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LAPIX Therapeutics Inc. Receives FDA Approval for Investigational New Drug (IND) Application of LPX-TI641, a Tim3/4 Agonist, in the Treatment of Multiple Sclerosis

Monday, September 18, 2023

LAPIX Therapeutics, Inc., a biopharmaceutical firm dedicated to pioneering novel orally administered therapies for autoimmune disorders, has announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application. This milestone allows the company to move forward with a Phase 1 clinical trial for LPX-TI641, a groundbreaking small molecule designed to restore immune tolerance and treat multiple sclerosis (MS). The clinical trial is scheduled to commence dosing in the fourth quarter of 2023.

Anas M. Fathallah, Ph.D., Chief Executive Officer and co-founder of LAPIX, emphasized their commitment to strengthening the immune system's ability to combat diseases. He noted that the FDA's approval of the LPX-TI641 IND application signifies a significant step forward in their technology and scientific approach. Dr. Fathallah also underscored the potential of LPX-TI641 as a non-immunosuppressive therapeutic option for autoimmune diseases, marking a noteworthy advancement.

The Phase 1 trial's primary objectives are to assess the safety, tolerability, and pharmacokinetics of LPX-TI641 in healthy subjects following a single ascending dose. Data obtained from this Phase 1 study, in conjunction with LPX-TI641's adaptability to various antigens, could pave the way for its use in treating other autoimmune conditions, such as rheumatoid arthritis.

Dr. Fathallah reiterated their dedication to transforming the way the medical community addresses patients dealing with complex immune diseases. Their approach to immune tolerance restoration centers on the development of Tim (T-cell immunoglobulin and mucin domain) agonists, capitalizing on their in-depth knowledge of immunology and immune tolerance to pioneer groundbreaking therapies that also consider patients' quality of life.

LPX-TI641 is an investigational, innovative, and proprietary orally bioavailable small molecule T cell immunoglobulin and mucin domain-containing protein (TIM) 3/4 receptor agonist. The TIM receptor family plays a pivotal role in autoimmunity. LPX-TI641's primary pharmacological actions involve the upregulation of Foxp3+/DC4+ T-cells (T-regs), Tim1+/CD25+/CD19+ (B-regs), and the inhibition/downregulation of Th17. These combined effects of LPX-TI641's pharmacology aim to re-establish self-tolerance in the adaptive immune system (T-reg/Th17 balance and B-regs) without impacting the innate immune system. In several animal models of MS, LPX-TI641's efficacy compared favorably to standard treatments, mimicking the current clinical management paradigms for MS without causing neutropenia or lymphocytopenia. Currently, it is under development for neuro-autoimmune indications like MS, with plans for expansion into treating rheumatoid arthritis and other autoimmune conditions.

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