Metagone Biotech is pleased to announce that its Investigational New Drug Application for MG-S-2525 has been approved by the TFDA on November 16, 2018 and will begin recruitment of healthy volunteers for the Phase 1 study at Tri-Service Hospital in December 2018. Approval of the IND was previously received from the USFDA earlier this year.

　　The active ingredient in MG-S-2525 is a First in Class small molecule kinase inhibitor indicated for Idiopathic Pulmonary Fibrosis (IPF) in-licensed from SMA Therapeutics Inc., of San Diego at the IND-ready stage. The therapeutic target MAP3K19 was discovered by scientists at SMA and represents a novel approach to the treatment of IPF.

　　The full complement of Phase 1 clinical studies for MG-S-2525 will be conducted at Tri-Service Hospital in Taipei, Taiwan and will investigate the safety and tolerability of MG-S-2525 in healthy volunteers. Additionally, biomarkers relevant to IPF and COPD will be evaluated in the multiple-ascending dosing trial arm of the study. Volunteer recruitment will begin in December 2018 and the entire study is anticipated to be completed by end of Q2 2019.

　　IPF is a debilitating disease with no known cure characterized by a progressive, irreversible decline in lung function. While there are 2 approved medications on the market for IPF (Ofev and Esbriet), the therapeutic and side effect profiles of these are such that there remains a high degree of unmet medical need. MG-S-2525, with its novel mechanism of action, is expected to make significant inroads toward filling this need.