Q BioMed Provides Important Update on QBM001 Developmental Drug Targeting a Non-Verbal and Minimally Verbal Patient Subset on the Autism Spectrum
Published: Oct 09, 2018
NEW YORK, PRNewswire/ --
Q Biomed Inc.. (OTCQB: QBIO), a biotechnology acceleration company, is pleased to provide an update on QBM001, its Autistic Spectrum Disorder (ASD) drug development program for non-verbal or minimally verbal autistic children.
Q BioMed continues to develop its intellectual property including its patent pending QBM-001 drug technology, which is being tested for pediatric developmental nonverbal disorder in toddlers within the autism spectrum disorders. Working with its medical and scientific advisors, Q BioMed is focusing on QBM001 candidate formulations that seek to provide an improved safety profile in preclinical studies. Q BioMed has visited with many potential trial sites in the U.S. and Europe over the last 9 months in preparation for the planned clinical trial of its drug candidate.
Denis Corin, CEO of Q BioMed Inc. stated, "We are grateful for the feedback from clinicians, patients and their families and medical and scientific advisors. All are excited about the roadmap for QBM-001 over the next 6 months and look forward to reporting on our progress."
QBM-001 targets toddlers with pediatric developmental nonverbal disorder, where an underlying commonality of this subgroup is elevated blood markers that lead to developmental delay, an autism diagnosis and eventual nonverbal or very minimally verbal capability for the rest of their lives.
Although the nonverbal or very minimally verbal subgroup is definable by the lack of language development, there is no diagnostic tool to identify the children at risk at an early age. As such, Q BioMed has vetted diagnostic options over the last 9 months that could offer a way to diagnose these children as early as two years of age. These tools will be a part of the upcoming clinical trial in order to help validate them as potential biomarkers. Q BioMed is looking forward to announcing these partnerships in the coming months as we complete and submit the regulatory filings required for orphan drug designation and an IND to initiate the planned clinical trial.
In preparation for the clinical trial, Q BioMed is preparing partnerships with a Contract and Development Manufacturing Organization (CDMO) to start manufacturing, and Contract Research Organizations (CROs) to finish preclinical studies, submit a pre-IND, orphan drug designation filing and continue to secure its intellectual property through patent filings.
About Pediatric Development Nonverbal Disorder
There are approximately 18,000 new cases of pediatric developmental nonverbal disorder in the US each year and a similar amount in Europe. The majority of the children are diagnosed as young children and fall within the autism and epilepsy spectrum disorders. Individually, the economic costs for toddlers that become non- or minimally verbal is ten million dollars on average per person over their life. Collectively, an estimated 200 billion dollars is spent yearly on individuals who have become nonverbal in the US. Not all individuals who become 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 treatment.
About Q BioMed Inc.
Q BioMed Inc. "Q" is a biomedical acceleration and development company. We are focused on licensing and acquiring undervalued biomedical assets in the healthcare sector. Q 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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SOURCE Q BioMed Inc.
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