytokinetics and Astellas under their collaboration. Such
statements are based on management's current expectations, but actual results
may differ materially due to various risks and uncertainties, including, but
not limited to, Cytokinetics anticipates that it will be required to conduct
at least one confirmatory Phase III clinical trial of tirasemtiv in ALS
patients which will require significant additional funding, and it may be
unable to obtain such additional funding on acceptable terms, if at all;
potential difficulties or delays in the development, testing, regulatory
approvals for trial commencement, progression or product sale or
manufacturing, or production of Cytokinetics' drug candidates that could slow
or prevent clinical development or product approval, including risks that
current and past results of clinical trials or preclinical studies may not be
indicative of future clinical trials results, patient enrollment for or
conduct of clinical trials may be difficult or delayed, Cytokinetics' drug
candidates may have adverse side effects or inadequate therapeutic efficacy,
the U.S. Food and Drug Administration or foreign regulatory agencies may delay
or limit Cytokinetics' or its partners' ability to conduct clinical trials,
and Cytokinetics may be unable to obtain or maintain patent or trade secret
protection for its intellectual property; Astellas' and Amgen's decisions with
respect to the design, initiation, conduct, timing and continuation of
development activities for CK-2127107 and omecamtiv mecarbil, respectively;
Cytokinetics may incur unanticipated research and development and other costs
or be unable to obtain additional financing necessary to conduct development
of its products; Cytokinetics may be unable to enter into future collaboration
agreements for its drug candidates and programs on acceptable terms, if at
all; standards of care may change, rendering Cytokinetics' drug candidates
obsolete; competitive products or alternative therapies may be developed by
others for the treatment of indications Cytokinetics' drug candidates and
potential drug candidates may target; and risks and uncertainties relating to
the timing and receipt of payments from its partners, including milestones and
royalties on future potential product sales under Cytokinetics' collaboration
agreements with such partners. For further information regarding these and
other risks related to Cytokinetics' business, investors should consult
Cytokinetics' filings with the Securities and Exchange Commission.
Contact:
Joanna L. Goldstein
Manager, Corporate Communications & Marketing
(650) 624-3000

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Source: Cytokinetics, Inc. via Globenewswire
HUG#1772084
 
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