US-based LifeMine Therapeutics has dosed the first subject in the Phase I trial of calcineurin inhibitor (CNi), LIFE-001, intended as a “prelude” to immune-mediated disorders and organ transplant rejection treatment.
This first-in-human trial aims to assess the therapy for its effectiveness, tolerability, drug exposure and safety of T cell suppression in the blood.
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LIFE-001’s pharmacokinetics, tolerability, pharmacodynamics and safety profile will be assessed in the trial, with the Phase Ia multiple/single-ascending dose portion set to enrol around 100 adults.
The subsequent Phase Ib portion of the trial will focus on the preliminary efficacy of the therapy across several cohorts of immune-mediated disease, inclusive of ulcerative colitis.
LifeMine has obtained the necessary funds for the whole Phase Ia trial and is actively raising further capital to support efficacy trials and offer investment catalysts in the coming years.
LifeMine Therapeutics CEO, co-founder and president Gregory Verdine said: “LifeMine’s transition into a clinical-stage company marks a significant achievement for our team and underscores the power of our genomic discovery engine to bring sophisticated medicines to patients in urgent need of breakthrough disease intervention.”
The company says that the therapy is an organ-sparing, controlled-release and precision-engineered immunophilin-independent CNi tailored de novo to prevent the immunophilin-dependent organ damage typically seen with legacy CNis.
LifeMine’s chief medical officer Simon Cooper said: “CNis have been a primary treatment for organ and tissue transplantation, as well as multiple immune-mediated disorders, for many years.
“We have designed LIFE-001 to replace all legacy CNis with a potential best-in-class new drug having improved safety and tolerability, predictability of drug exposure with a long-acting injectable formulation, and greatly improved convenience and freedom from burdensome blood monitoring and concomitant therapy to counter side-effects.”
