Neurotech (ASX:NTI) has bounced back from a recent fast-track status rejection from the FDA, now launching a NTI164 baseline data study.
On October 4, Neurotech flagged to the market the U.S. regulator FDA had knocked back its application for orphan drug status – effectively a fast-track proviso.
Orphan drug status is awarded to compounds seeking to treat rare conditions where few if any treatments are already extant. Tax credits and reduced overall fees are benefits of winning the status, as well as marketing exclusivity rights.
But the FDA in October failed to consider as rare enough Paediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections (PANDAS) and Paediatric Acute- Onset Neuropsychiatric Syndrome (PANS) respectively – the two drugs NTI164 is intended to treat.
Data quality was part of the issue, and Neurotech had twelve months to respond.
On Monday, we’ve learned it’s now launching a pharmacokinetic (PK) study in healthy adult participants at CMAX Clinical Research in Adelaide to help shore up the company’s overall data offering.
“Although we have demonstrated long term safety and efficacy of NTI164 in paediatric patients across three separate neurological disorders, a PK study is a requirement for global health regulators, including the US Food and Drug Administration as part of an Investigational New Drug (IND) approval and the Australian Therapeutic Goods Administration,” Neurotech ED Dr. Thomas Duthy said.
The company noted this PK study shouldn’t necessarily get in the way of things long-term.
“As part of the necessary documentation to fulfill the requirements under an accelerated provisional application pathway [for the TGA], the study is expected to commence during the current quarter with results in Q1 CY2025,” Duthy added.
Overall, the study will look at metabolism of the drug, and, excretion data – in other words, how long it stays in the system for.
NTI last traded at 6.9cps.
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