LAPIX Therapeutics, Inc., a biopharmaceutical company dedicated to the development of innovative orally deliverable therapies for autoimmune diseases, has initiated the Phase 1 clinical trial for its LPX-TI641 therapy.

LPX-TI641 is an original, proprietary small molecule designed as an agonist for the T cell immunoglobulin and mucin domain-containing protein (Tim) 3/4 receptors. These Tim receptors play a pivotal role in autoimmunity. The primary objective of LPX-TI641 is to restore the balance of regulatory immune cells (T- and B-regs) in order to counter autoreactive T-cells and reestablish immune tolerance. The therapy is primarily intended for the treatment of Multiple Sclerosis (MS) but holds potential for addressing other autoimmune diseases such as rheumatoid arthritis and lupus.

Anas M. Fathallah, Ph.D., Chief Executive Officer and co-founder of LAPIX, expressed enthusiasm about the commencement of dosing for the first participants in the Phase 1 study. Dr. Fathallah highlighted the potential of LPX-TI641 as an immune tolerance restoration therapy that is not specific to any particular antigen. He believes it could significantly improve treatment options for patients with MS and various autoimmune diseases. The Phase 1 study's design allows for flexibility to explore its therapeutic potential for different autoimmune diseases, facilitating adaptation to other indications.

The Phase 1 study is a randomized, double-blind, placebo-controlled trial involving healthy adult volunteers. It aims to evaluate the safety, tolerability, and pharmacokinetics of LPX-TI641 following single ascending oral doses. Additionally, exploratory pharmacodynamic and biomarker analyses will be conducted as part of the study. More information about the study can be found at NCT05853835.

LPX-TI641 primarily functions by increasing the population of Foxp3+/CD4+ T-cells (T-regs) and Tim1+/CD25+/CD19+ (B-regs) while inhibiting or downregulating Th17 cells. The combined effects of LPX-TI641's pharmacology enable the adaptive immune system to restore self-tolerance by rebalancing T-reg/Th17 and B-regulatory cells, all without affecting the innate immune system.

Extensive animal models assessing LPX-TI641's efficacy compared to standard treatments have shown positive results in the context of Multiple Sclerosis (MS). These models mimic the current clinical management paradigms for MS, both in terms of treatment escalation and treatment induction/maintenance. Notably, LPX-TI641 demonstrates superior safety profiles as it doesn't induce neutropenia or lymphocytopenia. Currently, LPX-TI641 is being developed for neuro-autoimmune conditions such as MS, with potential expansion into rheumatoid arthritis, lupus, and other autoimmune diseases in the future.

 

Source: globenewswire.com

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