The purpose of this study is to assess the long-term safety and tolerability of tirasemtiv in patients with ALS who had completed the double-blind placebo-controlled study of tirasemtiv in ALS (CY 4031).

Start Date17 Oct 2016

Sponsor / Collaborator

Cytokinetics, Inc.

NCT02496767

/ CompletedPhase 3

A Phase 3, Multi-National, Double-Blind, Randomized, Placebo-Controlled, Stratified, Parallel Group, Study to Evaluate the Safety, Tolerability and Efficacy of Tirasemtiv in Patients With Amyotrophic Lateral Sclerosis (ALS)

This study assessed the effect of tirasemtiv versus placebo on respiratory function in patients with ALS.

Start Date03 Sep 2015

Sponsor / Collaborator

Cytokinetics, Inc.

NCT01709149

/ CompletedPhase 2

A Phase IIb, Multi-National, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS) (BENEFIT-ALS)

The purpose of this research study is to evaluate the safety and effectiveness of CK-2017357 when taken with or without riluzole (also called Rilutek®) in patients with Amyotrophic Lateral Sclerosis (ALS).

Start Date01 Oct 2012

Sponsor / Collaborator

Cytokinetics, Inc.

100 Clinical Results associated with Tirasemtiv

100 Translational Medicine associated with Tirasemtiv

100 Patents (Medical) associated with Tirasemtiv

Literatures (Medical) associated with Tirasemtiv

02 Jan 2025·Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration

Plasma neurofilament analysis in VITALITY-ALS

Article

Author: Rudnicki, Stacy A. ; Malik, Fady I. ; Meng, Lisa ; Bowser, Robert ; Shefner, Jeremy M. ; Simkins, Tyrell J. ; Wei, Jenny ; Kupfer, Stuart

OBJECTIVE:

To evaluate correlations between neurofilament (Nf) concentrations and clinical characteristics and disease progression using a large longitudinal dataset from VITALITY-ALS (ClinicalTrials.gov identifier: NCT02496767), a 48-week, randomized, double-blind, placebo-controlled clinical trial of tirasemtiv in people with ALS (pALS).

METHODS:

Plasma was collected at baseline and every 8 weeks thereafter. Results were compared between treatment groups and evaluated by clinical characteristics and over time. Pearson's correlation coefficients (r) were calculated to evaluate associations between Nf concentrations and slow vital capacity (SVC), Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) score, and pre-study/in-study rates of disease progression (psRDP/isRDP).

RESULTS:

Nf measurements were available from 101 placebo- and 161 tirasemtiv-treated people with ALS (pALS). There were no significant differences in Nf between placebo and tirasemtiv groups at any time point; further analyses grouped all samples. At baseline, Nf concentration did not differ by multiple clinical characteristics. Baseline Nf light chain (NfL) concentration correlated with the psRDP (r = 0.50, p < 0.001) and isRDP (r = 0.53, p < 0.0001). Phosphorylated Nf heavy chain (pNfH) demonstrated a similar, but less robust, pattern of results. Baseline Nf concentration correlated with change in SVC and ALSFRS-R score over time. Plasma pNfH concentration continuously decreased over time. There was no meaningful change in plasma NfL concentration over the study period.

CONCLUSIONS:

In this large longitudinal study, baseline NfL concentration correlated with multiple markers of disease progression. The findings suggest Nfs show promise primarily as prognostic markers for pALS, particularly for those with rapid disease progression.

