UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Date of Report (Date of Earliest Event Reported):
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January 4, 2016
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Cytokinetics, Incorporated
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(Exact name of registrant as specified in its charter)
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Delaware
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000-50633
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94-3291317
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(State or other jurisdiction
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(Commission
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(I.R.S. Employer
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of incorporation)
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File Number)
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Identification No.)
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280 East Grand Avenue, South San Francisco, California
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94080
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(Address of principal executive offices)
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(Zip Code)
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Registrants telephone number, including area code:
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(650) 624 - 3000
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Not Applicable
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Former name or former address, if changed since last report
Check the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any
of the following provisions:
[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 8.01 Other Events.
On January 4, 2016 Cytokinetics, Inc. announced that its first Phase 2 clinical trial of CK-2127107, a novel fast skeletal muscle troponin activator, in patients with spinal muscular atrophy (SMA) has opened to enrollment. The clinical trial is designed to assess the effect of CK-2127107 on multiple measures of muscle function in both ambulatory and non-ambulatory patients with SMA, a severe, genetic neuromuscular disease that leads to debilitating muscle function and progressive, often fatal, muscle weakness. In collaboration with Astellas (Tokyo Stock Exchange: 4503, "Astellas"), Cytokinetics is developing CK-2127107 as a potential treatment for people living with SMA and certain other debilitating neuromuscular and non-neuromuscular diseases and conditions associated with skeletal muscle weakness and/or fatigue.
A copy of the press releases are filed as Exhibit 99.1 and 99.2 to this Current Report on Form 8-K, and is incorporated herein by reference.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
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Cytokinetics, Incorporated
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January 4, 2016
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By:
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/s/ Sharon A. Barbari
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Name: Sharon A. Barbari
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Title: Executive Vice President, Finance and Chief Financial Officer
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Exhibit Index
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Exhibit No.
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Description
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99.1
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Press Release, Dated January 4, 2016
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CYTOKINETICS ANNOUNCES START OF PHASE 2 CLINICAL TRIAL OF CK-2127107 IN PATIENTS WITH SPINAL
MUSCULAR ATROPHY
Company Initiates Phase 2 Program under Collaboration with Astellas
SOUTH SAN FRANCISCO, Calif. Jan 4, 2016 Cytokinetics, Inc. (Nasdaq: CYTK) today announced that
its first Phase 2 clinical trial of CK-2127107, a novel fast skeletal muscle troponin activator, in
patients with spinal muscular atrophy (SMA) has opened to enrollment. The clinical trial is
designed to assess the effect of CK-2127107 on multiple measures of muscle function in both
ambulatory and non-ambulatory patients with SMA, a severe, genetic neuromuscular disease that leads
to debilitating muscle function and progressive, often fatal, muscle weakness. In collaboration
with Astellas (Tokyo Stock Exchange: 4503, Astellas), Cytokinetics is developing CK-2127107 as a
potential treatment for people living with SMA and certain other debilitating neuromuscular and
non-neuromuscular diseases and conditions associated with skeletal muscle weakness and/or fatigue.
The primary objective of this double-blind, randomized, placebo-controlled clinical trial is to
determine the potential pharmacodynamic effects of a suspension formulation of CK-2127107 following
multiple oral doses in patients with Type II, Type III, or Type IV SMA. Secondary objectives are to
evaluate the safety, tolerability and pharmacokinetics of CK-2127107. The trial will enroll
seventy-two patients in two sequential, ascending dose cohorts (two cohorts of 36 patients each,
half ambulatory and half non-ambulatory). Each cohort will be stratified by ambulatory versus
non-ambulatory status to receive CK-2127107 dosed twice daily for 8 weeks.
Initiating this first Phase 2 trial of CK-2127107 represents a major step forward given our
interests to serve the many adolescents and adults who are living with SMA, a disorder with few
treatment options, said Robert I. Blum, Cytokinetics President and Chief Executive Officer. We
look forward to working closely with the investigators and clinical trial sites to evaluate the
effects of our next-generation skeletal muscle activator, which we believe holds promise for the
potential treatment of patients battling this devastating disease.
Clinical Trial Design
In this trial, both of the planned ascending dose cohorts will enroll 18 ambulatory (Type III or
Type IV) and 18 non-ambulatory patients (Type II or Type III) who are 12 years of age and older and
will randomize them 2:1 to receive CK-2127107 or placebo, stratified by ambulatory versus
non-ambulatory status. The first cohort of patients will receive 150 mg of CK-2127107 dosed twice
daily for eight weeks; the second cohort of patients will receive 450 mg of CK-2127107 dosed twice
daily or a lower dose, depending on the data from the first cohort. At the conclusion of the trial,
approximately 24 patients will have been randomized to placebo, approximately 24 patients to 150 mg
of CK-2127107 twice daily and approximately 24 patients to 450 mg of CK-2127107 twice daily (or a
lower dose, pending the review of data from the first cohort). Multiple assessments of skeletal
muscle function and fatigability will be 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. Additional information can be found at
clinicaltrials.gov.
