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

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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).

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星期四, 一月 26, 2023

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Tags:

MS, Food, Multiple sclerosis, Immune system, Spectrum disorder, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, FDA, Neuro, NMOSD, EAE, MOGAD, Immune tolerance, Degenerative disease, Therapy, Pharmaceutical industry, Vaccine

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BOSTON, MA, US

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LAPIX THERAPEUTICS

摘要

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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).
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.
“The outcome of this meeting request supports LAPIX’s IND-enabling plan and we now have a path forward to the clinic.”

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. “The outcome of this meeting request supports LAPIX’s IND-enabling plan and we now have a path forward to the clinic.”

About LAPIX Therapeutics

LAPIX Therapeutics Inc. is a Boston, MA-based company in the biopharma sector, focused on developing novel, orally bioavailable immune system restoration therapies, including immune tolerance restoration therapy for autoimmune diseases, immune tolerance induction therapies for gene therapy and enzyme replacement therapy, and immune function restoration therapies for oncology. To learn more, visit lapixtherapeutics.com or follow us on LinkedIn.

Contact: Anas M. Fathallah, Ph.D. CEO and Co-Founder, [email protected]