First patients dosed in clinical trial of small molecule for MS, autoimmune conditions

A Boston-based biopharma company announced the first participants have been dosed in its phase 1 study to assess safety, tolerability and pharmacokinetics of a novel oral, small molecule therapeutic in healthy adults.

According to a release from Lapix Therapeutics Inc, LPX-TI641 is a proprietary first-in-class orally bioavailable therapy designed as a T-cell immunoglobulin and mucin domain-containing protein (Tim) 3/4 receptor agonist in development to treat multiple sclerosis and other autoimmune diseases such as rheumatoid arthritis and lupus.

LPX-TI641’s primary pharmacology is the upregulation of Foxp3+/CD4+ T cells (T regs) and of Tim1+/CD25+/CD19+ (B regs) and inhibition/downregulation of Th17. As a result, LPX-TI641’s pharmacology allows the adaptive immune system to reestablish self-tolerance (T-reg/Th17 balance and B-regs) without affecting the innate immune system, per the release.

The randomized, double-blind, placebo-controlled clinical trial will assess LPX-TI641 after single ascending oral doses, while exploratory pharmacodynamic and biomarker analysis will also be evaluated.

“We are excited to begin the clinical evaluation of our antigen-agnostic immune tolerance restoration therapy,” Lapix co-founder and CEO Anas M. Fathallah, PhD, said in the release. “We look forward to evaluating the therapeutic potential of LPX-TI641 and believe it will be a transformative and safer option for patients suffering from MS and other autoimmune diseases.”