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Omecamtiv Mecarbil Matrix F1 Formulation

Phase 2

Modified Release Oral Formulation | Small molecule | Cardiovascular |Cytokinetics, Incorporated|Last Updated: Aug 12, 2021

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment544
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01786512COSMIC-HF - Chronic Oral Study of Myosin Activation to Increase Contractility in Heart FailurePHASE2 COMPLETED 544 — — Feb 26, 2013Aug 19, 2015Aug 12, 2021101 United States, Australia +11
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Study Endpoints
Primary Endpoints
Dose Escalation Phase: Maximum Observed Plasma Concentration (Cmax) of Omecamtiv Mecarbil Following the Last Dose (Day 7)
Day 7 at predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours, and 7 days post-dose.
Dose Escalation Phase: Time to Maximum Observed Plasma Concentration (Tmax) of Omecamtiv Mecarbil Following the Last Dose (Day 7)
Day 7 at predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours, and 7 days post-dose.
Dose Escalation Phase: Plasma Concentration of Omecamtiv Mecarbil Prior to Dosing on Day 7
Day 7 at predose
Dose Escalation Phase: Area Under the Plasma Concentration-time Curve for a Dosing Interval of 12 Hours Post Dose (AUC12) for Omecamtiv Mecarbil
Day 7 at predose and at 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post-dose
Expansion Phase: Plasma Concentration of Omecamtiv Mecarbil Prior to Dosing
Predose (before morning dose) at weeks 2, 8, 12, 16, and 20
Expansion Phase: Maximum Observed Plasma Concentration of Omecamtiv Mecarbil
Weeks 2 and 12 at predose and 1, 2, 4, 6, and 8 hours post-dose.
Secondary Endpoints
Expansion Phase: Change From Baseline in Systolic Ejection Time (SET) at Week 20
Baseline and week 20
Expansion Phase: Change From Baseline in Stroke Volume at Week 20
Baseline and week 20
Expansion Phase: Change From Baseline in Left Ventricular End Systolic Diameter (LVESD) at Week 20
Baseline and week 20
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose-escalation Cohort 1: PlaceboPLACEBO_COMPARATORParticipants received placebo tablets twice a day (BID) for 7 days.
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F1EXPERIMENTALParticipants received 25 mg omecamtiv mecarbil (OM) Matrix F1 (M-F1) tablets twice a day for 7 days.
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F2EXPERIMENTALParticipants received 25 mg omecamtiv mecarbil Matrix F2 (M-F2) tablets twice a day for 7 days.
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg SCT-F2EXPERIMENTALParticipants received 25 mg omecamtiv mecarbil swellable core technology F2 (SCT-F2) tablets twice a day for 7 days.
Dose-escalation Cohort 2: PlaceboPLACEBO_COMPARATORParticipants received placebo tablets twice a day for 7 days.
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F1EXPERIMENTALParticipants received 50 mg omecamtiv mecarbil M-F1 tablets twice a day for 7 days.
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F2EXPERIMENTALParticipants received 50 mg omecamtiv mecarbil M-F2 tablets twice a day for 7 days.
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg SCT-F2EXPERIMENTALParticipants received 50 mg omecamtiv mecarbil SCT-F2 tablets twice a day for 7 days.
Expansion Phase: PlaceboPLACEBO_COMPARATORParticipants received placebo tablets twice a day for 20 weeks.
Expansion Phase: Omecamtiv Mecarbil 25 mg M-F1EXPERIMENTALParticipants received 25 mg omecamtiv mecarbil M-F1 tablets twice a day for 20 weeks.
Expansion Phase: OM M-F1 PK-based TitrationEXPERIMENTALAll participants received 25 mg omecamtiv mecarbil M-F1 tablets twice a day. At week 8 the dose escalated to 50 mg twice a day if the week 2 predose plasma concentration of OM was less than the predefined cutoff of 200 ng/mL.
Interventions
NameTypeDescription
Omecamtiv Mecarbil Matrix F1 FormulationDRUGModified release tablets for oral administration
Omecamtiv Mecarbil Matrix F2 FormulationDRUGModified release tablets for oral administration
PlaceboDRUGModified release tablets matching to omecamtiv mecarbil
Omecamtiv Mecarbil Swellable Core Technology F2DRUGModified release tablets for oral administration
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Eligibility Criteria
Age Range18 Years — 85 Years
SexALL
Healthy VolunteersNo
Study Sites101

Inclusion Criteria: * History of chronic heart failure (HF), defined as requiring treatment for HF for a minimum of 4 weeks prior to screening * Treated with stable, optimal pharmacological therapy for ≥ 4 weeks * History of left ventricular ejection fraction (LVEF) ≤ 40% * Elevated N-terminal proh...

Countries:United StatesAustraliaBelgiumBulgariaCanadaCzechiaGermanyHungaryItalyLithuaniaNetherlandsPolandUnited Kingdom
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