US patent secured for experimental LPX-TI641 for autoimmune diseases

LAPIX Therapeutics has secured a new U.S. patent covering the use of its experimental oral therapy LPX-TI641 as a means to restore immune tolerance in people with autoimmune diseases such as multiple sclerosis (MS).

Issued by the U.S. Patent and Trademark Office with the number 11,648,225, the patent is titled “Compositions And Methods For Reducing Immune Intolerance And Treating Autoimmune Disorders.”

LAPIX is currently developing its novel, first-in-class small molecule for neuro-autoimmune conditions such as MS, neuromyelitis optica spectrum disorder, and myelin oligodendrocyte glycoprotein antibody disease, but is planning to expand to rheumatic conditions in the future.

Enrollment for a first-in-human Phase 1 clinical trial is expected to start in July.

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‘Very promising for the treatment of autoimmune diseases in general’

“This is very promising for the treatment of autoimmune diseases in general and MS in particular,” Anas M. Fathallah, PhD, CEO and co-founder of LAPIX, said in a company press release.

“The issuance of this patent marks a significant step towards creating a new patient-centric standard of care that restores the immune system to its natural state without the immune system wrecking ball approach of many other autoimmune treatments,” he added.

MS is caused by the immune system mistakenly attacking the myelin sheath, a protective coating around nerve fibers that protects cells and ensures effective communication between them. This inflammatory attack usually happens because the immune system fails to recognize the body’s own proteins, a dysfunction of a process called immune tolerance, and mounts a response against them.

Notably, the loss of immune tolerance is typically accompanied by an increase in inflammatory T-cells, associated with inflammatory processes responsible for perpetuating autoimmune responses, and a reduction in regulatory T-cells (Tregs), which dampen uncontrolled immune responses and contribute to immune tolerance.

LPX-TI641 is a small molecule designed to activate the Tim3 and Tim4 receptors, which are found at the surface of immune cells, to boost the expansion of Tregs and restore normal numbers of this immune cell population.

This allows the immune system to restore the imbalance between regulatory and inflammatory T-cells, without suppressing the part of the immune system that’s needed to fight infections, and, thereby, re-establishing immune tolerance.

It may offer an alternative to the traditional approaches to treating autoimmune diseases, which frequently involve immune suppressive therapies that may lead to impaired immune responses and persistent infections.

Extensive preclinical data have demonstrated that LPX-TI641 alone is more effective than current MS therapies, both during treatment escalation and induction and maintenance scenarios. The findings support LPX-TI641 as a potentially safe and effective medication for controlling aggressive disease.

“Treating autoimmune diseases by re-establishing self-tolerance … with an orally administered therapeutic is a new approach that will unleash the power of immune tolerance,” Fathallah said.