Neurizon Therapeutics (ASX:NUZ) will begin "in the coming weeks" the two pharmacokinetic studies that are necessary to lift the clinical suspension on its investigational new drug application for NUZ-001, according to a Monday filing with the Australian bourse.
The US Food and Drug Administration placed the application for NUZ-001 under clinical hold last January amid concerns about the adequacy of relevant information, raising potential risks to human subjects.
Neurizon said the two upcoming pharmacokinetic studies will provide additional animal exposure data specifically requested by the US FDA to assess the adequacy of systemic exposure to NUZ-001. A formal response from the regulator is expected within the next 60 days, the filing stated.
Neurizon expects the studies to cost between AU$400,000 and AU$600,000, which is eligible for a government R&D rebate, per the filing.
The biotechnology company is developing NUZ-001 for the treatment of amyotrophic lateral sclerosis or ALS, which is the most common form of motor neuron disease.
Neurizon's shares fell 5% in recent trade.
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