LAPIX Therapeutics Reports Positive Phase 1 Results for LPX-TI641 in Autoimmune Disease Treatment

LAPIX Therapeutics, Inc. has revealed positive results from a Phase I clinical trial assessing the oral drug LPX-TI641. This clinical-stage biopharmaceutical firm, known for creating novel immune system restoration therapies, focuses on autoimmune diseases. LPX-TI641 is a cutting-edge treatment targeting the Tim receptor family to enhance therapeutic outcomes in conditions such as rheumatoid arthritis, psoriatic arthritis, and multiple sclerosis.

The Phase I trial, identified as LPX641-101 (NCT05853835), was a randomized, double-blind, placebo-controlled study involving single and multiple-ascending dose (SAD and MAD) evaluations. Conducted on healthy adult volunteers, it aimed to determine the safety, tolerability, and pharmacokinetics of LPX-TI641. The trial consisted of various oral doses, ranging from 10 mg to 150 mg for the SAD portion and 30 mg to 120 mg daily for up to seven days for the MAD portion.

Notably, the results indicated that LPX-TI641 is both safe and well-tolerated. No maximum tolerated dose was identified, and the adverse events reported were mostly mild with no clear correlation to dosage. Mild headaches were the most common adverse event, while more severe side effects like neutropenia and lymphocytopenia, typical in autoimmune therapies, were not observed in subjects taking LPX-TI641.

Dr. Anas M. Fathallah, co-founder and CEO of LAPIX, expressed enthusiasm about the drug's potential, particularly highlighting its ability to induce exposure-dependent changes in key exploratory biomarkers, T-regs and B-regs. These findings suggest LPX-TI641 could become a leading oral therapy for autoimmune diseases. LAPIX plans to advance the drug to Phase Ib studies for rheumatoid arthritis and psoriatic arthritis, aiming for a new standard of care in autoimmune treatments.

The pharmacodynamic data from this trial showed that LPX-TI641 displays dose-dependent oral bioavailability, with higher doses correlating with increased exposure. Furthermore, the study revealed a significant increase in circulating CD4+/Foxp3+ T-cells (T-regs) and CD25+/CD19+ B-cells (B-regs) in subjects administered LPX-TI641 compared to the placebo group, demonstrating the drug's potential to positively modulate the immune system.

The trial included six SAD and three MAD cohorts, enrolling a total of 72 subjects. Each cohort had eight participants, with six receiving the active treatment and two on placebo. Of these, 70 subjects completed all study activities and visits, while two withdrew due to personal reasons unrelated to the drug.

LPX-TI641 is a small-molecule designed to bind specifically to the phosphatidylserine binding pocket on Tim receptors, which play a crucial role in maintaining immune balance. By enhancing self-tolerance within the adaptive immune system, LPX-TI641 offers a potential advantage over existing therapies that often suppress immunity.

Toxicological studies and emerging clinical data indicate that LPX-TI641 does not cause neutropenia or lymphocytopenia, suggesting a safer profile compared to current treatments. By aiming to restore natural immune tolerance rather than merely suppressing immune responses, LPX-TI641 provides a promising and gentler approach for patients combatting autoimmune diseases.

Based in Cambridge, MA, LAPIX Therapeutics continues to push the boundaries with its innovative scientific approach, developing first-in-class therapies that focus on immune system restoration. The company’s commitment to patient-centric solutions reflects its dedication to advancing treatments for autoimmune diseases.

The results of this Phase I trial mark a significant milestone for LAPIX Therapeutics as they prepare to further investigate LPX-TI641 in subsequent clinical phases.