Neurotech International fails to get FDA orphan drug designation for cannabinoid drug therapy

[Pelican Press 0]

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Neurotech International fails to get FDA orphan ***** designation for cannabinoid ***** therapy

A WA listed biotech has ******* in its bid to get major backing from the US Food and ***** Administration for its cannabinoid ***** therapy aimed at treating neurological disorders in children.

Nedlands-based Neurotech International is developing its lead ***** 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 ***** 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 ********* in the US.

The FDA defines a rare ******** as any condition that affects fewer than 200,000 patients in the US.

The orphan ***** 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 ***** 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 ***** therapy for autism spectrum disorder, Rett syndrome and PANS if we continue along our clinical pathway successfully,” Dr Duthy told The West *********** 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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