Pharmaceutical

Aevi Genomic Medicine (NASDAQ: GNMX) announced their financial results for 2016 and provide a business update.

Aevi Genomic Medicine (NASDAQ: GNMX) announced their financial results for 2016 and provide a business update.
As quoted in the press release:

“2016 was an important and productive year for the Company,” said Mike Cola, CEO of Aevi Genomic Medicine. “We made significant progress, advancing both our genomic medicine strategy and our lead program, AEVI-001 in the Phase 2/3 SAGA trial in adolescents with mGluR+ ADHD. We remain on track to share top-line results from the trial later this month, and to begin two signal finding studies of AEVI-001 in the coming months, the first in Autism Spectrum Disorders (ASD) and the second in Pediatric Generalized Anxiety Disorder (PGAD).
During the second half of the year, we anticipate announcing data from our ongoing Phase 1/2 signal finding study of the Anti-LIGHT antibody in Severe Pediatric Onset Crohn’s Disease. This will be a transformative year for Aevi, as we continue to progress our pipeline, further demonstrating our ability to truly unlock the potential of genomic medicine in our efforts to deliver targeted therapies to patients with pediatric onset, life-altering diseases.”
Recent Highlights and Upcoming Anticipated Milestones
AEVI-001

  • Top-line data results from the Phase 2/3 SAGA trial of AEVI-001 in mGluR+ ADHD to be reported in 1Q17. In January 2017, the Company announced completion of enrollment in its Phase 2/3 study of adolescents with mGluR+ ADHD trial (SAGA). The trial is designed as a randomized, double-blind, placebo-controlled, parallel-group Phase 2/3 study of AEVI-001 versus placebo in adolescent patients with ADHD who have genetic disorders impacting the mGluR network. The trial enrolled patients between the ages of 12-to-17 years old. The primary and secondary endpoints in the trial are the change from baseline in the ADHD-rating scale Version 5 (ADHD-RS-5) Total Score and the percentage of subjects who respond as determined by the Clinical Global Impression of Improvement (CGI-I). Patients have been randomized 1:1 to receive either a six-week course of AEVI-001 or placebo, with a one-week follow-up. Patients were enrolled from sites that participated in the recent phenotype/genotype study. The study remains on track with top-line data expected later this quarter.
  • Prevalence of mGluR mutations in ADHD population confirmed by large-scale phenotype/genotype study. The Company is conducting a multi-center phenotype/genotype study of greater than 1,800 patients, confirming the prevalence of mGluR mutations in pediatric and adolescent ADHD populations at approximately 25%. Additional phenotypic data (presented at the 63rd Annual American Academy of Child and Adolescent Psychiatry Meetings (AACAP) in Oct 2016) showed a significantly higher prevalence of symptoms associated with emotional dysregulation in mGluR+ patients. Symptoms of emotional dysregulation, including anger control and disruptive behavior, have been shown to have significant life consequences for those affected.
  • Signal finding studies in Autism Spectrum Disorder (ASD) and Pediatric Generalized Anxiety Disorder (PGAD) to begin. The Company is intending to conduct signal finding studies in Autism Spectrum Disorders (ASD) and Pediatric Generalized Anxiety Disorder (PGAD) and expects to have initial open-label responder data from both studies in 2H17.

AEVI-002 (Anti-LIGHT mAb)

  • Data from Phase 1/2 signal finding study in severe pediatric onset Crohn’s disease expected in 2H17. The Company completed the collaboration with Kyowa Hakko Kirin 2H 2016 and initiated a Phase 1/2 signal finding study in up to 12 patients with severe pediatric onset Crohn’s disease in collaboration with The Children’s Hospital of Philadelphia (CHOP).

The Children’s Hospital of Philadelphia (CHOP)

  • Expanded Collaboration with CHOP. On February 21, 2017, the Company announced the extension of its existing collaboration with CHOP, which grants the Company options for long-term exclusive access to certain data and samples from the CAG biobank and certain discoveries in rare and orphan diseases. The Company will utilize these data to inform the rational search and acquisition process used to identify development candidates for advancement into therapeutic and diagnostic products for sick children. As part of the agreement, the Company also renewed its Sponsored Research Agreement (SRA) for a third time with CHOP since the collaboration was originally established in 2014.

Investor Day

  • Highlighted AEVI-001 and Market Opportunities in ADHD. On February 22, 2017, the Company hosted an investor day for analysts featuring presentations by management and key opinion leaders to discuss the research and development efforts supporting AEVI-001, as well as its commercial potential in the ADHD market. The event included presentations by Hakon Hakonarson, M.D., Professor of Pediatrics at the University of Pennsylvania School of Medicine and Director of the Center for Applied Genomics (CAG), The Children’s Hospital of Philadelphia (CHOP) and Jonathan E. Posner, M.D., Associate Professor of Psychiatry at Columbia University Medical Center. A webcast of the event can be found under the Events section of the Company’s website at http://phx.corporate-ir.net/phoenix.zhtml?c=217925&p=irol-irhome.

Organizational Update

  • During 4Q16, the Company completed a corporate re-branding and began trading on the NASDAQ Global Market under the ticker symbol (GNMX), thus completing the Company’s shift in strategy and business model that began implementation in early 2016.

Click here to read the full press release.

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