Categories: News

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

FacebookFacebookTwitterTwitterEmailEmailLinkedInLinkedInWhatsAppWhatsAppMessengerMessengerFlipboardFlipboardGmailGmailTelegramTelegramShareShare

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, Info@lapixtherapeutics.com

 

Staff

Recent Posts

ZEISS Vision Care US Names Healthcare Industry Veteran Gary Rosenblum as President and Chief Executive Officer

Most Recently Serving as President for Oticon, a Division of Demant, Rosenblum Brings 30+ Years…

3 hours ago

TriSalus Life Sciences Announces Commencement of Exchange Offer and Consent Solicitation Relating to Series A Convertible Preferred Stock to Streamline Capital Structure

WESTMINSTER, Colo.--(BUSINESS WIRE)--TriSalus Life Sciences® Inc. (Nasdaq: TLSI), a company working to improve outcomes for…

6 hours ago

As Dangerous US Heat Wave Intensifies, AccuWeather Urges Public to Rely on Science-Backed RealFeel® Temperature for Accurate Danger Index

AccuWeather's RealFeel® Temperature is the only authentic formula-based metric—unlike 'Feels Like,' which lacks scientific credibility.Request…

6 hours ago

New Data Signals IVD Growth in a Shifting Market Amid Tariff Uncertainty

Kalorama Identifies Point-of-Care Testing Momentum and Strategic Blind Spots in Latest Diagnostic Trends Analysis ARLINGTON,…

6 hours ago

Medmovie Hx Heart App Launch Elevates Health Literacy and Empowers Shared Decision Making for Cardiovascular Care

Digital tool equips healthcare providers with trusted visual content to simplify complex heart information at…

6 hours ago

Premera Blue Cross Blue Shield of Alaska Announces Actions to Simplify Prior Authorization Process

Blue Cross and Blue Shield companies aim to improve the prior authorization process to make…

6 hours ago