RA cohort fully enrolled with 44 subjects

LAPIX Therapeutics, a clinical-stage biotechnology company developing a novel immunomodulatory therapy for inflammatory and immune-mediated diseases, today announced the completion of enrollment in the rheumatoid arthritis (RA) arm of its ongoing clinical study evaluating LPX-TI641, the Company's lead therapeutic candidate and a first-in-class oral TIM 3/4 agonist.

The RA arm of the study has successfully enrolled all 44 planned subjects across two treatment cohorts. Twenty-four subjects are receiving LPX-TI641 at a dose of 300 mg over a three-month treatment period, while 20 subjects were enrolled in a 150 mg cohort receiving treatment for 28 days. All study participants will continue to undergo protocol-defined follow-up and safety assessments for 60 days following completion of 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 active in the atopic dermatitis (AD) arm of the study. To date, 14 subjects have entered the AD arm and are currently participating in various stages of screening, treatment, and follow-up. The Company continues to work closely with clinical investigators and study sites to complete enrollment and maintain study execution according to protocol.

The ongoing study is designed to evaluate the safety, tolerability, and exploratory measures of biological and clinical activity of LPX-TI641 across multiple inflammatory disease indications. Data generated from both disease cohorts are expected to contribute to the understanding of LPX-TI641's therapeutic potential and support future clinical development decisions.

About LAPIX Therapeutics

LAPIX Therapeutics is a clinical-stage biotechnology company developing next-generation first in class oral TIM 3/4 agonist for autoimmune diseases. The Company’s lead therapeutic is designed to selectively eliminate disease-driving immune cells by increasing Tregs and decreasing Th1/Th17 (and Th2 in diseases such as AD) with the goal of delivering durable remissions and improved outcomes for patients living with chronic autoimmune conditions.

Forward-Looking Statements

This press release contains forward-looking statements regarding LPX-TI641, the ongoing clinical study, enrollment timelines, anticipated clinical development activities, and the potential therapeutic benefits of LPX-TI641. These statements are based on current expectations and are subject to risks and uncertainties inherent in clinical research and drug development. Actual results may differ materially from those expressed or implied by these forward-looking statements. LAPIX Therapeutics undertakes no obligation to update forward-looking statements except as required by applicable law.

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