Cytokinetics Announces Progress Against Vision 2020
January 03 2018 - 7:30AM
Multiple Clinical Trials Advance Under
Collaborations with Astellas and Amgen
Cytokinetics, Incorporated (Nasdaq:CYTK) today announced progress
against its Vision 2020 initiatives designed to advance and expand
its pipeline of muscle biology directed drug candidates in
late-stage development to address urgent needs of people living
with conditions characterized by impaired muscle function and
weakness.
“We are continuing to execute against our Vision
2020 strategy with expected results from four mid-stage clinical
trials of CK-2127107 under our collaboration with Astellas and the
continued enrollment of patients with chronic heart failure in
GALACTIC-HF under our collaboration with Amgen,” said Robert I.
Blum, Cytokinetics’ President & CEO. “In parallel, our research
continues to power innovation in 2018 as we are advancing three
potential drug candidates to development.”
CK-2127107: Results from Four
Trials Expected in 2018 Under Collaboration with
Astellas
CK-2127107 is the subject of four mid-stage
clinical trials enrolling patients in both neuromuscular and
non-neuromuscular diseases or conditions in which impaired muscle
function and weakness play a meaningful role. These include Phase 2
clinical trials in patients with spinal muscular atrophy (SMA),
chronic obstructive pulmonary disease (COPD) and amyotrophic
lateral sclerosis (ALS) and a Phase 1b clinical trial in elderly
adults with limited mobility or frailty.
- Cytokinetics is conducting a Phase 2 double-blind, randomized,
placebo-controlled clinical trial in patients with SMA which is
designed to determine potential pharmacodynamic effects of a
suspension formulation of CK-2127107 following 8 weeks of oral
dosing in each of two cohorts of 36 patients with Type II, Type
III, or Type IV disease. Secondary objectives are to evaluate the
safety, tolerability and pharmacokinetics of CK-2127107. There is
no single primary endpoint in this hypothesis-generating trial.
Multiple assessments of skeletal muscle function and fatigability
are being performed, including respiratory assessments, upper limb
strength and functionality for non-ambulatory patients, as well as
six-minute walk and timed-up-and-go for ambulatory
patients. Patients enrolled in the second cohort will also be
assessed with the SMA Health Index, a patient reported outcome
measure.
- Astellas is conducting a Phase 2 clinical trial which is
designed to assess the effect of CK-2127107 compared to placebo on
exercise tolerance in approximately 40 patients with COPD.
Additionally, the trial will assess cardiopulmonary and
neuromuscular effects of CK-2127107 relative to placebo and the
effect of CK-2127107 on resting spirometry relative to placebo. In
addition, the safety, tolerability and pharmacokinetics of
CK-2127107 will be assessed.
- Astellas is conducting a Phase 1b clinical trial which is
designed to assess the effect of CK-2127107 on skeletal muscle
fatigue in approximately 60 subjects who are 70 to 89 years of age
and who have limited mobility. Endpoints to be measured include the
change from baseline versus 14 days of treatment in sum of peak
torque during isokinetic knee extensions. Additionally, the trial
will assess the effects of CK-2127107 on physical performance as
well as assess the safety, tolerability and pharmacokinetics of
CK-2127107.
- Cytokinetics is conducting FORTITUDE-ALS
(Functional Outcomes in a
Randomized Trial of
Investigational Treatment with
CK-2127107 to Understand Decline
in Endpoints – in ALS) which is
expected to enroll 450 patients with ALS and is designed to assess
the change from baseline in the percent predicted slow vital
capacity (SVC) and other measures of skeletal muscle function after
12 weeks of treatment with CK-2127107. Secondary endpoints include
the slope of the change from baseline in the mega-score of muscle
strength measured by hand held dynamometry (HHD) and handgrip
dynamometry in patients on CK-2127107; change from baseline in the
ALS Functional Rating Scale – Revised (ALSFRS-R); incidence and
severity of treatment-emergent adverse events (TEAEs); and plasma
concentrations of CK-2127107 at sampled time points in the
trial.
Astellas
has exclusive rights to co-develop and commercialize CK-2127107 in
non-neuromuscular indications and neuromuscular indications,
subject to Cytokinetics’ development and commercialization rights.
Under the terms of the collaboration, all four trials of CK-2127107
are being funded by Astellas; results are expected in 2018.
Cytokinetics is eligible for milestone payments and royalties on
sales based on the further development and commercialization of
CK-2127107. Additional information regarding these trials can
be found at www.clinicaltrials.gov.
Omecamtiv Mecarbil:
Enrollment of Patients in GALACTIC-HF is on Track in
2018
Amgen is conducting GALACTIC-HF
(Global Approach to
Lowering Adverse
Cardiac Outcomes Through
Improving Contractility in
Heart Failure), the Phase 3
cardiovascular outcomes trial of omecamtiv mecarbil, in
collaboration with Cytokinetics. GALACTIC-HF is on schedule.
