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CytoKinetics – On the Threshold of some big Catalysts!

15 Apr CytoKinetics – On the Threshold of some big Catalysts!

CytoKinetics, Inc. (NASDAQ: CYTK), a late-stage biopharmaceutical company, is developing therapeutics for the treatment of cardiovascular and neuromuscular diseases that are characterized by impaired muscle function such as amyotrophic lateral sclerosis (ALS), spinal muscular atrophy (SMA) heart failure and hypertrophic cardiomyopathies (HCM).

The Company announced preclinical data for CK-3773274 (CK-274), a potential Next-In-Class Cardiac Myosin Inhibitor, intended for the treatment of hypertrophic cardiomyopathy (HCM) at the American Chemical Society Spring 2021 Virtual Meeting, along with the first disclosure of its chemical structure. CytoKinetics also reviewed the evaluation of CK-274 and precursor compounds for exposure-response relationship, projected human half-life, and potential for meaningful cytochrome P450 (CYP450) interactions.

CK-274, is a small molecule cardiac myosin inhibitor that has the potential to reduce hypercontractility in hypertrophic cardiomyopathy (HCM). The candidate has demonstrated the ability to reduce myocardial contractility, along with compensatory cardiac hypertrophy and cardiac fibrosis in preclinical studies.

Brad Morgan, Ph.D., Cytokinetics’ Senior Vice President, Research and Non-Clinical Development, stated,

“These preclinical data provide a first look at the structure of our next-in-class cardiac myosin inhibitor, CK-274, and its performance in certain preclinical assays. CK-274 was synthesized from a newly discovered and distinct chemical series following an optimization program that was intentionally focused on key compound physiochemical characteristics, such as a shallow dose-response relationship and a half-life that may enable flexible and timely dosing adjustments. We look forward to results from REDWOOD-HCM, the Phase 2 clinical trial of CK-274, which is designed to elaborate on how these differentiated properties may translate into its potential use in patients with obstructive HCM.”

The Company also carried out a comparison of CK-274 to mavacamten, which was developed from the initial discovery of Cytokinetics’ scientist’s efforts in collaboration with Myokardia, Inc. Which was acquired by Bristol-Myers Squibb (NYSE: BMY).

The data suggests that CK-274 may be a next-in-class, cardiac myosin inhibitor with a shallow pharmacokinetic/pharmacodynamic relationship and pharmacokinetics that may provide for flexible dose titration. The Company will now evaluate the safety, efficacy and tolerability of CK-274 in patients with obstructive HCM.

CytoKinetics, Inc. (NASDAQ: CYTK)

Market Cap: $1.74B; Current Share Price: 24.26 USDChart
Data by YCharts

Hypertrophic cardiomyopathies (HCM) cause abnormal thickness in the heart muscles, making it difficult for the heart to pump blood. The disease has very few symptoms, which makes it hard to diagnose. While most of the people with the condition can lead a normal life, in some cases it causes shortness of breath, chest pain and abnormal heart rhythms or arrhythmias.

The disease is caused by genetic mutations and can be categorised into obstructive hypertrophic cardiomyopathy or nonobstructive hypertrophic cardiomyopathy. Complications arising from this disease include Atrial fibrillation, mitral valve problems, cardiac arrest and dilated cardiomyopathy among others.

HCM can be diagnosed through echocardiogram, electrocardiogram or an MRI. The treatment options include medication such as Beta blockers, calcium channel blockers and blood thinners.  In more severe cases surgeries or other procedures such as Septal myectomy, Septal ablation or Implantable cardioverter-defibrillator (ICD) may be advised.

According to a report by Reports and Data, the global Hypertrophic Cardiomyopathy market is projected to reach USD 1.42 billion by the year 2027, growing at a CAGR of 2.1%, from  USD 1.20 billion in 2019

Amyotrophic Lateral Sclerosis (ALS) or Lou Gehrig’s disease is a progressive neurodegenerative disease, characterized by the atrophy of nerve cells in the brain and spinal cord, leading to hardening and scarring in the affected region. As the disease progresses, patients gradually lose the functioning of muscles, including those that control speech, movement and breathing. The disease manifests in two forms, sporadic and familial, with 90 to 95 percent of all cases in the U.S being Sporadic. Familial or the inherited form of the disease constitutes the other 5 to 10 percent.

