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Neurotech International fails to get FDA orphan drug designation for cannabinoid drug therapy
A WA listed biotech has failed in its bid to get major backing from the US Food and Drug Administration for its cannabinoid drug therapy aimed at treating neurological disorders in children.
Nedlands-based Neurotech International is developing its lead drug candidate, NTI164, aimed at treating paediatric neurological disorders like autism, paediatric acute-onset neuropsychiatric syndrome (PANS) and paediatric autoimmune neuropsychiatric disorders associated with streptococcal infections (PANDAS).
The company on Friday revealed its request for a so-called orphan drug designation for the use of NTI164 to treat PANDAS/PANS had been declined because the regulator believes the disorders may not be classed as rare diseases in the US.
The FDA defines a rare disease as any condition that affects fewer than 200,000 patients in the US.
The orphan drug designation provides a company with a range of incentives, including market exclusivity, potential grant funding and a waiver on various administration fees.
“FDA feedback has provided Neurotech with valuable regulatory insights into PANDAS/PANS as a relatively new disorder where diagnosis and prevalence data are emerging,” Neurotech said in a statement.
“Neurotech, in consultation with its regulatory advisors, will consider providing a response to the FDA in the months ahead.”
The Thomas Duthy-led company is also seeking orphan drug designation for NTI164 for Rett syndrome, a rare genetic disorder affecting the way the brain develops.
It expects an outcome from the FDA before December.
“We have the potential to be the world’s first approved broad-spectrum cannabinoid drug therapy for autism spectrum disorder, Rett syndrome and PANS if we continue along our clinical pathway successfully,” Dr Duthy told The West Australian earlier this year.
“We’ve shown pre-clinically that when you add NTI164 to a group of cells in the brain . . . it is able to significantly dampen inflammatory processes.”
“Neuro inflammation . . . is a hallmark of autism, Rett, PANS and cerebral palsy.”
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