Aevi Genomic Medicine to Present Updated Results from SAGA

New Post Public Reply Private Reply Replies (0) Message Board
News Desk 2018
141
Aevi Genomic Medicine to Present Updated Results from SAGA Trial of AEVI-001 at the 6th World Congress on ADHD

PHILADELPHIA, PA--(Marketwired - Apr 12, 2017) - Aevi Genomic Medicine, Inc. ( NASDAQ : GNMX ) (the Company) today announced that results identifying a genomic subset of responders from the SAGA trial of AEVI-001 will be presented at the 6 th World Congress on ADHD (Attention Deficit Hyperactivity Disorder) taking place April 20-23, 2017 in Vancouver, Canada. In addition, the Company will present findings from a non-interventional phenotype/genotype study of nearly 2,000 children diagnosed with ADHD.

The data will be presented by Garry A. Neil, M.D., Chief Scientific Officer and Liza A. Squires, M.D., Vice President, Head of Neuroscience, during two poster sessions. Details are as follows:

Title:   Double-blind placebo-controlled study of the novel therapeutic AEVI-001 in adolescents with ADHD and glutamatergic network gene mutations in children and adolescents with ADHD (SAGA Trial) Presenter: Garry A. Neil, M.D., Chief Scientific Officer, Aevi Genomic Medicine, Inc. Date:  Friday, April 21, 2017, 14:30-16:00 PDT Session:  Pharmacological treatment of children and adolescents II Abstract: P-17-001 Location: Exhibition Hall A, Vancouver Convention Centre

Title:   Glutamatergic network gene mutations in children and adolescents with ADHD (Phenotype/Genotype Study) Presenter: Liza A. Squires, M.D., Vice President, Head of Neuroscience, Aevi Genomic Medicine, Inc. Date: Friday, April 21, 2017, 14:30-16:00 PDT Session:  Aetiology II Abstract: P-02-006 Location: Exhibition Hall A, Vancouver Convention Centre

About AEVI-001

AEVI-001 is an oral non-stimulant pan selective activator/modulator of mGluRs. The molecule has excellent PK and metabolic profiles and crosses the blood brain barrier.

Aevi Genomic Medicine remains committed to the development of 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. The Company will also develop AEVI-001 for the treatment of autism spectrum disorder (ASD) patients with genomically identifiable mutations in the mGluR network. In the US, the CDC estimates that 6.4 million children 4-17 years of age (11%) have ever been diagnosed with ADHD. 1 Many ADHD patients remain unsatisfied with existing therapies, particularly with respect to safety, tolerability and treatment of comorbidities. In the US in 2012, 1 in 68 children were diagnosed with ASD (2012) increasing from 1 in 150 (2000) 2 . There is a high unmet need for pharmaceutical treatments for ASD as currently approved medications are indicated for symptoms of irritability in ASD patients.

AEVI-001 is an investigational agent that has not been approved by the US FDA or any other regulatory agencies.

About the SAGA Trial

SAGA was a multicenter, dose-optimized trial in adolescents with ADHD. The trial was designed as a randomized, double-blind, placebo-controlled, parallel-group study of AEVI-001 versus placebo in adolescent patients with ADHD who have genetic disorders impacting the mGluR network. The trial enrolled 101 patients (96 evaluable) between the ages of 12-17 years old. The primary and secondary endpoints in the trial were the change from baseline in the ADHD-Rating Scale Version 5 (ADHD-RS-5) Total Score and the percentage of subjects who responded as determined by the Clinical Global Impression of Improvement (CGI-I), respectively. Patients were 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. More information on the SAGA trial is available at www.ClinicalTrials.gov (Identifier: NCT02777931).

About Aevi Genomic Medicine, Inc.

Aevi Genomic Medicine, Inc. is dedicated to unlocking the potential of genomic medicine to translate genetic discoveries into novel therapies. Driven by a commitment to patients with pediatric onset life-altering diseases, the Company's research and development efforts leverage an internal genomics platform and an ongoing collaboration with the Center for Applied Genomics at The Children's Hospital of Philadelphia.

The Company is also progressing its second program, AEVI-002 into clinical development for Severe Pediatric Onset Crohn's Disease.

More information on the Company and pipeline is located on its website www.aevigenomics.com

Forward-looking Statements

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, its development and business strategy, its product candidates and the plans and objectives of management for future operations. 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.

Sources 1 https://www.cdc.gov/ncbddd/adhd/data.html 2 https://www.cdc.gov/ncbddd/autism/data.html

CONTACT: Aevi Genomic Medicine, Inc. Brian Piper Email Contact Westwicke Partners Chris Brinzey +1-339-970-2843 Email Contact MEDIA INQUIRIES: FTI Consulting Irma Gomez-Dib +1-212-850-5761 +1-415-706-9155 http://irma.gomez-dib@fticonsulting.com

Scroll down for more posts ▼

Top 10 Most Recent News Articles

Li-Fire Expands Fire Safety Amid Rising Battery Risks

Updated Category News Views 4

A Crunchy Look at New Fire Safety Moves Well, folks, here's a twist we didn't see coming but sure makes sense in today's electrifying business landscape. Li-Fire, the big brains behind lithium battery fire suppression, is spreading its wings nationwide, or at least its wholesale and distribution programs are. And right ahead of National Fire Safety Week no less—talk...

Continue Reading
Managed Connectivity: Key to Modern Multifamily Living

Updated Category News Views 2

Connectivity Runs the Modern Show Imagine moving into a shiny new apartment, where the biggest hassle isn't unpacking boxes but ensuring your gadgets get online smoothly. That's the reality of today's multifamily living, where the internet is more than a utility—it's the backbone of modern life. And if you think it's just about offering internet access, you're missing...

