GL-2045 in Patients
GL-2045 is currently in clinical trial in patients with Immune Thrombocytopenia (“ITP”). GL-2045 is designed as a recombinant version of the active fraction of the blood product IVIg. ITP is the first of many clinical autoimmune indications in which GL-2045 will be studied as replicating IVIg known efficacy. GL-2045 is expected to be active in every autoimmune disease in which IVIg has proven efficacy, including six regulatory approved indications and numerous others.
GL-2045 is anticipated to have many potential advantages over IVIg in the chronic treatment of ITP and other autoimmune conditions such as CIDP. Included among these is convenient under-the-skin (“SC”) injection as a result of greater potency and far lower volume. Lower doses are expected to be associated with an improved safety and tolerability profile. Other expected improvements include unlimited supply and enhanced product consistency, stability, and purity.
GL-2045 has been generally safe and well tolerated with no drug-related Serious Adverse Events in about 45 study participants who have received GL-2045 SC.
GL-0719 in Patients
GL-0719 is designed to have the complement modulation of IVIg but at far lower doses than needed with IVIg to inhibit the classical and lectin complement pathways. GL-0719 is currently in clinical trial in patients with Cold Agglutinin Disease. GL-0719 is designed for treating autoimmune diseases caused by over-activation of the classical and lectin pathways.
GL-0719 is anticipated to have advantages over other upstream complement modulators in the treatment of complement-mediated autoimmune conditions. Similar to GL-2045, convenient SC injection is feasible because of low doses needed. Complement modulation by GL-0719’s unique mechanism is expected to be associated with an improved safety and tolerability profile relative to competitive approaches.
GL-0719 has been generally safe and well tolerated with no drug-related Serious Adverse Events in nearly 50 study participants who have received GL-0719 IV or SC.
Our Approach
At Gliknik, our expertise is in modulation of the immune system and our mission is to discover and develop innovative biologics for people living with immune disorders.
Our determination to make a difference in the lives of individuals with autoimmune disease is evidenced by the assembly of talented scientists, augmented by our Board members, scientific advisors and a network of worldwide scientific and medical thought leaders.