Aevi Genomic Medicine, Inc. Announces Novel Co-crystal Version of AEVI-001
July 19, 2018 at 08:30 am EDT
Aevi Genomic Medicine, Inc. announced that it received positive feedback from the United States Food and Drug Administration (FDA) on an improved version of the Company's lead development molecule, AEVI-001, identified as AEVI-004. Following 2016 U.S. Food and Drug Administration (the FDA) regulatory guidance on co-crystalization of active drugs, the Company created a co-crystal of fasoracetam (AEVI-001) with enhanced physical and chemical properties. The new molecule, AEVI-004, has comparatively greater stability and a higher melting point than AEVI-001. The molecule was engineered to maintain solubility, dissolution and pharmacokinetics substantially similar to AEVI-001. The Company has received feedback from the FDA provisionally indicating that AEVI-004 is a co-crystal of AEVI-001 and a novel drug substance. The FDA also provisionally indicated that existing toxicology and pathology studies can support clinical development with AEVI-004. Assuming positive results from the ongoing Phase 2 ASCEND clinical trial, and following minimal bridging preclinical and clinical pharmacological studies requested by FDA, the Company anticipates progressing the molecule directly into Phase 3 studies with minimal impact on the program timeline. AEVI-004 is expected to have composition of matter patents extending to 2039 and should be listed as a novel drug substance in the FDA Orange Book.