Aevi Genomic Medicine has 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 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.

"The successful engineering of the co-crystal molecule AEVI-004 provides great flexibility in the further development of fasoracetam for ADHD and other glutamate receptor-linked neuropsychiatric diseases," said Garry A. Neil, M.D., Chief Scientific Officer of the company. "We are proud of the work done by our R&D team to develop AEVI-004, and we will continue to work closely with the FDA as we look to progress this molecule into Phase 3 studies. We look forward to presenting topline data from the ongoing Phase 2 ASCEND trial in the fourth quarter of this year."

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