Q BioMed Inc., a biotechnology acceleration company, is in the beginning stages of developing QBM001, its Autistic Spectrum Disorder (ASD) drug program for nonverbal or minimally verbal autistic children.
The patent pending QBM-001 drug technology is being tested for pediatric developmental nonverbal disorder in toddlers within the autism spectrum disorders. Q BioMed says the company is focusing on QBM001 candidate formulations that seek to provide an improved safety profile in preclinical studies. In preparation for the clinical trials, Q BioMed has visited a number of potential trial sites in the U.S. and Europe over the last nine months.
QBM-001 targets toddlers with pediatric developmental nonverbal disorder. 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.
Because there is currently no diagnostic tool to identify risk of nonverbal or very minimally verbal subgroup of ASD at an early age, Q BioMed has been evaluating diagnostic options that could offer a way to diagnose children as early as two years of age. These tools are expected to be part of the upcoming clinical trial to help validate them as potential biomarkers.
Q BioMed indicated that it will announce these partnerships in the coming months as the regulatory filings required for orphan drug designation and an IND to initiate the planned clinical trial are submitted.
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.
According to Q BioMed, 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.
(Source: Q BioMed Inc.)