GALACTIC-HF is planned to enroll approximately 8,000 symptomatic
chronic heart failure patients in over 900 sites in 35 countries
who are either currently hospitalized for a primary reason of heart
failure or have had a hospitalization or admission to an emergency
room for heart failure within one year prior to screening. The
primary endpoint is a composite of time to cardiovascular death or
first heart failure event, which is defined as either a
hospitalization for heart failure or other urgent treatment for
worsening heart failure. Secondary endpoints include time to
cardiovascular death; patient reported outcomes as measured by the
Kansas City Cardiomyopathy Questionnaire Total Symptom Score; time
to first heart failure hospitalization; and all-cause death.
Additional information regarding GALACTIC-HF can be found
at www.clinicaltrials.gov.
The companies will also continue collaborating
in 2018 to finalize plans for the second Phase 3 trial of omecamtiv
mecarbil which is intended to evaluate its potential to increase
exercise performance and, potentially, its ability to reverse the
progressive enlargement of the heart in patients with heart
failure.
Amgen holds an exclusive, worldwide license to
omecamtiv mecarbil subject to Cytokinetics’ specified development
and commercialization rights. Amgen has granted a sublicense to
Servier to commercialize omecamtiv mecarbil in Europe, as well as
the Commonwealth of Independent States, including Russia. Under the
terms of the collaboration, Cytokinetics is eligible to receive
milestone payments and royalties on sales of omecamtiv
mecarbil.
Pipeline Expands with Three Potential
Drug Candidates Proceeding to Development in 2018
Three new muscle biology directed compounds are
advancing from research to development in 2018. Under our
collaboration with Amgen, a next-generation cardiac muscle
activator has recently been nominated as a development candidate by
the Joint Research Committee. This milestone triggered a $1 million
payment from Amgen to Cytokinetics. Under our collaboration with
Astellas, a next-generation skeletal muscle activator was recently
nominated as a development candidate, and the joint research
program has been extended through 2019. In addition, Cytokinetics
is advancing an unpartnered cardiac sarcomere directed compound
from research into IND-enabling studies in 2018.
About Cytokinetics
Cytokinetics is a late-stage biopharmaceutical
company focused on discovering, developing and commercializing
first-in-class muscle activators as potential treatments for
debilitating diseases in which muscle performance is compromised
and/or declining. As a leader in muscle biology and the mechanics
of muscle performance, the company is developing small molecule
drug candidates specifically engineered to increase muscle function
and contractility. Cytokinetics is collaborating with Amgen Inc.
(“Amgen”) to develop omecamtiv mecarbil, a novel cardiac muscle
activator. Omecamtiv mecarbil is the subject of GALACTIC-HF, an
international Phase 3 clinical trial in patients with heart
failure. Amgen holds an exclusive worldwide license to develop and
commercialize omecamtiv mecarbil with a sublicense held by Servier
for commercialization in Europe and certain other countries.
Cytokinetics is collaborating with Astellas Pharma Inc.
(“Astellas”) to develop CK-2127107, a next-generation FSTA.
CK-2127107 has been granted orphan drug designation by the FDA for
the potential treatment of SMA. CK-2127107 is the subject of three
ongoing Phase 2 clinical trials enrolling patients with spinal
muscular atrophy, chronic obstructive pulmonary disease and ALS.
Astellas is also conducting a Phase 1b clinical trial of CK-2127107
in elderly adults with limited mobility. Astellas holds an
exclusive worldwide license to develop and commercialize
CK-2127107. Licenses held by Amgen and Astellas are subject to
Cytokinetics' specified co-development and co-commercialization
rights. For additional information about Cytokinetics, visit
www.cytokinetics.com.
Forward-Looking Statements
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; the design, timing, results,
significance and utility of preclinical and clinical results,
including Cytokinetics’ expectations regarding the timing or
results from its clinical trials of CK-2127107, enrollment of
patients in GALACTIC-HF and pipeline expansion in 2018; and the
properties and potential benefits of CK-2127107 and Cytokinetics’
other drug candidates. 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, 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 trial 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 FDA 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’ decisions with respect to the
design, initiation, conduct, timing and continuation of development
activities for CK-2127107; Amgen’s decisions with respect to the
design, initiation, conduct, timing and continuation of development
activities for omecamtiv mecarbil; Cytokinetics may incur
unanticipated research and development and other costs or be unable
to obtain additional financing necessary to conduct development of
its products; 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:CytokineticsDiane WeiserVice President, Corporate
Communications, Investor Relations(415) 290-7757
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