LAPIX Therapeutics, a clinical-stage biopharmaceutical company, has commenced a Phase 1b clinical trial (NCT06628206) of LPX-TI641, a novel, orally bioavailable small-molecule immunomodulator, in patients with moderate-to-severe Rheumatoid Arthritis (RA) and Psoriatic Arthritis (PsA). The first patient has been dosed in this randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and pharmacokinetics of LPX-TI641.
The Phase 1b trial plans to enroll up to 50 subjects, with topline results anticipated in early 3Q2025. The trial's design allows for the evaluation of LPX-TI641 across multiple indications within a single study, potentially accelerating the drug development process.
LPX-TI641: Restoring Immune Tolerance
LPX-TI641 is designed to restore immune tolerance by targeting multiple pathways implicated in autoimmune diseases. Its primary mechanism of action focuses on restoring the adaptive immune system’s self-tolerance rather than broadly suppressing immunity. Preclinical and early clinical data suggest a potentially improved safety profile compared to current therapies, with no observed treatment-emergent neutropenia or lymphocytopenia in healthy volunteers.
Prior Clinical Data
In 2024, LAPIX announced positive topline data from a Phase 1 randomized, double-blind, placebo-controlled single and multiple-ascending dose (SAD and MAD) trial in healthy adult volunteers. The results indicated that LPX-TI641 was generally safe and well-tolerated across oral doses ranging from 10 mg to 150 mg in the SAD portion and up to 120 mg once daily for seven days in the MAD portion of the study. The trial also demonstrated a statistically significant increase in regulatory T and B cells (T-regs and B-regs) compared to the placebo group.
The Need for New Therapies
Autoimmune diseases like RA and PsA affect millions worldwide, causing joint pain, stiffness, progressive joint damage, and disability. Despite available treatments, a significant proportion of patients, approximately 40%, do not achieve a minimal response, and many experience adverse effects or loss of response over time, highlighting the need for new therapeutic options.
Management Commentary
"Dosing the first subject in this Phase 1b trial marks a significant milestone in advancing the pan-indication potential of LPX-TI641 for serious autoimmune diseases," said Anas M. Fathallah, Ph.D., co-founder and CEO of LAPIX. Holly Weng, MD, the lead investigator, added, "Conducting this Phase 1b study, as well as the supportive results from the healthy volunteers, are critical steps in advancing our understanding of LPX-TI641’s multi-indication potential."
LAPIX Therapeutics plans to submit a third IND for LPX-TI641 in the first quarter of 2025 with the dermatology division at the US-FDA, signaling further commitment to expanding the drug's potential applications.
