- Marks the first time a company has identified biomarkers that hold the potential to stratify this subset of patients
- Study examined 1,953 significant autistic biomarkers, resulting in 2 significant markers tied to expressed genes and pathways responsible for speech development
- Biomarkers in the nonverbal subset were distinct from children with typical speech development with or without autism
- Biomarkers will help homogenize clinical trial participants and will be studied as possible diagnostic and prognostic indicators during trials
New York, New York--(Newsfile Corp. - April 10, 2019) - Q BioMed Inc. (OTCQB: QBIO), a commercial stage biotech company, announced today the discovery of two novel biomarkers for pediatric nonverbal autism, identified in a subset of children with Autism Spectrum Disorder (ASD). This marks the first time a company has been able to identify biomarkers that hold the potential to stratify this subset of children. The study took into consideration 1,953 potential biomarkers and used Vineland II scores to stratify 240 children into three groups: verbal, semi-verbal, and nonverbal autism.
Q BioMed CEO, Denis Corin highlighted, "This is a major breakthrough for these children and their families. To date, very little attention and research has been focused on these nonverbal autistic children. In partnership with the clinical and advocacy community, Q BioMed is leading the effort to better stratify this group, while also pursuing a treatment."
Children of this subset typically never develop the ability to speak, or commence with language progression between 9-14 months and then regress. Most psychologists and physicians feel comfortable providing a diagnosis of nonverbal around the age of 7 years. Each year, an estimated 18,000-20,000 newborns will go on to become autistic and nonverbal in the U.S.
Speaking to the benefit of the biomarker work completed to date by Q BioMed, Corin explained, "Children with ASD need safe, effective and targeted treatments that are tested under conditions that take their best interests into consideration. Today's announcement ensures we continue to take a tailored and patient-centric approach to find those children who will benefit the most from our efforts."
One of the highlights of the biomarker study was the identification of known genes and pathways that are directly implicated in speech impairment. The studies also revealed comorbidities that manifest serologically as early as 18 months (the lower limit of detection to date) even though the children do not yet manifest clinical symptoms of these diseases.
To date, the results would allow for the development of diagnostic capabilities for children as young as 18 months and as old as 6 years. Further studies are needed for children older than 6 years.
Q BioMed will continue to enrich its data set for these biomarkers over time and work with its advisory committee, regulators and partners to incorporate these biomarkers into the QBM-001 trial design. In parallel, Q BioMed is finishing the formulation of QBM-001. The completion of formulation over the next couple months will then lead to subsequent regulatory filings and ongoing IND enabling studies.
QBM-001 targets toddlers with pediatric nonverbal autism, where underlying commonalities - as further reinforced by this current biomarker study - lead to developmental delay, an autism diagnosis, and eventual nonverbal or very minimally verbal capability for the rest of their lives.
About Pediatric Nonverbal Autism
There are approximately 18,000-20,000 new cases of pediatric nonverbal autism in the U.S. each year and a similar amount in Europe. The majority of the children are diagnosed by the age of seven and fall within the autism spectrum. Individually, the economic costs for toddlers that become non- or minimally verbal is $10 million dollars on average per child over a lifetime. Collectively, an estimated $200 billion is spent yearly on individuals who are nonverbal in the U.S. Not all individuals who are nonverbal will benefit from QBM-001. However, with validated biomarkers, testing from trained specialists and genetic testing, children who fall in this targeted population can be identified, and will have a higher likelihood of responding to an approved treatment.
About Q BioMed Inc.
Q BioMed Inc. is a biotech acceleration and commercial stage company. We are focused on licensing and acquiring undervalued biomedical assets in the healthcare sector. Q BioMed is dedicated to providing these target assets; strategic resources, developmental support, and expansion capital to ensure they meet their developmental potential, enabling them to provide products to patients in need.
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