Aevi Genomics Medicine receives 'positive' FDA feedback on AEVI-001
Aevi Genomic Medicine announced that it received positive feedback from the United States FDA on an improved version of the company's lead development molecule, AEVI-001, identified as AEVI-004. Following 2016 U.S. 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.