Two New York City biopharma companies, Q BioMed and Asdera, have signed a licensing deal built around a therapeutic intervention for autism spectrum disorder (ASD). Financial terms have not been released.
Announced Tuesday, the agreement gives Q BioMed exclusive worldwide rights to Asdera’s lead drug candidate ASD-002. The drug targets a symptom of ASD known as disruption of active language development (DALD). In other words, many children with the disorder lose the ability to speak.
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It’s an interesting take on a field with just two FDA-approved therapies; Risperdal and Abilify. Both are classified as antipsychotics and offer only temporary relief of aggression and irritability. While it’s very early days, ASD-002 seeks to alter the trajectory of the disorder.
Via email, Q BioMed CEO Denis Corin confirmed that no children have yet been treated as the companies first prepare for an investigational new drug (IND) filing with the FDA.
“We are working with leading pediatricians and regulators to be able to move this into a clinical trial by the end of this year,” Corin stated.
Started in June 2015, Q BioMed refers to itself as a biomedical accelerator focused on “licensing and acquiring undervalued and under-appreciated biomedical assets.” The OTCMKTS-listed company then works to support the development of those assets with additional resource and expert guidance.
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So what’s the value and potential of ASD-002?
The Centers for Disease Control and Prevention (CDC) estimates approximately 1 in 68 children in the United States will develop an autism spectrum disorder. Given it’s higher prevalence in males, those numbers include 1 in 42 boys and 1 in 189 girls.
Among the more than 60,000 U.S. children who develop ASD every year, around 20,000 become nonverbal or lose the ability to speak, according to a joint statement by the two companies. The ratio is similar in Europe.
Asdera – and evidently Q BioMed – believe they have found a genetic and biological basis for the impaired development of speech in toddlers with ASD. The companies point to research indicating that certain ion channels may not be active enough during those critical years.
ASD-002 is an ester prodrug of mefenamic acid, a decades-old non-steroidal anti-inflammatory drug (NSAID) that can activate those important ion channels. Some of that existing safety data and tolerability in adolescents may help fast-track the regulatory process, Corin said.
“There are similarities that should allow us to use some of the safety data about mefenamic acid,” he explained. “However, it is also unique enough for us to improve safety for this targeted group, while at the same time also providing efficacy through prophylactic administration for about a year’s time to hopefully ensure they have a better chance to develop speech and retain that capability for the rest of their life.”
Even if it does prove effective, a major challenge looms getting the drug to patients at an appropriate time.
According to a published review in the journal Autism, many children have signs of development delays between 0-18 months of life, but up to 40 percent of children with ASD initially demonstrate near-normal development until 18-24 months.
With EEG, behavioral, and genetic testing, Asdera and Q BioMed hope to identify and treat patients from 12 months of age. Corin said the field is making progress in that respect.
“In the US, the diagnosis criteria is becoming standard or mandated,” he stated. “In Europe, there is a growing trend towards the same in the UK, France and Germany thanks to the wonderful efforts of groups such as Autism Speaks, which has done an excellent job of educating government health organizations. We look to work with all patient organizations and pediatricians to spread the education about the importance of early diagnosis.”
Only time will tell whether ASD-002 can impact the development of speech in its target population. But for now, Q BioMed has another shot on goal and a mission to encourage early diagnoses and intervention.
Photo: MariaDubova, Getty Images