About SMA
SMA is a severe neuromuscular disease that occurs in 1 in every 6,000 to 10,000 live births each
year and is one of the most common fatal genetic disorders. Spinal muscular atrophy manifests in
various degrees of severity as progressive muscle weakness resulting in respiratory and mobility
impairment. There are four types of SMA, named for age of initial onset of muscle weakness and
related symptoms: Type I (Infantile), Type II (Intermediate), Type III (Juvenile) and Type IV
(Adult onset). Life expectancy and disease severity vary by type of SMA. Type I patients have the
worst prognosis, with a life expectancy of no more than 2 years; Type IV patients have a normal
life span but eventually suffer gradual weakness in the proximal muscles of the extremities
resulting in mobility issues. Few treatment options exist for these patients, resulting in a high
unmet need for new therapeutic options to address symptoms and modify disease progression.
About CK-2127107
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.
Skeletal muscle myosin is the cytoskeletal motor protein that converts chemical energy into
mechanical force through its interaction with 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. CK-2127107, a novel skeletal muscle activator arising from
Cytokinetics skeletal muscle contractility program, 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 has demonstrated
pharmacological activity that may lead to new therapeutic options for diseases associated with
muscle weakness and fatigue. In non-clinical models of SMA, a skeletal muscle activator has
demonstrated increases in skeletal submaximal muscle force in response to neuronal input and delays
in the onset and reductions in the degree of muscle fatigue. CK-2127107 has been the subject of
five completed Phase 1 clinical trials in healthy volunteers, which evaluated safety, tolerability,
bioavailability, pharmacokinetics and pharmacodynamics.
About Cytokinetics and Astellas Collaboration
In 2013, Astellas and Cytokinetics formed a partnership focused on the research, development, and
commercialization of skeletal muscle activators. The primary objective of the collaboration is to
advance novel therapies for diseases and medical conditions associated with muscle impairment and
weakness. Under the collaboration, Cytokinetics exclusively licensed to Astellas the rights to
co-develop and potentially co-commercialize CK-2127107, a fast skeletal troponin activator, in
non-neuromuscular indications.
In 2014, Astellas and Cytokinetics agreed to expand the collaboration to include certain
neuromuscular indications, including SMA, and to advance CK-2127107 into Phase 2 clinical
development, initially in SMA. In connection with the expanded collaboration, the companies also
agreed to extend their joint research program through 2016. Under the amended collaboration,
Astellas has exclusive rights to co-develop and commercialize CK-2127107 and other fast skeletal
troponin activators in non-neuromuscular indications and certain neuromuscular indications
(including SMA) and other novel mechanism skeletal muscle activators in all indications, subject to
certain Cytokinetics development and commercialization rights; Cytokinetics may co-promote and
conduct certain commercial activities in North America and Europe under agreed scenarios.
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 lead drug
candidate is tirasemtiv, a fast skeletal muscle troponin activator, for the potential treatment of
ALS. Tirasemtiv 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 ALS. Cytokinetics retains the right to develop and commercialize
tirasemtiv. Cytokinetics is collaborating with Amgen Inc. to develop omecamtiv mecarbil, a novel
cardiac muscle activator, for the potential treatment of heart failure. Cytokinetics is
collaborating with Astellas Pharma Inc. to develop CK-2127107, a fast skeletal muscle activator,
for the potential treatment of spinal muscular atrophy. Amgen holds an exclusive license worldwide
to develop and commercialize omecamtiv mecarbil and Astellas holds an exclusive license worldwide
to develop and commercialize CK-2127107. Both licenses are subject to Cytokinetics specified
development and commercialization participation rights. For additional information about
Cytokinetics, visit http://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 Acts 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, enrollment and progress of the Phase 2 clinical trial of CK-2127107 in patients
with SMA; the significance and utility of preclinical study and clinical trial results; and the
properties and potential efficacy and safety profile of CK-2127107 and Cytokinetics other drug
candidates. Such statements are based on managements current expectations, but actual results may
differ materially due to various risks and uncertainties, including, but not limited to, further
clinical development of tirasemtiv in ALS patients will require significant additional funding, and
Cytokinetics may be unable to obtain such additional funding on acceptable terms, if at all; the
FDA and/or other regulatory authorities may not accept effects on slow vital capacity as a clinical
endpoint to support registration of tirasemtiv for the treatment of ALS; 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 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; Amgens and Astellas decisions
with respect to the design, initiation, conduct, timing and continuation of development activities
for omecamtiv mecarbil and CK-107, 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:
Cytokinetics
Diane Weiser
Vice President, Corporate Communications, Investor Relations
(650) 624-3060
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