LAPIX Therapeutics Inc. Announces a Successful Conclusion of its Pre-IND Meeting Request with the U.S. FDA

Excerpt from the Press Release:

BOSTON, Jan. 26, 2023 (GLOBE NEWSWIRE) — LAPIX Therapeutics, Inc. (“LAPIX”), a biopharma company focused on developing novel, orally bioavailable immune system restoration therapies for autoimmune diseases and oncology, today announced the successful outcome of its pre-IND meeting request with the U.S. Food and Drug Administration (FDA). The meeting’s objective was to achieve alignment with the FDA on LAPIX’s IND-enabling plan for its novel, first-in-class, immune tolerance restoration small molecule, LPX-TI641_, under development for neuro-autoimmune indications such as multiple sclerosis (MS), Neuromyelitis Optica Spectrum Disorders (NMOSD), and Myelin Oligodendrocyte Glycoprotein Antibody Disease (MOGAD).

LAPIX’s pre-IND drug candidate, LPX-TI641, is an orally bioavailable, antigen-agnostic, immune tolerance restoration small molecule that can restore the regulatory T cell/T helper type 17 cell (Treg/Th17) imbalance associated with autoimmune diseases such as MS. LPX-TI641 is supported by a robust body of preclinical data and has shown a favorable safety profile and superior efficacy to current standards of care in several non-clinical, experimental autoimmune encephalomyelitis (EAE) models 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,” said Anas M. Fathallah, Ph.D., President, and Co-founder of LAPIX.

Click the button below to read the entire Press Release:

Continue Reading The Press Release