01 Apr 2024·The Journal of general physiology

Tirasemtiv enhances submaximal muscle tension in an Acta1:p.Asp286Gly mouse model of nemaline myopathy

Article

Author: de Winter, Josine M ; Rossi, Maira ; Gondin, Julien ; Ottenheijm, Coen A C ; Malik, Fady I ; Pellegrino, Maria-Antonietta ; Hwee, Darren T ; Bottinelli, Roberto ; Gineste, Charlotte ; Borsboom, Tamara C ; Brocca, Lorenza ; Galli, Ricardo A

Nemaline myopathies are the most common form of congenital myopathies. Variants in ACTA1 (NEM3) comprise 15–25% of all nemaline myopathy cases. Patients harboring variants in ACTA1 present with a heterogeneous disease course characterized by stable or progressive muscle weakness and, in severe cases, respiratory failure and death. To date, no specific treatments are available. Since NEM3 is an actin-based thin filament disease, we tested the ability of tirasemtiv, a fast skeletal muscle troponin activator, to improve skeletal muscle function in a mouse model of NEM3, harboring the patient-based p.Asp286Gly variant in Acta1. Acute and long-term tirasemtiv treatment significantly increased muscle contractile capacity at submaximal stimulation frequencies in both fast-twitch extensor digitorum longus and gastrocnemius muscle, and intermediate-twitch diaphragm muscle in vitro and in vivo. Additionally, long-term tirasemtiv treatment in NEM3 mice resulted in a decreased respiratory rate with preserved minute volume, suggesting more efficient respiration. Altogether, our data support the therapeutic potential of fast skeletal muscle troponin activators in alleviating skeletal muscle weakness in a mouse model of NEM3 caused by the Acta1:p.Asp286Gly variant.

18 Mar 2023·International journal of molecular sciences

Molecular Mechanisms of Deregulation of Muscle Contractility Caused by the R168H Mutation in TPM3 and Its Attenuation by Therapeutic Agents.

Article

Author: Karpicheva, Olga E. ; Sirenko, Vladimir V. ; Redwood, Charles S. ; Avrova, Stanislava V. ; Borovikov, Yurii S. ; Bogdanov, Andrey L.

The substitution for Arg168His (R168H) in γ-tropomyosin (TPM3 gene, Tpm3.12 isoform) is associated with congenital muscle fiber type disproportion (CFTD) and muscle weakness. It is still unclear what molecular mechanisms underlie the muscle dysfunction seen in CFTD. The aim of this work was to study the effect of the R168H mutation in Tpm3.12 on the critical conformational changes that myosin, actin, troponin, and tropomyosin undergo during the ATPase cycle. We used polarized fluorescence microscopy and ghost muscle fibers containing regulated thin filaments and myosin heads (myosin subfragment-1) modified with the 1,5-IAEDANS fluorescent probe. Analysis of the data obtained revealed that a sequential interdependent conformational-functional rearrangement of tropomyosin, actin and myosin heads takes place when modeling the ATPase cycle in the presence of wild-type tropomyosin. A multistep shift of the tropomyosin strands from the outer to the inner domain of actin occurs during the transition from weak to strong binding of myosin to actin. Each tropomyosin position determines the corresponding balance between switched-on and switched-off actin monomers and between the strongly and weakly bound myosin heads. At low Ca²⁺, the R168H mutation was shown to switch some extra actin monomers on and increase the persistence length of tropomyosin, demonstrating the freezing of the R168HTpm strands close to the open position and disruption of the regulatory function of troponin. Instead of reducing the formation of strong bonds between myosin heads and F-actin, troponin activated it. However, at high Ca²⁺, troponin decreased the amount of strongly bound myosin heads instead of promoting their formation. Abnormally high sensitivity of thin filaments to Ca²⁺, inhibition of muscle fiber relaxation due to the appearance of the myosin heads strongly associated with F-actin, and distinct activation of the contractile system at submaximal concentrations of Ca²⁺ can lead to muscle inefficiency and weakness. Modulators of troponin (tirasemtiv and epigallocatechin-3-gallate) and myosin (omecamtiv mecarbil and 2,3-butanedione monoxime) have been shown to more or less attenuate the negative effects of the tropomyosin R168H mutant. Tirasemtiv and epigallocatechin-3-gallate may be used to prevent muscle dysfunction.

