BOSTON, MA, USA I November 07, 2023 I LAPIX Therapeutics, Inc. (“LAPIX”), a biopharmaceutical company focused on developing novel, orally bioavailable immune system restoration therapies for autoimmune diseases, today announced that the first participants have been dosed in the Phase 1 study of the Company’s LPX-TI641therapy.

LPX-TI641 is a novel, and proprietary first-in-class orally bioavailable small molecule designed as a T cell immunoglobulin and mucin domain-containing protein (Tim) 3/4 receptor agonist. The Tim family of receptors plays an important role in autoimmunity. LPX-TI641 restores the balance of regulatory immune cells (T- and B-regs) to autoreactive T-cells reestablishing immune tolerance. It is being developed for the treatment of Multiple Sclerosis (MS) and potentially other autoimmune diseases such as rheumatoid arthritis and lupus.

“The dosing of the first participants is a major milestone in the clinical development of LPX-TI641,” said Anas M. Fathallah, Ph.D., Chief Executive Officer and co-founder of LAPIX. “We are excited to begin the clinical evaluation of our antigen-agnostic immune tolerance restoration therapy. We look forward to evaluating the therapeutic potential of LPX-TI641 and believe it will be a transformative and safer option for patients suffering from MS and other autoimmune diseases. The design of the Phase I study will allow us the flexibility to leverage the clinical data for other indications, enabling rapid pivots into other autoimmune diseases,” added Dr. Fathallah.  

The study is a randomized, double-blind, placebo-controlled study in healthy adult volunteers to evaluate the safety, tolerability, and pharmacokinetics of LPX-TI641 after single ascending oral doses. Exploratory pharmacodynamic and biomarker analysis will also be evaluated as part of this study. More information about the study can be found at NCT05853835

About LPX-TI641

LPX-TI641’s primary pharmacology is the upregulation of Foxp3+/CD4+ T-cells (T-regs) and of Tim1+/CD25+/CD19+ (B-regs) and inhibition/downregulation of Th17. The combined effects of LPX-TI641’s pharmacology is to allow the adaptive immune system to re-establish self-tolerance (T-reg/Th17 balance and B-regs) without affecting the innate immune system.

The efficacy of LPX-TI641 versus standards of care has been evaluated in several animal models of MS and those models have shown favorable efficacy of LPX-TI641 in treatment escalation and treatment induction/maintenance paradigms mimicking current clinical management paradigms of MS without inducing neutropenia or lymphocytopenia suggesting better safety as well. It is currently under development for neuro-autoimmune indications such as MS, with the intent to expand into rheumatoid arthritis and lupus amongst other autoimmune conditions.

About LAPIX Therapeutics

LAPIX Therapeutics Inc. is a Boston, MA-based company in the biopharma sector, focused on developing novel, orally bioavailable immune system restoration therapies, including immune tolerance restoration therapy for autoimmune diseases, immune tolerance induction therapies for gene therapy, and immune function restoration therapies for oncology. To learn more, visit or follow us on LinkedIn and X.

SOURCE: LAPIX Therapeutics