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Shares of NLS Pharmaceutics (NASDAQ: NLSP) are rallying premarket after the company announced that the US Food and Drug Administration (FDA) has accepted its Investigational New Drug application (IND) for Quilience.
Quilience is the company‘s lead drug candidate and is used to treat narcolepsy.
The open IND enables NLS to initiate its Phase 2a clinical trial to assess the safety and efficacy of Quilience in patients diagnosed with narcolepsy.
The multi-centre study will take place in the US and Europe and is expected to enrol 60 patients.
The primary endpoint of the trial, which is due to start in August, is the change from baseline in excessive daytime sleepiness as measured by the Epworth Sleepiness Scale, and a key secondary endpoint is a change from baseline in the mean weekly number of cataplexy attacks in the subset of patients with cataplexy.
“We are pleased to now have an open IND so that we can initiate our clinical program with Quilience®, our novel formulation of mazindol ER, for the treatment of narcolepsy,” said Alex Zwyer, CEO of NLS.
“We remain on track to commence our prospective Phase 2a clinical trial for Quilience next month as we focus on bringing this treatment option to patients suffering from narcolepsy as soon as possible.”
NLS Pharmaceutics' share price is trading at $3.65, up 21.26% premarket on Thursday.
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