News (Medical) associated with Tirasemtiv

11 Mar 2025

·investor.regeneron.com

Regeneron Science Talent Search 2025 Awards More Than $1.8 Million to High School Seniors for Innovative Scientific Research on Classifying Objects in Space, Treating a Rare Muscle Disease and Solving a Long-Standing Math Problem

TARRYTOWN, N.Y. and WASHINGTON, March 11, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Society for Science (the Society) announced that Matteo Paz,18, of Pasadena, CA, won the top award of $250,000 in the 2025 Regeneron Science Talent Search, the U.S.’s oldest and most prestigious science and math competition for high school seniors. Now in its 84th year, the competition celebrates and rewards young innovators who are applying their Science, Technology, Engineering and Math (STEM) talent and leadership skills to push the boundaries of discovery and address today’s pressing challenges. Forty finalists, including Matteo, were honored this evening during an award ceremony at the National Building Museum in Washington, D.C, where they were awarded more than $1.8 million in prizes for their groundbreaking research, exceptional problem-solving skills and potential to shape the future of STEM. Matteo Paz, 18, of Pasadena, CA, won first place and $250,000 for designing machine-learning algorithms to efficiently comb through 200 billion entries of raw NEOWISE infrared full-sky data. By analyzing tiny changes in infrared radiation, the AI sorted the objects into 10 classes. He found 1.5 million new potential objects. Second place and $175,000 went to Ava Grace Cummings, 18, of Smithfield, NC, for creating a fruit fly model of STAC3 disorder, or Native American myopathy (a rare genetic muscle disease). She found that the common nettle herb, alone or combined with the experimental drug Tirasemtiv, improved movement in both adult flies and larvae. Third place and $150,000 went to Owen Jianwen Zhang, 18, of Bellevue, WA, for solving a long-standing math problem about objects called 3-uniform hypergraphs. He proved a maximum value for how many 3-uniform hypergraphs can have similar structures but differing connections. Owen's results have applications in computer science. "Congratulations to the winners of this year's Regeneron Science Talent Search," said Maya Ajmera, President and CEO, Society for Science and Executive Publisher, Science News. "The remarkable creativity and dedication of these students bring renewed hope for our future. Driven by their ingenuity, these young scientists are developing groundbreaking solutions that have the potential to transform our world and propel society forward." The Regeneron Science Talent Search provides a national platform for high school seniors to showcase original, innovative STEM research that proposes novel solutions to real-world issues. Finalists are evaluated for their scientific rigor, originality, critical thinking, leadership potential and commitment to drive meaningful impact across crucial STEM fields. “The Science Talent Search changed my life. At my high school, STS winners were treated like star athletes, and I never imagined I would belong in such an amazing group of kids who were operating at a whole different level than I had ever seen,” said George D. Yancopoulos, co-Founder, Board co-Chair, President and Chief Scientific Officer of Regeneron and a 1976 Science Talent Search finalist and top winner. “The experience of competing in STS and being named a top winner gave me the confidence to devote my life to science. So, congratulations to this year’s finalists and winners, you are America’s best and brightest. I hope this moment inspires you to push boundaries, challenge assumptions and use your brilliance to change the world.” Other top honors from the competition include: Fourth Place: Logan Lee, 18, of Honolulu, HI received a $100,000 award for helping sterile male mosquitoes survive in the wild. These males are important in mosquito control. Logan improved their survival by giving them a transplant of wild mosquito bacteria. His transplant helped the sterile mosquitoes grow faster and survive better in the wild. Fifth Place: Rivka Lipkovitz, 18, of San Francisco, CA received a $90,000 award for using statistical modeling to study U.S. voter ID laws. She found that presidential election turnout dropped by 2.4% in states that passed strict laws after 2008. Turnout for midterm elections increased. Knowing how laws affect turnout can help shape future policies. Sixth Place: Melody Heeju Hong, 17, of Wantagh, NY received a $80,000 award for developing a powerful, flexible statistical model for mapping sites called trans-methylation