GL-2045 / Gliknik - LARVOL DELTA

A First in HumanTrial to Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-06755347 (clinicaltrials.gov) - P1 | N=58 | Terminated | Sponsor: Pfizer | Trial completion date: May 2024 ➔ Jan 2023 | Recruiting ➔ Terminated | Trial primary completion date: May 2024 ➔ Jan 2023; The Sponsor has decided to terminate the above referenced clinical study for business reasons. There were no safety concerns that led to this decision and there was no impact to participant safety.

Trial completion date • Trial primary completion date • Trial termination • Hematological Disorders • Pain • Thrombocytopenia • Thrombocytopenic Purpura

A First in HumanTrial to Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-06755347 (clinicaltrials.gov) - P1 | N=67 | Recruiting | Sponsor: Pfizer | Trial completion date: Nov 2023 ➔ May 2024 | Trial primary completion date: Nov 2023 ➔ May 2024

Trial completion date • Trial primary completion date • Hematological Disorders • Pain • Thrombocytopenia • Thrombocytopenic Purpura

A First in HumanTrial to Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-06755347 (clinicaltrials.gov) - P1 | N=67 | Recruiting | Sponsor: Pfizer | Trial completion date: Jun 2023 ➔ Nov 2023 | Trial primary completion date: Jun 2023 ➔ Nov 2023

Trial completion date • Trial primary completion date • Hematological Disorders • Pain • Thrombocytopenia • Thrombocytopenic Purpura

A First in HumanTrial to Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-06755347 (clinicaltrials.gov) - P1; N=67; Recruiting; Sponsor: Pfizer; Trial completion date: Oct 2022 ➔ Mar 2023; Trial primary completion date: Oct 2022 ➔ Mar 2023

Trial completion date • Trial primary completion date • Hematological Disorders • Pain • Thrombocytopenia • Thrombocytopenic Purpura

A First in HumanTrial to Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-06755347 (clinicaltrials.gov) - P1; N=67; Recruiting; Sponsor: Pfizer; N=112 ➔ 67; Trial completion date: Jun 2022 ➔ Oct 2022; Trial primary completion date: Jun 2022 ➔ Oct 2022

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Hematological Disorders • Pain • Thrombocytopenia • Thrombocytopenic Purpura

A First in HumanTrial to Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-06755347 (clinicaltrials.gov) - P1; N=112; Recruiting; Sponsor: Pfizer; N=84 ➔ 112

Enrollment change • Hematological Disorders • Pain • Thrombocytopenia • Thrombocytopenic Purpura

A First in HumanTrial to Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-06755347 (clinicaltrials.gov) - P1; N=84; Recruiting; Sponsor: Pfizer; Trial completion date: Dec 2021 ➔ Jun 2021; Trial primary completion date: Dec 2021 ➔ Jun 2021

Clinical • Trial completion date • Trial primary completion date • Hematological Disorders • Pain • Thrombocytopenia • Thrombocytopenic Purpura

A First in HumanTrial to Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-06755347 (clinicaltrials.gov) - P1; N=84; Recruiting; Sponsor: Pfizer; N=64 ➔ 84; Trial completion date: Oct 2020 ➔ Dec 2021; Trial primary completion date: Oct 2020 ➔ Dec 2021

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Hematological Disorders • Pain • Thrombocytopenia • Thrombocytopenic Purpura • F2

A fully recombinant human IgG1 Fc multimer (GL-2045) inhibits complement-mediated cytotoxicity and induces iC3b. (PubMed, Blood Adv) - "Our findings help elucidate how IVIG, GL-2045, and HAGG regulate complement function. Furthermore, the capacity of GL-2045 to sequester C1q and augment factor H activity, in combination with its ability to generate activation-induced immunomodulatory complement split products, such as iC3b, make it a viable drug candidate for the treatment of diverse complement-mediated diseases."

Journal • Biosimilar • Immunology • Inflammation

Next-generation Fc receptor-targeting biologics for autoimmune diseases. (PubMed, Autoimmun Rev) - "These include PF-06755347 (GL-2045), CSL730 (M230), CSL777 and Pan Fc Receptor Interacting Molecule (PRIM). Neonatal Fc receptor (FcRn)-targeting therapeutics block the FcRn receptor and are represented by candidate drugs such as the Fc fragment efgartigimod and the monoclonal antibodies rozanolixizumab (UCB7665), M281 and SYNT001. Finally, Fc and FcγR-targeting therapeutics, comprise molecules that target the Fc of IgG, such as the recombinant soluble FcγIIb receptor valziflocept (SM101/SHP652) and various monoclonal antibodies directed against the receptors...Although initial results are promising, further long-term data and a better understanding of the unique mechanisms of action of the different molecules are needed. The efficacy, safety, convenience of administration, duration of effects, and cost will all contribute to determining which of the molecules will be successful in the clinic."

Journal • Review

A recombinant human IgG1 Fc multimer designed to mimic the active fraction of IVIG in autoimmunity. (PubMed, JCI Insight) - "Furthermore, GL-2045 administration to nonhuman primates (NHPs) transiently increased systemic levels of the antiinflammatory cytokines IL-10 and IL-1RA, reduced the proinflammatory cytokine IL-8, and decreased surface expression of CD14 and HLA-DR on monocytes. These findings demonstrate the immunomodulatory properties of GL-2045 and suggest that it has potential as a treatment for autoimmune and inflammatory diseases, as a recombinant alternative to IVIG."

Journal