Q BioMed has successfully developed a new and proprietary analog of QBM-001 in partnership with Sphaera Pharma for its intended use in pediatric developmental nonverbal disorder.
The novel analog was selected from an array of candidates that Sphaera Pharma's patented platform produced and QBM-001's pharmacodynamics demonstrated the best improvement in safety without compromising efficacy.
"We are very pleased to have successfully reached our developmental milestone with great results thus far, putting us in position to help these young children as well as their parents and caregivers," said Denis Corin, CEO of Q BioMed. "We are highly motivated to develop a drug and delivery system that will accommodate their very specific needs. As a result of meeting this milestone, we are now in a position to move QBM-001 into the clinic as quickly as possible."
The complete panel of preclinical testing is scheduled to finish in January of 2018. In parallel, Q BioMed is pursuing cGMP manufacturing and regulatory filings in preparation for the IND.
The proprietary analog will also provide Q BioMed with a global composition of matter patent for QBM-001. This will ensure that QBioMed can pursue the abbreviated 505(b)2 regulatory pathway in the USA to hopefully provide toddlers benefit from QBM-001 as soon as possible.
There are approximately 20,000 new cases of pediatric developmental nonverbal disorder in the USA each year and a similar amount in Europe. The majority of the children are diagnosed as toddlers and fall within the autism and epilepsy spectrum disorders. Individually, the economic costs for toddlers that become non- or minimally verbal is ten million on average per person over their life. Collectively, an estimated 200 billion dollars is spent yearly on individuals who have become nonverbal in the USA. Not all individuals who become nonverbal will benefit from QBM-001, but testing from a trained specialists and blood tests, coupled with genetic testing can identify a targeted population that will have a higher likelihood of responding to treatment.