LAPIX Therapeutics Reports Positive Bioequivalence for Oral Capsule and New Safety Milestones in the LPX-TI641 Program

The new oral capsule advances into Phase Ib studies as GLP data establish a new NOAEL, expanding safety margins for LPX-TI641 development.

CAMBRIDGE , MA, UNITED STATES, December 10, 2025 /EINPresswire.com/ -- LAPIX Therapeutics, Inc. (“LAPIX”), a clinical-stage biopharmaceutical company developing first-in-class, orally delivered immune-tolerance-restoring therapies for autoimmune diseases, today announced the successful completion of a bioequivalence study for its lead program LPX-TI641, along with new GLP toxicology results demonstrating an expanded safety margin. The company also confirmed that the optimized capsule formulation has now been introduced into ongoing and planned Phase Ib studies in Rheumatoid Arthritis (RA) and Atopic Dermatitis (AD).

Capsule Formulation Demonstrates Superior Performance to Phase I Liquid Solution

LAPIX has completed a bioequivalence study in healthy human volunteers evaluating the pharmacokinetics and exposure profile of the new solid-dose capsule relative to the Phase I liquid solution. The capsule demonstrated superior performance to the liquid formulation, achieving improved exposure while maintaining a favorable tolerability profile. These results support the capsule as the clinical formulation for all current and planned studies, including the ongoing Phase Ib and upcoming Phase II programs.

16-Week GLP Toxicology Studies Establish 4-Fold Higher NOAEL

In recently completed 16-week GLP toxicology studies, LPX-TI641 achieved a new No Observed Adverse Effect Level (NOAEL) that is four times higher than values observed in earlier studies. This expanded safety window further de-risks clinical development and strengthens the program’s readiness for progression into Phase II studies.

New Capsule Now Implemented in Ongoing RA Study; AD Study Transition Planned

Following the positive bioequivalence data, LAPIX has successfully transitioned patients in its Phase Ib RA study to the new capsule formulation. Implementation of the capsule in the Phase Ib AD study is planned and will be announced upon initiation of patient dosing. The capsule is expected to enhance dosing consistency, improve patient experience, and streamline advancement toward Phase II clinical evaluation.

“These results represent an important set of milestones for LPX-TI641 and for LAPIX as a whole,” said Anas M. Fathallah, Ph.D., Co-Founder and Chief Executive Officer of LAPIX Therapeutics. “The superior performance of the capsule formulation, combined with a significantly expanded safety margin, positions LPX-TI641 strongly as we advance our immune-tolerance approach in autoimmune diseases. We are excited to bring this improved formulation into ongoing patient studies.”

About LPX-TI641
LPX-TI641 is an oral, small-molecule designed to bind 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), psoriasis (PsO) and other autoimmune indications where the underlying pathology involves immune imbalances and loss of self-tolerance. LPX-TI641 aims to re-establish immune balance without broad immunosuppression, offering a differentiated therapeutic approach across autoimmune and inflammatory diseases.

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 commitment to progressive and patient-centric therapies.

Anas M. Fathallah, PhD
LAPIX Therapeutics Inc
info@lapixtherapeutics.com

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