Continue Reading
FSS Unveils AI Tool to Simplify Bankruptcy Cases

Updated Category News Views 5

AI Revolution in Bankruptcy Management Alright, folks, there's a fresh breeze blowing in the bankruptcy management world, and it bears the acronym FSS. Financial Software Solutions is rolling out its innovative FSS Intelligence Engine. This little powerhouse aims to turn what used to be a gut-wrenching slog through mountains of paperwork into a slick, automated process....

Continue Reading
Ultrabench Revolutionizes AI Model Comparison Game

Updated Category News Views 2

Breaking Down the Messy AI Model Landscape Ultrabench.ai is here to drag AI model comparison out of the dark ages. Picture this: 309 AI models, ranked against a whopping 530 benchmarks, all served up on one plate. If you’re navigating the AI jungle, you’ll realize how Ultrabench is no small fish in this vast ocean. Consolidating Where Others Have Scattered There's a...

Continue Reading
Superga and Pasqua's Unlikely Fashion-Vineyard Fusion

Updated Category News Views 10

Superga and Pasqua: A Fusion of Fashion and Vineyards Here's one for the books: Superga, the storied Italian footwear maestro, teaming up with Pasqua Wines, straight out of Verona’s vineyard heartland. On the surface, it seems a rather odd coupling. One's got rubber soles; the other’s got corks. But they’ve pulled off a daring bedroom switch, creating a...

Continue Reading
Texas A&M-San Antonio's Research Expansion Momentum

Updated Category News Views 1

Texas A&M-San Antonio's Rising Research Ambitions A rainy day in San Antonio and Texas A&M University-San Antonio seems to have set the stage for more than just another semester of record enrollment. They’ve just rolled in with an exhilarating $8 million in external grants this fiscal year, more than doubling last year’s haul of $3.6 million, in a bid to push their...

Continue Reading
Gateway Unveils All-In-One Award Travel Platform

Updated Category News Views 3

Transforming Loyalty with point.me's Gateway Here's the deal: the loyalty program game just changed. Point.me rolled out this slick beast called Gateway, and it's weaving award travel booking right into your everyday banking apps. That's right, ditch those clunky third-party sites, because now you can browse, compare, transfer, and book your award travel directly from...

Continue Reading
EPR Fireworks, Schedule2.IT Enhance EMS Integration

Updated Category News Views 6

Joining Forces for Effective EMS Management In a move that could shake up emergency medical services, EPR Fireworks has teamed up with Schedule2.IT to amp up integration. This Florida-based partnership is all about breaking down those bureaucratic firewalls between patient care and controlled substances tracking. They’re pushing for a seamless workflow, where crucial...

Continue Reading
Nelson-Jameson Boosts Cold Storage in California Move

Updated Category News Views 1

An Icy Boost for the West Coast Dairy Player Every now and then, a company gets its cold storage game just right. Nelson-Jameson has added fresh muscle to its Turlock facility in California, making waves with serious logistical upgrades. The company's dogged pursuit of better operational efficiency in dairy processing isn't just about bragging rights. It's plain old good...

Continue Reading
JennAir and Cosentino Introduce Seamless Kitchen Aesthetics

Updated Category News Views 8

It's not every day that the kitchen landscape gets a bold makeover, but JennAir and Cosentino seem to think it's time. Introducing their latest splash, the JennAir x Dekton panel collection is here to redefine what luxury kitchens can look like—an embodiment of seamless beauty that’s more sculpture than cooking space. Elevating Kitchen Design So, what's the buzz about...

Continue Reading

Top 5 Most Recently Viewed Articles

Understanding Monthly Distributions of Picton Mahoney Funds

Updated Category News Views 169

Monthly Distribution Announcement from Picton Mahoney Today marks an important moment for investors as Picton Mahoney Asset Management has declared its monthly cash distributions for several of its Exchange Traded Funds (ETFs). These distributions showcase the firm’s ongoing commitment to providing value to its unitholders. Understanding these distributions can help...

Continue Reading
Unlocking Dexterity: Sanctuary AI's Breakthrough in Robotics

Updated Category News Views 335

Revolutionizing Robotic Dexterity with Sanctuary AI Sanctuary AI is pushing the boundaries of robotics by developing advanced technologies that mimic human-like intelligence and dexterity in robots. With a keen focus on enhancing general-purpose robot capabilities, Sanctuary AI has reached a significant milestone by introducing robotic hands that boast 21 degrees of...

Continue Reading
Ratio Therapeutics and Macrocyclics Form a Strategic Alliance

Updated Category News Views 241

Ratio Therapeutics Partners with Macrocyclics Ratio Therapeutics Inc. has made a significant move in the world of pharmaceuticals by partnering with Macrocyclics Inc. This partnership is set to revolutionize access to Ratio's innovative chelator, Macropa™, designed for radiopharmaceutical applications. Through this agreement, Macrocyclics will have exclusive...

Continue Reading
Discover How LAD Enhances Security with Innovative Technologies

Updated Category News Views 161

Revolutionizing Network Security with LAD Technology In today's digital age, security is a paramount concern for both individuals and organizations. IPCopper, Inc. is meeting this challenge head-on with its innovative LAD platform, which seamlessly combines essential security functions into a singular, downloadable appliance. With the ever-growing reliance on TLS...

Continue Reading
Utz Brands Reports Q4 Earnings: Performance Insights Revealed

Updated Category News Views 149

Utz Brands Q4 Earnings Overview The earnings results for Utz Brands (NYSE: UTZ) for the fourth quarter have been released, providing important insights into the company's performance. This announcement marks a significant moment for investors and stakeholders who are keen on the snack food industry. Quarterly Earnings Analysis Utz Brands reported that it missed the...

Continue Reading