• LPX-TI641 is an oral novel Treg-expanding T cell/transmembrane, immunoglobulin, and mucin(Tim)receptor agonist therapy in development for the treatment of autoimmune diseases such as rheumatoid arthritis, psoriatic arthritis, and multiple sclerosis with the intent to expand into additional therapeutic indications.

• In healthy adults, LPX-TI641 was orally bioavailable and was safe and well tolerated up to the highest tested doses.

• Exploratory pharmacodynamic endpoints showed an exposure-dependent, statistically significant increase in both regulatory T and B cells (T-regs and B-regs) compared to pooled placebo group.

• LAPIX cleared a second Investigational New Drug (IND) for LPX-TI641 with the rheumatology division at the US-FDA.

• LAPIX will initiate a Phase 1b study for Rheumatoid arthritis (RA) in Q4 2024.

BOSTON, November 20, 2024 (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 positive topline results from its Phase I randomized, double-blind, placebo-controlled single and multiple-ascending dose (SAD and MAD) trial to assess the safety, tolerability, and pharmacokinetics (PK) of LPX-TI641 after oral dosing in healthy adult volunteers, LPX641-101 (NCT05853835).

The Phase 1 clinical trial results showed LPX-TI641 to be safe and well tolerated over the course of the tested oral doses from 10 mg to 150 mg in the SAD, and 30 mg to 120 mg once daily oral doses for up to 7 days in the MAD portion of the trial. A maximum tolerated dose was not identified in this trial. Adverse events were primarily mild and were sporadically observed across both placebo and treatment groups and not linked to dosage levels. Mild headaches were the most reported adverse event. Notably, treatment-emergent neutropenia and lymphocytopenia - two of the most common side effects associated with autoimmune therapies - were absent in subjects administered various doses of LPX-TI641.

"We are committed to innovating around the complexities of the immune system,” said Anas M. Fathallah, Ph.D., co-founder and CEO of LAPIX. “The emerging preliminary data, particularly the observed exposure dependent changes in our key exploratory biomarkers, T-regs and B-regs, highlight LPX-TI641’s potential as a leading therapy for autoimmune disease. We are eager to advance this promising candidate into a Phase Ib study in RA and PsA and create a potential new oral standard of care for patients battling autoimmune diseases.”

LPX-TI641 demonstrated oral bioavailability with a dose-dependent increase in exposure at higher doses. Preliminary exploratory pharmacodynamic data from the study revealed an LPX-TI641 exposure dependent and statistically significant increase in circulating CD4+/Foxp3+ T-cells (T-regs) and CD25+/CD19+ B-cells (B-regs) compared to pooled placebo group.

The Phase I clinical trial utilized six SAD and three MAD cohorts. A total of 72 subjects (eight subjects per cohort, six on active treatment and two on placebo) were enrolled consecutively in the study. Out of the 72 subjects, 70 completed all scheduled study activities and visits. Two subjects withdrew from the study for personal reasons conflicting with study activities, unrelated to drug adverse effects.

About LPX-TI641
LPX-TI641 is an oral, small-molecule designed to bind the phosphatidylserine binding pocket on the T cell/transmembrane, immunoglobulin, and mucin (Tim) family of receptors. It is currently under clinical development for autoimmune indications such as rheumatoid arthritis (RA), psoriatic arthritis (PsA) and multiple sclerosis with plans to expand to other autoimmune indications where the underlying pathology involves immune imbalances and loss of self-tolerance.

LPX-TI641’s primary pharmacology works to restore the adaptive immune system’s self-tolerance rather than suppressing immunity, enabling patients to more effectively and gently combat autoimmune disease. Toxicological studies and emerging clinical data show that LPX-TI641 does not induce neutropenia or lymphocytopenia, suggesting a potentially improved safety profile compared to current therapies.

About LAPIX Therapeutics
LAPIX Therapeutics is a Cambridge, MA-based clinical-stage biopharmaceutical company focused on developing novel, first in class, oral immune system restoration therapeutics for the treatment of autoimmune diseases. Our scientific approach to developing Tim agonists (T-cell immunoglobulin and mucin domain) and restoring the natural immune tolerance pathway with potent small molecules reflects our passion for progressive and patient-centric approaches.

Contact
Anas M. Fathallah, Ph.D.
CEO and Co-Founder
[email protected]