Aevi Genomic Medicine, Inc. Announces Novel Co-crystal Version of AEVI-001
The Company has received feedback from the
Assuming positive results from the ongoing Phase 2 ASCEND clinical trial, and following minimal bridging preclinical and clinical pharmacological studies requested by
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
AEVI-001 is an oral non-stimulant pan selective activator/modulator of mGluRs. The molecule has excellent pharmacokinetic and metabolic profiles and crosses the blood brain barrier.
AEVI-001 is being developed as a potential treatment for a sub-population of Attention Deficit Hyperactivity Disorder (ADHD) patients with genetic mutations that disrupt the mGluR network. In
AEVI-001 is an investigational agent that has not been approved by the US FDA or any other regulatory agencies.
AEVI-004 is an oral non-stimulant pan selective activator/modulator of mGluRs. The molecule has excellent pharmacokinetic and metabolic profiles and crosses the blood brain barrier.
The molecule is a co-crystal of AEVI-001, crystallized with a pharmacologically inert conformer with a favorable toxicological profile. The molecule's pharmacological properties have been designed, and are expected, to be very similar to those of AEVI-001. As such, the Company believes that the molecule may progress directly to phase 3 studies with only minimal bridging preclinical and clinical pharmacological studies.
AEVI-004 has several distinct advantages over AEVI-001, including better stability and better manufacturability owing to a significantly higher melting point.
About Aevi Genomic Medicine, Inc.
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