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Minerva Spikes Higher After Novel Insomnia Drug Aces Mid-Stage Trial

Shanthi Rexaline

Shares of thinly traded micro-cap biotech Minerva Neurosciences Inc (NASDAQ: NERV) spiked higher on Monday.

What Happened

Minerva announced results of a Phase 2b study that evaluated its seltorexant, codenamed MIN-202, in patients with insomnia disorder that met the primary endpoint of demonstrating a highly statistically significant and clinically meaningful improvement on Latency to Persistent Sleep, or LPS, at night 1.

There was a mean decrease from baseline of 15 minutes in LPS for the placebo compared to 30 minutes for seltorexant 5mg and 50 minutes for seltorexant 10mg and 48 minutes for seltorexant 20mg.

Seltorexant is a specific orexin-2 receptor antagonists for the treatment of insomnia.

The key secondary point as defined as Wake After Sleep Onset over first 6 hours at Night 1 showed improvement after treating with 10mg and 20mg of the pipeline asset.

Minerva noted that multiple secondary endpoints also showed improvement compared to placebo as well as the current standard-of-care Ambien.

Seltorexant showed a good safety and tolerability profile in both adult and elderly patients, it added.

Why It's Important

Minerva is developing seltorexant with Johnson & Johnson (NYSE: JNJ)'s Janssen unit, with the former having exclusive commercialization rights to it.

Seltorexant is also being evaluated for major depressive disorder.

"Unlike existing therapies, seltorexant is designed to mimic the natural sleep process by inhibiting the brain mechanisms that promote excessive wakefulness rather than by sedating patients through the activation of the neurotransmitters that promote sleep," said Remy Luthringer, CEO of Minerva.

Minerva shares traded higher by 51% to $6.38 at time of publication.

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