CVI-LM001 / CVI Pharma - LARVOL DELTA

Lipid-Lowering Efficacy and Safety of Oral Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors: A Systematic Review and Meta-Analysis. (PubMed, Adv Ther) - "Oral PCSK9 inhibitors demonstrate lipid-lowering efficacy and safety comparable to that of currently approved injectable PCSK9 therapies. These findings support their potential as a convenient and effective alternative, although current evidence remains limited to early-phase studies."

Clinical • Journal • Retrospective data • Dyslipidemia • APOB

Emerging oral therapeutic strategies for inhibiting PCSK9. (PubMed, Atheroscler Plus) - "Subcutaneous administration of monoclonal antibodies (evolocumab and alirocumab) every 2 or 4 weeks determined a 60 % reduction of LDL cholesterol levels, while the GalNac-siRNA anti PCSK9 (inclisiran) provided an effective lipid lowering activity (-50 %) after an initial subcutaneous dose, repeated after 3 months and followed by a maintenance dose every 6 months. These problems could be overcome by the development of small chemical molecules anti PCSK9 as oral therapy for controlling hypercholesterolemia. In the present review, we summarized the pharmacological properties of oral anti PCSK9 molecules that are currently under clinical development (DC371739, CVI-LM001, and AZD0780), including the mimetic peptides enlicitide decanoate (MK-0616) and NNC0385-0434."

Journal • Review • Cardiovascular • Dyslipidemia • Metabolic Disorders

[VIRTUAL] CVI-LM001, a First-in-class Novel Oral PCSK9 Modulator, Lowers Plasma Ldl-c and Reduces Circulating PCSK9 in Preclinical Animal Models and in Hyperlipidemic Human Subjects (AHA 2020) - "Mean half-lives ranged from 32 to 45h after single dosing and 62 to 68h following multiple dosing. These studies, for the first time, demonstrate that CVI-LM001, a novel PCSK9 modulator, has the potential to be a new oral cholesterol-lowering drug and warrant further development."

Atherosclerosis • Cardiovascular • Dyslipidemia • Metabolic Disorders

"CVI-LM001 PCSK9 modulator at CVI Pharmaceuticals reduces LDL-levels in humans. #AHA20" (@Cortellis)

[VIRTUAL] CVI-LM001, A FIRST-IN-CLASS NOVEL ORAL PCSK9 MODULATOR FOR HYPERCHOLESTEROLEMIA AND NASH: PRECLINICAL AND FIRST-IN-HUMAN STUDIES (AASLD 2020) - "These studies demonstrate that CVI-LM001, a novel PCSK9 modulator, has the potential to be a new oral cholesterol-lowering drug to treat hypercholesterolemia and NAFLD/NASH."

P1 data • Preclinical • Cardiovascular • Dyslipidemia • Fibrosis • Hepatology • Immunology • Inflammation • Metabolic Disorders • Non-alcoholic Fatty Liver Disease • Non-alcoholic Steatohepatitis

Safety and Efficacy of CVI-LM001 in Patients With Hypercholesterolemia (clinicaltrials.gov) - P2; N=200; Recruiting; Sponsor: CVI Pharmaceuticals

Clinical • New P2 trial • Dyslipidemia • Metabolic Disorders