Q BioMed offers update on its autism drug QBM-001

Q BioMed Inc (OTCQB:QBIO) provided an update Tuesday on QBM-001, its autism spectrum disorder drug development program for non-verbal and minimally verbal autistic children.

The New York-based biotech is in the middle of preparing for the planned clinical trial of its drug candidate QBM-001, which is being tested to treat pediatric developmental nonverbal disorder in toddlers who suffer from autism spectrum disorders.

Working with its medical and scientific advisors, QBioMed is focusing on providing formulations of QBM001 that offer an improved safety profile in pre-clinical studies. The biotech’s management has also visited with many potential trial sites in the US and Europe over the last nine months in preparation for the planned clinical trial of QBM-001.

READ: Q BioMed takes the final step toward FDA approval of its bone pain relief injectable

“We are grateful for the feedback from clinicians, patients and their families and medical and scientific advisors,” said Denis Corin, Q BioMed’s CEO, in a statement. “All are excited about the roadmap for QBM-001 over the next six months and look forward to reporting on our progress.”

QBM-001 targets toddlers with pediatric developmental non-verbal disorders who report elevated blood markers that lead to developmental delay, an autism diagnosis and the eventual diminishment of their verbal capabilities.

Currently, there is no diagnostic tool available to identify children at risk of this condition at an early age. So, Q BioMed has vetted diagnostic options over the last nine 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 said in a release.

READ: Wall Street analyst kicks off Q BioMed coverage with ‘buy’ rating and punchy US$16 price target

QBioMed is in the process of completing and submitting the regulatory filings required for orphan drug designation for QBM-001 as well as an IND to initiate the planned clinical trial.

Ahead of the clinical trial, the biotech is also preparing partnerships with a Contract and Development Manufacturing organization to start manufacturing and Contract Research Organizations to finish pre-clinical studies, submit a pre-IND as well as an orphan drug designation filing. The company is also still securing its intellectual property through patent filings.

There are about 18,000 new cases of pediatric developmental nonverbal disorder in the US each year and a similar amount in Europe.

Not all toddlers who become nonverbal will benefit from QBM-001. But with validated biomarkers as well as testing from trained specialists and genetic testing, children who fall into this population can be identified and will have a better likelihood of responding to treatment.

QBioMed’s other drug candidates include Uttroside-B, a treatment for liver cancer, Strontium Chloride Sr89, a non-narcotic injectable designed to relieve bone pain in cancer patients, as well as MAN-01, which treats glaucoma.

The stock held steady Monday to finish at $2.97.

Contact Ellen Kelleher at [email protected].

Story by ProactiveInvestors