Recent Updates
Recently added Catalysts

ISIS 757456

Phase 2

Hypertension | Small molecule | Cardiovascular |Ionis Pharmaceuticals, Inc.|Last Updated: Jan 18, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment26
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04083222A Study to Assess the Safety, Tolerability and Efficacy of IONIS-AGT-LRxPHASE2 COMPLETED 26 — — Nov 13, 2019Jul 20, 2020Jan 18, 20239 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Percent Change From Baseline in Plasma Angiotensinogen (AGT) at Day 57 Compared to Placebo
Baseline up to Day 57 (start of Week 9)

The baseline for plasma AGT was defined as the average of all values prior to the first dose of study drug.

Secondary Endpoints
Change From Baseline in Systolic Blood Pressure (SBP) at Each Scheduled, Post-Baseline Visit
Baseline, Days 3, 8, 15, 22, 29, 36, 43, 50, 57, 64, 78, 92, 120, and 141
Absolute Change From Baseline in Plasma AGT at Each Scheduled, Post-Baseline Visit
Baseline, Days 3, 8, 15, 22, 29, 36, 43, 50, 57, 64, 78, 92, 120, and 141
Percent Change From Baseline in Plasma AGT at Each Scheduled, Post-Baseline Visit
Baseline, Days 3, 8, 15, 22, 29, 36, 43, 50, 64, 78, 92, 120, and 141
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATORParticipants received ISIS 757456-matching placebo, subcutaneous (SC) injection, once-weekly for 8 weeks and an additional loading dose on Day 3.
ISIS 757456EXPERIMENTALParticipants received ISIS 757456 80 mg, SC injection, once-weekly for 8 weeks and an additional loading dose on Day 3.
Interventions
NameTypeDescription
PlaceboDRUGISIS 757456-matching placebo solution administered as SC injection.
ISIS 757456DRUGISIS 757456 administered as SC injection.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion criteria: * Males or females aged 18-75 inclusive and weighing ≥ 50 kilograms (kg) at the time of informed consent * Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal * Males must be surgically sterile or, abstinent or, if engaged in sexual r...

Countries:United States
Unlock Eligibility Criteria
Competitive Landscape -Hypertension 42 trials
CompanyTickerTrialsLead PhaseDrugs
Eli Lilly and CompanyLLY4PHASE3Orforglipron, LY3971297
Alnylam Pharmaceuticals, IncALNY2PHASE3Zilebesiran, ALN-AGT01 RVR
Mineralys Therapeutics, Inc.MLYS1PHASE3lorundrostat
United Therapeutics CorporationUTHR1PHASE3Ralinepag
Novartis AG Sponsored ADRNVS3PHASE2QCZ484
Vanda Pharmaceuticals Inc.VNDA1PHASE2iloperidone
AstraZeneca PLCAZN3 — Undisclosed
Opus Genetics, Inc.IRD1PHASE1OPGx-BEST1
Novo Nordisk A/S Sponsored ADR Class BNVO1 — Undisclosed
Orchestra BioMed Holdings, Inc.OBIO3NAUndisclosed
CVRx, Inc.CVRX1NAMedical Management
Medtronic PlcMDT4NAUndisclosed
IQVIA Holdings IncIQV1NAUndisclosed
Verve Medical, IncVERV1NAActive hypertension medical therapy
Tango Therapeutics, Inc.TNGX1NATriple Fixed-Dose Combination, Usual Care Antihypertensive Regimen
Harvard Bioscience, Inc.HBIO1 — Undisclosed
Unlock Competitive Intelligence