Aevi Genomic Medicine Announces Capital Raise of $4.9M to Accelerate Part B of the ASCEND Trial
- The Company recently announced the completion of enrollment in Part A of the ASCEND trial and intends to use the net proceeds raised from the ATM to accelerate Part B of the ASCEND trial.
- Enrollment in Part B of the ASCEND trial has been initiated and will study patients without mGluR mutations.
- The Company has approximately 1,500 mGluR mutation negative patients in the ASCEND database from which it can enroll patients for Part B of the study.
- Pooled analysis of Part A and Part B of the ASCEND trial will also be conducted, if appropriate. A pooled analysis may provide greater power and enhance the ability to detect a smaller treatment effect.
- The Company currently anticipates top-line data for Parts A and B of the ASCEND trial during the fourth quarter of 2018.
"We are pleased to be in a position to accelerate Part B of the ASCEND trial. AEVI-004 increases the importance and potential value of Part B of the ASCEND trial as it allows for long patent protection for treating all ADHD patients. mGluR mutation negative patients make up approximately 75-80% of the approximately
The shares of common stock sold through the Company's ATM program have been issued and sold pursuant to the Company's shelf registration statement on Form S-3 (File No. 333-209737), previously filed with the
About the ASCEND Clinical Trial
ASCEND is an adaptive, 6-week, double-blind parallel-group study in children and adolescents (ages 6-17 years) with ADHD with and without copy number variants (CNVs) in specific genes implicated in glutamatergic signaling and neuronal connectivity. Part A includes subjects determined to have one of eight specific gene mutation(s) implicated in glutamatergic signaling and neuronal connectivity. Part B will assess subjects who do not have CNVs in any of the specific gene mutation(s) implicated in glutamatergic signaling and neuronal connectivity. Once subjects are confirmed as eligible for each part of the study, they are randomized to one of two treatment groups (AEVI-001 or placebo) in a 1:1 ratio.
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.
The Company is developing AEVI-001 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
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.
AEVI-004 is an investigational agent that has not been approved by the
About Aevi Genomic Medicine, Inc.
This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995, which include all statements other than statements of historical fact, including (without limitation) those regarding the Company's financial position, status and timing of clinical trials, its development and business strategy, its product candidates and the plans and objectives of management for future operations and future financings. The Company intends that such forward-looking statements be subject to the safe harbors created by such laws. Forward-looking statements are sometimes identified by their use of the terms and phrases such as "estimate," "project," "intend," "forecast," "anticipate," "plan," "planning, "expect," "believe," "will," "will likely," "should," "could," "would," "may" or the negative of such terms and other comparable terminology. All such forward-looking statements are based on current expectations and are subject to risks and uncertainties. Should any of these risks or uncertainties materialize, or should any of the Company's assumptions prove incorrect, actual results may differ materially from those included within these forward-looking statements. Accordingly, no undue reliance should be placed on these forward-looking statements, which speak only as of the date made. The Company expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. As a result of these factors, the events described in the forward-looking statements contained in this release may not occur.