NPC-21 / Nobelpharma, Evec - LARVOL DELTA

Phase 2, Randomized, Double-blind, Placebo-controlled Study of Fiztasovimab (NPC-21) for Kidney Transplant Recipients at High Risk of Cytomegalovirus Infection (LionHeart21). (PubMed, Transplantation) - "NPC-21 was safe, but no significant efficacy difference was found between NPC-21 and placebo. Severe CMV infection was less likely in the NPC-21 group versus the placebo group. Further studies are needed to elucidate the role of NPC-21 in the prevention of CMV."

Clinical • Journal • P2 data • Chronic Kidney Disease • Cytomegalovirus Infection • Infectious Disease • Nephrology • Renal Disease • Transplantation

NPC-21: A Potential Game Changer in the Fight Against Cytomegalovirus Disease in Transplant Recipients. (PubMed, Transplantation) - No abstract available

Journal • Cytomegalovirus Infection • Infectious Disease • Transplantation

Population Pharmacokinetics and Exposure-Response Analysis of Fiztasovimab, Anti-Cytomegalovirus Monoclonal Antibody, in a Phase 2 Randomized Controlled Trial to Prevent Cytomegalovirus Infection in Kidney Transplant Recipients (ATC 2024) - "*Purpose: The proper concentration of fiztasovimab, NPC-21, to prevent cytomegalovirus (CMV) infection in kidney transplant recipients has yet to be discovered.* A randomized, double-blinded, placebo-controlled trial was conducted to assess the efficacy and safety of fiztasovimab as CMV prophylaxis in CMV D+/R- kidney transplant recipients... The final Pop-PK model described the fiztasovimab concentration profile for each patient. A higher Cave is likely to prevent at least severe CMV disease in kidney transplant recipients."

Clinical • P2 data • PK/PD data • Cytomegalovirus Infection • Infectious Disease • Nephrology • Renal Disease • Transplantation

A Phase 2, Randomized Controlled Trial of Anti-CMV Monoclonal Antibody, Fiztasovimab, to Prevent CMV Infection in Kidney Transplant Recipients: The LionHeart21 Study (ATC 2023) - P2 | "Purpose: To assess the efficacy and safety of fiztasovimab (NPC-21) a fully human immunoglobulin 1λ monoclonal antibody that targets the antigenic domain 1 on the human cytomegalovirus (CMV) glycoprotein B, as prophylaxis in kidney transplant recipients at high risk of CMV infection (D+/R-)... Data will be analyzed after all participants have been followed up. The key efficacy and safety results will be presented at ATC 2023."

Clinical • Late-breaking abstract • P2 data • Cytomegalovirus Infection • Infectious Disease • Transplantation

A Study for Kidney Transplant Recipients at High-Risk of Cytomegalovirus Infection (clinicaltrials.gov) - P2 | N=87 | Completed | Sponsor: Nobelpharma | Active, not recruiting ➔ Completed

Trial completion • Cytomegalovirus Infection • Infectious Disease • Transplantation

A Study for Kidney Transplant Recipients at High-Risk of Cytomegalovirus Infection (clinicaltrials.gov) - P2 | N=108 | Active, not recruiting | Sponsor: Nobelpharma | Recruiting ➔ Active, not recruiting

Enrollment closed • Cytomegalovirus Infection • Infectious Disease • Transplantation

Pharmacokinetics, Safety, and Tolerability of NPC-21, an Anti-Cytomegalovirus Monoclonal Antibody, in Healthy Japanese and White Adult Men: A Randomized, Placebo-Controlled, First-in-Human Phase 1 Study. (PubMed, Clin Pharmacol Drug Dev) - "There were no differences in pharmacokinetics or safety between Japanese and White participants. These results support further investigation of NPC-21."

Clinical • Journal • P1 data • PK/PD data • Bone Marrow Transplantation • Cytomegalovirus Infection • Solid Organ Transplantation • Transplantation

A Study for Kidney Transplant Recipients at High-Risk of Cytomegalovirus Infection (clinicaltrials.gov) - P2; N=108; Recruiting; Sponsor: Nobelpharma; Trial completion date: Mar 2022 ➔ Feb 2023; Trial primary completion date: Jan 2022 ➔ Nov 2022

Clinical • Trial completion date • Trial primary completion date • Cytomegalovirus Infection • Infectious Disease • Transplantation

"Thank you to #NPC21 Silver-level sponsor, @AbbottNews!" (@NASSP)

A Study for Kidney Transplant Recipients at High-Risk of Cytomegalovirus Infection (clinicaltrials.gov) - P2; N=108; Recruiting; Sponsor: Nobelpharma; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Cytomegalovirus Infection • Infectious Disease

Phase 2 Study for Kidney Transplant Recipients at High-Risk of Cytomegalovirus Infection (clinicaltrials.gov) - P2; N=108; Not yet recruiting; Sponsor: Nobelpharma

Clinical • New P2 trial