CAMBRIDGE, Mass. — LAPIX Therapeutics has completed enrollment in the rheumatoid arthritis arm of an ongoing clinical study evaluating LPX-TI641, its lead therapeutic candidate and a first-in-class oral TIM 3/4 agonist.
The clinical-stage biotechnology company is developing LPX-TI641 as an immunomodulatory therapy for inflammatory and immune-mediated diseases.
The rheumatoid arthritis arm enrolled all 44 planned participants across two treatment cohorts. One cohort includes 24 participants receiving a 300 mg dose of LPX-TI641 over a three-month treatment period. The second cohort includes 20 participants receiving a 150 mg dose for 28 days.
All participants will undergo protocol-defined follow-up and safety assessments for 60 days after completing treatment.
“Completion of enrollment in the rheumatoid arthritis arm represents an important milestone in the clinical development of LPX-TI641,” said Anas Fathallah, CEO of LAPIX Therapeutics. “As a first-in-class TIM 3/4 agonist, LPX-TI641 was designed to restore immune homeostasis through a differentiated mechanism that has the potential to address a broad range of inflammatory diseases. We are encouraged by the progress of the study and look forward to advancing enrollment in the atopic dermatitis arm while continuing to generate clinical data that will inform the future development of the program.”
Enrollment remains underway in the study’s atopic dermatitis arm. LAPIX said 14 participants have entered that portion of the study and are in various stages of screening, treatment and follow-up.
The company said it is continuing to work with clinical investigators and study sites to complete enrollment and conduct the trial according to its protocol.
The ongoing study is evaluating the safety and tolerability of LPX-TI641, along with exploratory measures of its biological and clinical activity across multiple inflammatory disease indications.
Data from the rheumatoid arthritis and atopic dermatitis cohorts are expected to help assess the therapeutic potential of LPX-TI641 and guide future clinical development decisions.