quantitative trait loci (trans-mQTL) within the human genome. These sites are key to understanding the interplay between genes and environment in disease and aging. Seventh Place: Kevin Shen, 18, of Olympia, WA received a $70,000 award for building a custom flight computer to control a 3D-printed airplane with oblique wings. These aircraft can be more fuel-efficient but are hard to control. His oblique-wing aircraft and flight computer improved flight efficiency by 9.2%. Eighth Place: Minghao Zou, 18, of Santa Clara, CA received a $60,000 award for simulating protons to probe environments that produce subatomic particles called neutrinos. He created an algorithm mimicking extreme astrophysical conditions, such as electromagnetic and gravitational forces and interactions with nearby particles. He verified it using known cases of particle motion. Ninth Place: Thanush Patlolla, 17, of Cary, NC received a $50,000 award for approximating the density of electrons using a finite nuclear model. Using a mathematical strategy called a density function, he created a model to map electrons in a nuclear simulation. The map increased the accuracy of energy distribution predictions by 0.6%. Tenth Place: Ray Zhang, 17, of Chantilly, VA received a $40,000 award for studying how to better treat drug-resistant Fusarium fungal infections. Ray studied how the fungus builds sticky communities of cells that resist drug treatment. He also found that using a combination of drugs better controlled the fungus. Akilan Sankaran, 17, of Albuquerque, NM was named the Seaborg Award winner and selected to speak on behalf of the Regeneron Science Talent Search Class of 2025. The 40 finalists chose Akilan as the student who best exemplifies their class and the legacy of nuclear chemist Glenn T. Seaborg, who won the Nobel Prize for Chemistry in 1951 and served on the Society’s Board of Trustees for 30 years. All other finalists received $25,000. All 40 finalists join a distinguished group of Science Talent Search alumni, many of whom have gone on to achieve world-changing careers in STEM, with some earning esteemed honors, including the Nobel Prize, National Medal of Science, and MacArthur Fellowship. In total, Regeneron awarded $3.1 million in prizes, including $2,000 to each top scholar and their school. Learn more about Regeneron Science Talent Search at https://www.societyforscience.org/regeneron-sts/ and learn about all their research projects at our Virtual Public Showcase. For media resources, visit https://www.societyforscience.org/2025-regeneron-science-talent-search-media-kit About Society for Science Society for Science is a champion for science, dedicated to promoting the understanding and appreciation of science and the vital role it plays in human advancement. Established in 1921, Society for Science is best known for its award-winning journalism through Science News and Science News Explores, its world-class science research competitions for students, including the Regeneron Science Talent Search, the Regeneron International Science and Engineering Fair and the Thermo Fisher Scientific Junior Innovators Challenge, and its outreach and equity programming that seeks to ensure that all students have an opportunity to pursue a career in STEM. A 501(c)(3) membership organization, Society for Science is committed to inform, educate and inspire. Learn more at www.societyforscience.org and follow us on Facebook, Twitter, Instagram and Snapchat (Society4Science). About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, hematologic conditions, infectious diseases and rare diseases. Regeneron believes that operating as a good corporate citizen is crucial to delivering on our mission. We approach corporate responsibility with three goals in mind: to improve the lives of people with serious disease, to foster a culture of integrity and excellence and to build sustainable communities. Regeneron is proud to be included on the Dow Jones Sustainability World Index and the Civic 50 list of the most “community-minded” companies in the U.S. Throughout the year, Regeneron empowers and supports employees to give back through our volunteering, pro-bono and matching gift programs. Our most significant philanthropic commitments are in the area of science education, including the Regeneron Science Talent Search and the Regeneron International Science and Engineering Fair (ISEF). For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook or X. Media Contacts Joseph Brown, Regeneron 386-283-1323, joseph.brown2@regeneron.com Gayle Kansagor, Society for Science 703-489-1131, gkansagor@societyforscience.org Source: Regeneron Pharmaceuticals, Inc.

