**Encouraging News from LAPIX Therapeutics**
LAPIX Therapeutics, Inc., a company specializing in innovative oral treatments aimed at restoring immune system balance in autoimmune disorders, has announced promising initial findings from their phase 1 trial. This study was a randomized, double-blind, placebo-controlled trial that incorporated single and multiple-ascending dose methods (SAD and MAD) to evaluate the safety, tolerability, and pharmacokinetics of oral LPX-TI641 in healthy adult participants (Trial Identifier: NCT05853835).
**Trial Highlights**
The phase 1 trial results revealed that LPX-TI641 is safe and well-tolerated over various tested oral doses ranging from 10 mg to 150 mg in the SAD section, and 30 mg to 120 mg daily for a week in the MAD section, with no maximum tolerated dose identified. Any adverse effects observed were mild and occurred infrequently in both placebo and treatment groups, without any direct association with dosage levels. Headaches were the most common mild adverse event reported. Critically, there were no instances of treatment-related neutropenia or lymphocytopenia, common side effects associated with autoimmune therapies, in subjects who received LPX-TI641.
“Our dedication to deciphering the immune system’s intricacies remains unwavering,” stated Anas M. Fathallah, Ph.D., co-founder and CEO of LAPIX. “The preliminary data, especially the dose-related shifts in key biomarkers such as T-regs and B-regs, suggests LPX-TI641 could become a leading therapy for autoimmune diseases. We are eager to advance this candidate into a phase Ib trial targeting RA and PsA, aiming to set a new oral treatment benchmark for autoimmune conditions.”
**Study Insights**
LPX-TI641 exhibited oral bioavailability with increased exposure observed at higher doses. Initial pharmacodynamic insights from the trial indicated a dose-dependent and statistically significant rise in circulating CD4+/Foxp3+ T-cells (T-regs) and CD25+/CD19+ B-cells (B-regs) when compared to the pooled placebo group.
**Trial Design and Completion**
The phase 1 trial used multiple SAD and MAD cohorts. A total of 72 subjects, each assigned to either active treatment or placebo across six SAD and three MAD cohorts, participated. Of these, 70 subjects completed the trial without issues, with only two withdrawing for personal reasons unrelated to any drug side effects.
**About LPX-TI641**
LPX-TI641, an oral small molecule formulated to target the phosphatidylserine pocket on T cell/transmembrane, immunoglobulin, and mucin (Tim) receptors, is advancing through clinical development for autoimmune diseases like rheumatoid arthritis, psoriatic arthritis, and multiple sclerosis. Further expansion to other conditions involving immune system imbalance and self-tolerance disruption is planned. The primary aim of LPX-TI641 is to reinstate immune system self-tolerance without immune suppression, offering patients a potentially safer alternative to existing therapies. Toxicological evaluations and ongoing clinical data suggest a favorable safety profile as LPX-TI641 shows no evidence of inducing neutropenia or lymphocytopenia.