- LPX-TI641 is a novel, orally bioavailable, potent small-molecule immunomodulator that restores immune tolerance by targeting multiple pathways implicated in autoimmune diseases.
- Topline Phase 1 clinical data for LPX-TI641 in healthy volunteers demonstrated a generally well-tolerated safety profile and exposure-dependent, statistically significant increase in both regulatory T and B cells (T-regs and B-regs) compared to pooled placebo group supporting further development into autoimmune indications.
- LAPIX plans to submit a third IND for LPX-TI641 in the first quarter of 2025 with the dermatology division at the US-FDA.
CAMBRIDGE, MA, USA I January 23, 2025 I 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 the dosing of first subject with its investigational medicine, LPX-TI641, in its Phase 1b clinical trial (NCT06628206). The Phase 1b trial is a randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability, and pharmacokinetics in individuals with moderate-to-severe Rheumatoid Arthritis (RA) and Psoriatic Arthritis (PsA). The Phase 1b study has plans to enroll up to 50 subjects, with topline results anticipated in early 3Q2025.
“Dosing the first subject in this Phase 1b trial marks a significant milestone in advancing the pan-indication potential of LPX-TI641 for serious autoimmune diseases,” said Anas M. Fathallah, Ph.D., co-founder and CEO of LAPIX. “Our basket trial design—evaluating a single drug across multiple indications within a single study—not only accelerates our drug development process but also strengthens our ability to deliver transformative and impactful new treatments that address the diverse group of patients who are diagnosed with autoimmune diseases.”
Autoimmune diseases such as RA and PsA are debilitating conditions that cause joint pain, stiffness, progressive joint damage, and disability. Despite existing treatments and standards of care, 40% of patients do not achieve a minimal response and many either lose response or have adverse effects, underscoring the need for new therapeutic options.
“Conducting this Phase 1b study, as well as the supportive results from the healthy volunteers, are critical steps in advancing our understanding of LPX-TI641’s multi-indication potential,” said Holly Weng, MD lead investigator. “By gathering initial efficacy data and then refining appropriate dosing strategies, we can design more efficient and targeted clinical trials moving forward.”
In 2024, LAPIX announced positive topline data results from its Phase I randomized, double-blind, placebo-controlled single and multiple-ascending (SAD and MAD) trial assessing the safety, tolerability and pharmacokinetics of LPX-TI641 after oral dosing in healthy adult volunteers. The clinical trial results showed LPX-TI641 was generally safe and well tolerated over the tested oral doses from 10 mg to 150 mg in the SAD and up to 120 mg orally once a day for up to 7 days in the MAD portion of the study. Importantly, 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.
About LPX-TI641
LPX-TI641 is an oral, small-molecule currently under clinical development for autoimmune indications such as RA and PsA 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. Additionally, toxicological studies and emerging clinical data show that LPX-TI641 did 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.
SOURCE: Lapix Therapeutics
Post Views: 72
- LPX-TI641 is a novel, orally bioavailable, potent small-molecule immunomodulator that restores immune tolerance by targeting multiple pathways implicated in autoimmune diseases.
- Topline Phase 1 clinical data for LPX-TI641 in healthy volunteers demonstrated a generally well-tolerated safety profile and exposure-dependent, statistically significant increase in both regulatory T and B cells (T-regs and B-regs) compared to pooled placebo group supporting further development into autoimmune indications.
- LAPIX plans to submit a third IND for LPX-TI641 in the first quarter of 2025 with the dermatology division at the US-FDA.
CAMBRIDGE, MA, USA I January 23, 2025 I 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 the dosing of first subject with its investigational medicine, LPX-TI641, in its Phase 1b clinical trial (NCT06628206). The Phase 1b trial is a randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability, and pharmacokinetics in individuals with moderate-to-severe Rheumatoid Arthritis (RA) and Psoriatic Arthritis (PsA). The Phase 1b study has plans to enroll up to 50 subjects, with topline results anticipated in early 3Q2025.
“Dosing the first subject in this Phase 1b trial marks a significant milestone in advancing the pan-indication potential of LPX-TI641 for serious autoimmune diseases,” said Anas M. Fathallah, Ph.D., co-founder and CEO of LAPIX. “Our basket trial design—evaluating a single drug across multiple indications within a single study—not only accelerates our drug development process but also strengthens our ability to deliver transformative and impactful new treatments that address the diverse group of patients who are diagnosed with autoimmune diseases.”
Autoimmune diseases such as RA and PsA are debilitating conditions that cause joint pain, stiffness, progressive joint damage, and disability. Despite existing treatments and standards of care, 40% of patients do not achieve a minimal response and many either lose response or have adverse effects, underscoring the need for new therapeutic options.
“Conducting this Phase 1b study, as well as the supportive results from the healthy volunteers, are critical steps in advancing our understanding of LPX-TI641’s multi-indication potential,” said Holly Weng, MD lead investigator. “By gathering initial efficacy data and then refining appropriate dosing strategies, we can design more efficient and targeted clinical trials moving forward.”
In 2024, LAPIX announced positive topline data results from its Phase I randomized, double-blind, placebo-controlled single and multiple-ascending (SAD and MAD) trial assessing the safety, tolerability and pharmacokinetics of LPX-TI641 after oral dosing in healthy adult volunteers. The clinical trial results showed LPX-TI641 was generally safe and well tolerated over the tested oral doses from 10 mg to 150 mg in the SAD and up to 120 mg orally once a day for up to 7 days in the MAD portion of the study. Importantly, 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.
About LPX-TI641
LPX-TI641 is an oral, small-molecule currently under clinical development for autoimmune indications such as RA and PsA 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. Additionally, toxicological studies and emerging clinical data show that LPX-TI641 did 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.
SOURCE: Lapix Therapeutics
Post Views: 72