31 Mar 2023

·www.biopharmadive.com

Cytokinetics to end late-stage study of ALS drug

The California-based biotechnology company Cytokinetics on Friday announced plans to discontinue a late-stage clinical trial evaluating one of its experimental drugs as a treatment for ALS.Cytokinetics said its decision follows the recommendation of an outside group of advisers who got an early look at some of the trial data. This group was tasked with conducting an interim futility analysis to determine whether the drug, called reldesemtiv, was unlikely to meet the studys goals. According to Cytokinetics, the advisers concluded the drug had no evidence of effect across the studys main and key secondary objectives.We are extremely disappointed with this outcome and would like to thank the people with ALS, caregivers, investigators and clinical trial staff for their participation, Cytokinetics CEO Robert Blum said in a statement, adding that the company will assess next steps relating to our neuromuscular development programs in the coming months.ALS, or amyotrophic lateral sclerosis, is an often rapid, always fatal disease characterized by the progressive erosion of nerve cells. To date, the Food and Drug Administration has approved three medicines specifically for ALS. But each has limited effects on function and survival, and, even with treatment, patients still live an average of just two to five years once symptoms arise.Cytokinetics ALS research has revolved around troponin, a protein involved in muscle movement, with the idea being that activating this protein may help treat the disease. The companys first attempt at this resulted in an experimental medicine called tirasemtiv, but it was shelved after missing the primary goal of a late-stage study that enrolled around 750 ALS patients.Reldesemtiv is newer, and designed a bit differently than its predecessor. Yet Cytokinetics has still had trouble proving the drugs merits in ALS. It failed a mid-stage study in 2019. And, according to Mizuho Securities analyst Salim Syed, Wall Street has ascribed nearly no value to the drug.Instead, investors have been focused on aficamten, a drug Cytokinetics is developing for hypertrophic cardiomyopathy, and, until recently, another medication for heart failure that the FDA rejected last month in a closely watched decision.For its latest ALS treatment, Cytokinetics set up its Phase 3 trial to have two interim futility analyses, with the first one taking place last year. At the time, the unblinded data available to the external advisers were from three months after at least one-third of the intended number of participants which is set at 555 had been enrolled and randomized.The advisers ultimately concluded the trial should continue, which was not a surprise, according to Syed, as Cytokinetics chief medical officer had previously told investors the bar for moving forward was fairly low.The second interim analysis, meanwhile, was scheduled to occur six months after at least one-third of the intended number of participants were randomized. Cytokinetics said this evaluation was conducted after approximately 460 patients had been assigned to an arm in the study and more than 200 had been assessed for 24 weeks.The trials main objective was to look for how scores on a widely used scale for measuring ALS symptoms changed over a 24-week treatment period. '

Phase 3

04 Aug 2022

·www.biospace.com

Cytokinetics and The ALS Association Announce Release of Updated PRO-ACT Database Including Data From Cytokinetics’ Completed ALS Clinical Trials

