CIVI 007 / CiVi Biopharma - LARVOL DELTA

Phase 2a Study to Assess CIVI 007 in Patients on a Background of Statin Therapy (clinicaltrials.gov) - P2 | N=49 | Completed | Sponsor: Civi Biopharma, Inc. | Phase classification: P2a ➔ P2

Phase classification • Dyslipidemia • Metabolic Disorders

The translational potential of miR-26 in atherosclerosis and development of agents for its target genes ACC1/2, COL1A1, CPT1A, FBP1, DGAT2, and SMAD7. (PubMed, Cardiovasc Diabetol) - "Many agents targeting these genes, such as the ACC1/2 inhibitors GS-0976, PF-05221304, and MK-4074; the DGAT2 inhibitors IONIS-DGAT2Rx, PF-06427878, PF-0685571, and PF-07202954; the COL1A1 inhibitor HT-100; the stimulants Ga-CBP8 and RCT-01; the CPT1A inhibitors etomoxir, perhexiline, and teglicar; the FBP1 inhibitors CS-917 and MB07803; and the SMAD7 inhibitor mongersen, have been investigated in clinical trials...Many PCSK9 inhibitors, including alirocumab, evolocumab, inclisiran, AZD8233, Civi-007, MK-0616, and LIB003, have been investigated in clinical trials...Multiple materials can be used to deliver miR-26, but it is unclear which material is most suitable for mass production and clinical applications. This review focuses on the potential use of miR-26 in treating atherosclerosis to support the development of agents targeting it."

Journal • Review • Atherosclerosis • Cardiovascular • Dyslipidemia • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • ABCA1 • ACACA • ACSL3 • BMP2 • CD36 • COL1A1 • CPT1A • CTGF • EHHADH • HMGB1 • IFNA1 • IL1B • IL6 • MALT1 • RUNX2 • SCARB1 • SMAD7 • TCF7L2 • TNFA

Phase 2a Study to Assess CIVI 007 in Patients on a Background of Statin Therapy (clinicaltrials.gov) - P2a; N=49; Completed; Sponsor: Civi Biopharma, Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Dyslipidemia • Metabolic Disorders

A First In Human Study to Assess CiVi007 in Subjects With an Elevated LDL-Cholesterol Level (clinicaltrials.gov) - P1; N=36; Completed; Sponsor: Civi Biopharma, Inc.; Active, not recruiting ➔ Completed; N=68 ➔ 36; Trial primary completion date: Jul 2020 ➔ Feb 2020

Clinical • Enrollment change • Trial completion • Trial primary completion date • Dyslipidemia • Metabolic Disorders

A First In Human Study to Assess CiVi007 in Subjects With an Elevated LDL-Cholesterol Level (clinicaltrials.gov) - P1; N=68; Active, not recruiting; Sponsor: Civi Biopharma, Inc.; Trial completion date: Apr 2020 ➔ Sep 2020; Trial primary completion date: Jan 2020 ➔ Jul 2020

Clinical • Trial completion date • Trial primary completion date • Dyslipidemia • Metabolic Disorders

Phase 2a Study to Assess CIVI 007 in Patients on a Background of Statin Therapy (clinicaltrials.gov) - P2a; N=48; Active, not recruiting; Sponsor: Civi Biopharma, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed