LAPIX, FDA Meeting Sets Way for LPX-TI641 Clinical Development

Lapix Therapeutics has met with the U.S. Food and Drug Administration (FDA) to determine how to advance its investigational treatment candidate LPX-TI641 into clinical trials for autoimmune diseases such as multiple sclerosis (MS).

The pre-investigational new drug (pre-IND) meeting is usually the first formal one companies seeking to bring a drug to the market have with the FDA. It gives drug developers the opportunity to discuss their plans and align them with the expectations and requirements for a future IND application to request clearance for clinical trial initiation.

“The outcome of this meeting request supports Lapix’s IND-enabling plan and we now have a path forward to the clinic,” said Anas M. Fathallah, PhD, president, and co-founder of Lapix, in a company press release.

In MS, the immune system launches a misguided attack against myelin, the protective cover around nerve fibers that helps them transmit electric impulses more rapidly. There are many immune alterations that contribute to the autoimmune attack in MS. One is an imbalance between the number of pro-inflammatory T-cells and immunosuppressive regulatory T-cells (Tregs).

While pro-inflammatory T helper 17 cells, also known as Th17 cells, contribute to myelin damage, Tregs help keep the immune system in check, dampening excessive immune and inflammatory responses.

LPX-TI641 is an orally available small molecule designed to normalize that imbalance and restore immune tolerance — the immune system’s ability to tolerate “self” molecules and mount an attack against “non-self” molecules. This is a process that goes awry in MS and other autoimmune diseases.

According to Lapix, LPX-TI641, its lead candidate, has shown a favorable safety profile and superior effectiveness compared with standard of care approaches used in animals with experimental autoimmune encephalomyelitis, which is commonly used as a rodent model of MS.

“As a high-efficacy, non-immune suppressive compound with a projected favorable safety profile, LPX-TI641 is expected to fill a clear unmet need in the current MS treatment landscape. We also expect it to be safe enough for early and long-term use,” Fathallah said.

LPX-TI641 also is being developed for other autoimmune diseases, including neuromyelitis optica spectrum disorders (NMOSD) and myelin oligodendrocyte glycoprotein antibody disease (MOGAD), both of which also feature an inflammatory attack that damages the myelin sheath.