SOUTH SAN FRANCISCO, Calif., AND WASHINGTON, Aug. 04, 2022 (GLOBE NEWSWIRE) -- Cytokinetics, Inc. (Nasdaq: CYTK) and The ALS Association today announced a new release of the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) database updated with clinical data from Cytokinetics’ completed clinical trials in ALS including, BENEFIT-ALS (Blinded Evaluation of Neuromuscular Effects and Functional Improvement with Tirasemtiv in ALS), VITALITY-ALS (Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices after Treatment for a Year in ALS) and FORTITUDE-ALS (Functional Outcomes in a Randomized Trial of Investigational Treatment with CK-2127107 to Understand Decline in Endpoints – in ALS). “We are pleased to share these data with the ALS community to further research, understanding and potential breakthroughs for people living with this grievous disease,” said Fady I. Malik, M.D., Ph.D., Cytokinetics’ Executive Vice President of Research & Development. “We recognize that we all benefit from shared insights, successes and even failures if we are going to ultimately make a difference in the lives of many. We thank the people living with ALS who participated in our clinical trials to make this possible.” “We are grateful to Cytokinetics for their partnership and transparency, enabling the global research community to leverage these data in their ongoing analyses and research activities,” said Neil Thakur, Ph.D., Chief Mission Officer at The ALS Association. The PRO-ACT database, which is sponsored by the ALS Association and managed by The Neurological Clinical Research Institute (NCRI) at Massachusetts General Hospital, houses the largest ALS clinical trials dataset, containing nearly 11,000 ALS de-identified patient records from 23 completed clinical trials. The platform harmonizes and merges anonymized data from existing publicly and privately conducted ALS clinical trials to generate a unique, freely available resource for the scientific community to help with finding cures for ALS. The PRO-ACT platform was selected as the Bio-IT World’s Best Practices Awards winner in 2013 and The Clinical Informatics News Best Practices winner in Clinical Data Intelligence category in 2015. The PRO-ACT platform was created by Prize4Life Israel, a non-profit organization, in partnership with the Northeast ALS Consortium (NEALS) and the NCRI, and with initial funding from The ALS Therapy Alliance, Prize4Life, NCRI, and The ALS Association. To date, PRO-ACT has served as the primary data source for more than 80 publications and has been critical for numerous others. The platform has allowed researchers to better understand disease heterogeneity, develop novel predictive models of disease progression and has been a critical tool to support the design of several ALS clinical trials. About ALS Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease that afflicts approximately 27,000 people in the United States and a comparable number of patients in Europe. Approximately 6,300 new cases of ALS are diagnosed each year in the United States. The average life expectancy of a person with ALS is approximately three to five years after diagnosis and only approximately 10 percent of people with ALS survive for more than 10 years. Death is usually due to respiratory failure because of diminished strength in the skeletal muscles responsible for breathing. Few treatment options exist for these patients, resulting in a high unmet need for new therapies to address functional deficits and disease progression. About Cytokinetics Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact muscle function and contractility. Cytokinetics is readying for the potential commercialization of omecamtiv mecarbil, its cardiac muscle activator, following positive results from GALACTIC-HF, a large, international Phase 3 clinical trial in patients with heart failure. Cytokinetics is also developing aficamten, a next-generation cardiac myosin inhibitor, currently the subject of SEQUOIA-HCM, the Phase 3 clinical trial of aficamten in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM). Aficamten is also being evaluated in non-obstructive HCM in Cohort 4 of the Phase 2 clinical trial, REDWOOD-HCM. Cytokinetics is also developing reldesemtiv, an investigational fast skeletal muscle troponin activator, currently the subject of COURAGE-ALS, a Phase 3 clinical trial in patients with amyotrophic lateral sclerosis (ALS). Cytokinetics continues its over 20-year history of pioneering innovation in muscle biology and related pharmacology focused to diseases of muscle dysfunction and conditions of muscle weakness. For additional information about Cytokinetics, visit and follow us on Twitter, LinkedIn, Facebook and YouTube. About The ALS Association The ALS Association is the largest philanthropic funder of ALS research in the world. The Association funds global research collaborations, assists people with ALS and their families through its nationwide network of care, and advocates for better public policies for people with ALS. The ALS Association is working to make ALS a livable disease while urgently searching for new treatments and a cure. For more information about The ALS Association, visit our website at 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 any of our other clinical trials, statements relating to the potential benefits of reldesemtiv, omecamtiv mecarbil, aficamten, or any of our other drug candidates; Cytokinetics' research and development activities; the design, timing, results, significance and utility of preclinical and clinical results; and the properties and potential benefits of 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; Cytokinetics' drug candidates may have adverse side effects or inadequate therapeutic efficacy; the FDA or foreign regulatory agencies may delay or limit Cytokinetics' ability to conduct clinical trials; Cytokinetics may be unable to obtain or maintain patent or trade secret protection for its intellectual property; standards of care may change, rendering Cytokinetics' drug candidates obsolete; and competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics' drug candidates and potential drug candidates may target. For further information regarding these and other risks related to Cytokinetics' business, investors should consult Cytokinetics' filings with the Securities and Exchange Commission. CYTOKINETICS® and the CYTOKINETICS and C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries. Contact: Cytokinetics Diane Weiser Senior Vice President, Corporate Communications, Investor Relations (650) 624-3071