Image Source: ALS.org

According to information made available by the ALS association, there are over 16,500 Americans afflicted by this illness and nearly 5000 new cases are diagnosed each year. The life expectancy after diagnosis is merely 2 to 5 years, with an estimated $250,000 being spent on out-of-pocket treatment costs. The Global ALS treatment market is expected to be worth over USD 3.6 billion by 2026, growing at a CAGR of 21.6 percent, from USD 0.75 billion in 2018, according to a report by Data Bridge Market Research.

has entered into strategic collaboration with Companies such as Amgen (NASDAQ: AMGN), RTW/XI JING, and Astellas (OTCPK: ALPMY) to develop and commercialize its diverse pipeline. The Company is developing omecamtiv mecarbil, a selective cardiac myosin activator, intended for the treatment of heart failure with reduced ejection fraction (HFrEF). The candidate has undergone seven phase 2 clinical trials, which evaluated its safety, efficacy and tolerability in patients with chronic heart failure and left ventricular systolic dysfunction.  The Company is currently engaged in two phase 3 clinical trial namely, GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) and METEORIC-HF, (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure).

Image Source: Company

The Company is also developing CK-274, which is currently being evaluated in a phase 3 clinical trial namely, REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM), in patients with symptomatic, obstructive HCM.

CytoKinetics is developing RELDEMESTIV in collaboration with Astellas. The investigational drug candidate is a fast skeletal muscle troponin activator (FSTA), which can regulate the rate of calcium release from the regulatory troponin complex of fast skeletal muscle fibres. The Company is also collaborating with Astellas for the development of an Additional Skeletal Muscle Activator.

Image Source: Company

The Company conducted a Phase 2, double-blind, randomized, dose-ranging, placebo-controlled, parallel group study of Reldesemtiv in patients with ALS named FORTITUDE-ALS (Functional Outcomes in a Randomized Trial of Investigational Treatment with CK-2127107 to Understand Decline in Endpoints – in ALS). The study had enrolled over 458 patients with ALS in the US, Canada, Europe and Australia and showed lower decline than patients on placebo; however, it failed to meet its primary endpoint of change from baseline in slow vital capacity (SVC) after 12 weeks of dosing.

Key Takeaways

  • The Company is planning to meet the FDA to discuss GALACTIC-HF in Q1 2021. The Company had reported results from the GALACTIC-HF in Q4,2020, which demonstrated positive effect on the primary composite endpoint of cardiovascular death or heart failure events in patients receiving standard of care plus omecamtiv mecarbil, with potentially larger treatment effects in patients with increasingly lower ejection fractions. The Company believes the discussion can give clarity as to a potential registration path and is excited about possible commercialization of omecamtiv mecarbil, and is hopeful of advancing the other candidates in the pipeline into pivotal clinical trials.
  • CytoKinetics received an approval for its IND application in China for conducting a phase 1 study of CK-274, which is being developed a licensing and collaboration agreement with Ji Xing Pharmaceuticals Limited. The Company is also working on developing next-generation skeletal muscle activators under a joint research agreement with Astellas, that extended through March 31, 2021.
  • In May 2021, the Company will regain worldwide rights to develop and commercialize omecamtiv mecarbil and CK-136. CytoKinetics also intends to develop its “go-to-market” strategy and lay the groundwork for a potential commercial launch in the first half of 2021.
  • For 2021, the Company believes its revenue will be in the range of $23 to $28 million. CytoKinetics has a cash balance of $501 million, which is sufficient to fund its trials and operations for the next two years as per its estimates.
  • Clinical Trials are fraught with risk and uncertainty. However, CytoKinetics has a diverse pipeline of candidates which will help mitigate the risk in case of adverse results or the failure to meet endpoints in any of its ongoing trials. The success of its clinical trials will help the Company advance its pipeline but it should also be prepared to face any setbacks, in case its ongoing trial fails to meet their endpoints.
  • Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

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