LPX-TI641 / LAPIX Therap - LARVOL DELTA

LPX-TI641, a Tim3/4 Agonist, Induces Long-Term Immune Tolerance in Multiple Sclerosis Models. (PubMed, Pharmaceutics) - "Efficacy in animal models was comparable to or exceeded that of high-efficacy DMTs, including natalizumab. LPX-TI641 promotes antigen-independent immune tolerance through Tim receptor agonism and Treg expansion. These findings support its potential as a novel therapeutic candidate for MS, addressing the limitations of current DMTs."

Journal • CNS Disorders • Immunology • Multiple Sclerosis • CD4 • FOXP3 • HAVCR2

Safety and Pharmacokinetics of LPX-TI641 in Rheumatoid Arthritis and Psoriatic Arthritis (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: LAPIX Therapeutics Inc. | Trial primary completion date: Sep 2025 ➔ Dec 2025

Trial primary completion date • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Safety and Pharmacokinetics of LPX-TI641 in Atopic Dermatitis and Psoriasis (clinicaltrials.gov) - P1 | N=48 | Active, not recruiting | Sponsor: LAPIX Therapeutics Inc. | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Psoriasis

Safety and Pharmacokinetics of LPX-TI641 in Atopic Dermatitis and Psoriasis (clinicaltrials.gov) - P1 | N=48 | Not yet recruiting | Sponsor: LAPIX Therapeutics Inc.

New P1 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Psoriasis

Safety and Pharmacokinetics of LPX-TI641 in Rheumatoid Arthritis and Psoriatic Arthritis (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: LAPIX Therapeutics Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies

First-in-Human Trial in Healthy Adult Volunteers to Evaluate Safety, Tolerability and PK of LAPIX Study Drug; LPX-TI641 (clinicaltrials.gov) - P1 | N=72 | Completed | Sponsor: LAPIX Therapeutics Inc. | Recruiting ➔ Completed

Trial completion • CNS Disorders • Immunology • Multiple Sclerosis

LAPIX Therapeutics Doses First Patient-In Phase 1b Clinical Trial of LPX-TI641 for Rheumatoid Arthritis (RA) and Psoriatic Arthritis (PsA) (GlobeNewswire) - "LAPIX Therapeutics, Inc...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."

P1 data • Trial status • Psoriatic Arthritis • Rheumatoid Arthritis

LAPIX Therapeutics Announces Positive Topline Phase 1 Clinical Data Results with LPX-TI641 for the Treatment of Autoimmune Diseases (GlobeNewswire) - P1 | N=72 | NCT05853835 | Sponsor: LAPIX Therapeutics Inc. | "The Phase 1 clinical trial results showed LPX-TI641 to be safe and well tolerated over the course of the tested oral doses from 10 mg to 150 mg in the SAD, and 30 mg to 120 mg once daily oral doses for up to 7 days in the MAD portion of the trial. A maximum tolerated dose was not identified in this trial. Adverse events were primarily mild and were sporadically observed across both placebo and treatment groups and not linked to dosage levels....LPX-TI641 demonstrated oral bioavailability with a dose-dependent increase in exposure at higher doses. Preliminary exploratory pharmacodynamic data from the study revealed an LPX-TI641 exposure dependent and statistically significant increase in circulating CD4+/Foxp3+ T-cells (T-regs) and CD25+/CD19+ B-cells (B-regs) compared to pooled placebo group....LAPIX will initiate a Phase 1b study for Rheumatoid arthritis (RA) in Q4 2024."

New P1 trial • P1 data • PK/PD data • Multiple Sclerosis • Rheumatoid Arthritis

Safety and Pharmacokinetics of LPX-TI641 in Rheumatoid Arthritis and Psoriatic Arthritis (clinicaltrials.gov) - P1 | N=50 | Not yet recruiting | Sponsor: LAPIX Therapeutics Inc.

New P1 trial • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies

First-in-Human Trial in Healthy Adult Volunteers to Evaluate Safety, Tolerability and PK of LAPIX Study Drug; LPX-TI641 (clinicaltrials.gov) - P1 | N=72 | Recruiting | Sponsor: LAPIX Therapeutics Inc. | N=48 ➔ 72 | Trial completion date: Aug 2024 ➔ Nov 2024 | Trial primary completion date: Apr 2024 ➔ Aug 2024

Enrollment change • Trial completion date • Trial primary completion date • CNS Disorders • Immunology • Multiple Sclerosis

First-in-Human Trial in Healthy Adult Volunteers to Evaluate Safety, Tolerability and PK of LAPIX Study Drug; LPX-TI641 (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: LAPIX Therapeutics Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Immunology • Multiple Sclerosis

LAPIX Therapeutics Inc. Announces FDA Clearance of IND Application for its Treg-expanding Tim3/4 Agonist LPX-TI641 to Treat Multiple Sclerosis (GlobeNewswire) - "LAPIX Therapeutics, Inc...today announced that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 clinical trial for its first-in-class, immune tolerance restoration small molecule, LPX-TI641, for the treatment of multiple sclerosis (MS). The clinical trial is expected to begin dosing in 4Q 2023."

IND • New P1 trial • Immunology • Multiple Sclerosis

First-in-Human Trial in Healthy Adult Volunteers to Evaluate Safety, Tolerability and PK of LAPIX Study Drug;LPX-TI641 (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: LAPIX Therapeutics Inc. | Trial completion date: Mar 2024 ➔ Aug 2024 | Trial primary completion date: Dec 2023 ➔ Apr 2024

Trial completion date • Trial primary completion date • CNS Disorders • Immunology • Multiple Sclerosis

LAPIX Therapeutics Inc. Announces the Issuance of U.S. Patent for LPX-TI641, Its First-in-Class, Orally Administered Tim3/4 Agonist for Treg Expansion to Treat Autoimmune Diseases (GlobeNewswire) - "LAPIX Therapeutics...today announced the U.S. Patent & Trademark Office issued its U.S. Patent No. 11,648,225, entitled 'Compositions And Methods For Reducing Immune Intolerance And Treating Autoimmune Disorders.' The patent is directed to LPX-TI641, LAPIX’s novel, first-in-class, immune tolerance restoration small molecule. LPX-TI641 has been purposefully designed to be a Tim3 and Tim4 agonist that can restore the regulatory T cell (Treg) population in an antigen-agnostic manner for treating autoimmune diseases. LPX-TI641 is currently under development for neuro-autoimmune indications such as multiple sclerosis (MS) with the intent of expanding to other indications and is expected to begin Phase I enrollment in July 2023."

New P1 trial • Patent • Immunology • Multiple Sclerosis

First-in-Human Trial in Healthy Adult Volunteers to Evaluate Safety, Tolerability and PK of LAPIX Study Drug;LPX-TI641 (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: LAPIX Therapeutics Inc.

New P1 trial • CNS Disorders • Immunology • Multiple Sclerosis