First in ClassSmall molecular drugCollaborate

100 Deals associated with Tirasemtiv

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Amyotrophic Lateral Sclerosis	Phase 3	United States	Cytokinetics, Inc.	03 Sep 2015
Amyotrophic Lateral Sclerosis	Phase 3	Belgium	Cytokinetics, Inc.	03 Sep 2015
Amyotrophic Lateral Sclerosis	Phase 3	Canada	Cytokinetics, Inc.	03 Sep 2015
Amyotrophic Lateral Sclerosis	Phase 3	France	Cytokinetics, Inc.	03 Sep 2015
Amyotrophic Lateral Sclerosis	Phase 3	Germany	Cytokinetics, Inc.	03 Sep 2015
Amyotrophic Lateral Sclerosis	Phase 3	Ireland	Cytokinetics, Inc.	03 Sep 2015
Amyotrophic Lateral Sclerosis	Phase 3	Italy	Cytokinetics, Inc.	03 Sep 2015
Amyotrophic Lateral Sclerosis	Phase 3	Netherlands	Cytokinetics, Inc.	03 Sep 2015
Amyotrophic Lateral Sclerosis	Phase 3	Portugal	Cytokinetics, Inc.	03 Sep 2015
Amyotrophic Lateral Sclerosis	Phase 3	Spain	Cytokinetics, Inc.	03 Sep 2015

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02936635 (VIGOR-ALS, CTgov)	Phase 3	Amyotrophic Lateral Sclerosis	280	tirasemtiv (Delayed Start Treatment)	vurcftxjnq = zgroqazvco tythlopkoj (hsnxaalfoy, ixbaflzdil - bqtwlbvrpc) View more	-	12 May 2021
				tirasemtiv (Early Start Treatment)	vurcftxjnq = oxfamdmgby tythlopkoj (hsnxaalfoy, yqrogmwtrn - vvdnsuotun) View more
NCT02496767 (VITALITY-ALS, CTgov)	Phase 3	Amyotrophic Lateral Sclerosis	744	placebo (Double-blind, Placebo-controlled: Group 1 - Placebo)	uwppugycgo(pfdptwrdzv) = miibeehzal qihqxgnhqj (imwbgjipbh, 1.2270) View more	-	19 Jun 2020
				Tirasemtiv (Double-blind, Placebo-controlled: Group 2 - 250 mg Tirasemtiv)	uwppugycgo(pfdptwrdzv) = aewqofcoar qihqxgnhqj (imwbgjipbh, 1.5165) View more
NCT01709149 (CTgov)	Phase 2	Amyotrophic Lateral Sclerosis	711	Placebo tablets+Riluzole	sukfnrbdgm(pkmviazioy) = lyitlcfuwt kwngztkplp (tujxgghmaq, 0.246) View more	-	31 Mar 2020
NCT02496767 (VITALITY-ALS, Pubmed \| Amyotroph Lateral Scler Frontotemporal Degener) Manual	Phase 3	Amyotrophic Lateral Sclerosis	565	tirasemtiv	bstqjjinfo(vllyvfjcbx) = vvtsniwgip ixjavhhtcw (pneeangiju, -15.3 to -11.6)	Negative	01 Jan 2019
				Placebo	bstqjjinfo(vllyvfjcbx) = kmusxmsfga ixjavhhtcw (pneeangiju, -16.8 to -11.9)
NCT01709149 (Pubmed \| Amyotroph Lateral Scler Frontotemporal Degener) Manual	Phase 2	Amyotrophic Lateral Sclerosis	711	tirasemtiv	gjgwxakmtf(dkoyvwctzb) = vcemfjzzcv fgjfyuuwxl (wppvjtajwb, 0.28)	Negative	01 Jul 2016
				Placebo	gjgwxakmtf(dkoyvwctzb) = avdnwdzqpz fgjfyuuwxl (wppvjtajwb, 0.25)
NCT01268280 (Pubmed)	Phase 2	Myasthenia Gravis	32	Tirasemtiv 250 mg	dzfkbcolag(wtqjdlkfdl) = kqkkzcodip gcntacuekc (gvabsuhozv )	Positive	01 Apr 2015

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