LAPIX Therapeutics Doses First Patient-In Phase 1b Clinical Trial of LPX-TI641 for Rheumatoid Arthritis (RA) and Psoriatic Arthritis (PsA)

• LPX-TI641 is a novel, orally bioavailable, potent small-molecule immunomodulator that restores immune tolerance by targeting multiple pathways implicated in autoimmune diseases.
• Topline Phase 1 clinical data for LPX-TI641 in healthy volunteers demonstrated a generally well-tolerated safety profile and exposure-dependent, statistically significant increase in both regulatory T and B cells (T-regs and B-regs) compared to pooled placebo group supporting further development into autoimmune indications.
• LAPIX plans to submit a third IND for LPX-TI641 in the first quarter of 2025 with the dermatology division at the US-FDA.

Excerpt from the Press Release:

CAMBRIDGE, Mass., Jan. 23, 2025 (GLOBE NEWSWIRE) — LAPIX Therapeutics, Inc. (“LAPIX”), a clinical-stage biopharmaceutical company focused on developing novel, orally bioavailable immune system restoration therapies for autoimmune diseases based on agonism of TIM (T cell/transmembrane, immunoglobulin, and mucin receptor), today announced the dosing of first subject with its investigational medicine, LPX-TI641, in its Phase 1b clinical trial (NCT06628206). The Phase 1b trial is a randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability, and pharmacokinetics in individuals with moderate-to-severe Rheumatoid Arthritis (RA) and Psoriatic Arthritis (PsA). The Phase 1b study has plans to enroll up to 50 subjects, with topline results anticipated in early 3Q2025.

“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. “Our basket trial design—evaluating a single drug across multiple indications within a single study—not only accelerates our drug development process but also strengthens our ability to deliver transformative and impactful new treatments that address the diverse group of patients who are diagnosed with autoimmune diseases.”

Autoimmune diseases such as RA and PsA are debilitating conditions that cause joint pain, stiffness, progressive joint damage, and disability. Despite existing treatments and standards of care, 40% of patients do not achieve a minimal response and many either lose response or have adverse effects, underscoring the need for new therapeutic options.

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