Better than Ambien? Minerva soars on PhIIb update on seltorexant for insomnia
A month after roiling investors with what skeptics dismissed as cherry picking of its depression data, Minerva is back with a clean slate of data from its Phase IIb insomnia trial.
In a detailed update, the Waltham, MA-based biotech said seltorexant (MIN-202) hit both the primary and several secondary endpoints, effectively improving sleep induction and prolonging sleep duration. Investigators made a point to note that the effects were consistent across the adult and elderly populations, with the latter more prone to the sleep disorder.
A total of 365 patients with no other psychiatric conditions were enrolled in the study and randomized into five groups: three different doses of seltorexant, placebo, and Ambien. Unlike the household drug, which promotes sleep by activating the GABA neurotransmitter, Minerva’s drug is “designed to mimic the natural sleep process by inhibiting the brain mechanisms that promote excessive wakefulness,” CEO Remy Luthringer said in a statement.
The drug scored a clear win in improving latency to persistent sleep (LPS) compared to placebo, as researchers tracked escalating least squares mean on changes from baseline on Night 1: 16.4 minutes (5 mg), 32.2 minutes (10 mg) and 36.6 minutes (20 mg), with p ≤0.001 on the two higher doses. “Advantages over placebo were also observed at Night 13: 5.2 minutes for the 5 mg, 28.6 minutes for the 10 mg (p ≤0.001), and 21.0 minutes for the 20 mg (p ≤0.001),” the company added.
But perhaps more interesting were the secondary analysis in which seltorexant seems to work better than Ambien in terms of LPS as well as WASO-6, a measurement of disturbed sleep throughout the night. That was true on Night 13 on both scores, notable because Ambien did not show superiority over placebo on the same night, likely due to a known, waning effect of the standard-of-care drug.
Minerva had much less to say about safety — a big deal on sleep drugs — other than that it’s well tolerated, with treatment-emergent adverse events (TEAEs) taking place in 33.8% of patients across the three drug arms compared to 49.3% in placebo group and 42.5% in the Ambien cohort. The FDA sets a high bar on safety for sleep drugs, creating a challenge that has kept most small players out of a difficult field. Marketing is also a big challenge, even for the major biopharmas.
The subsequent surge on share price $NERV — up 51.93% and reaching $6.43 — helped Minerva recover some lost grounds from the controversial readout in May. At one point pre-market trading brought the stock over $7 but the enthusiasm has subsided as investors ponder on the marketing challenges lying ahead.
That trial saw a decrease in the Montgomery-Asberg Depression Rating Scale among the 20 mg group, where patients were treated with the oral pill alongside standard antidepressant therapies.
Venturing into a field most biotechs have steered clear of, Minerva’s overall proposition with seltorexant is to treat insomnia and related mood disorders by tinkering with the orexin system, which is associated with feeding, homeostasis, arousal, modulation of sleep-wake cycles and motivation. J&J signed on as a partner to the ORX2 inhibitor on two indications in 2014, but returned the rights for insomnia three years later.
Patients with depression who also struggle to sleep — around 105 total between the drug and placebo arms — showed a bigger improvement in the MADRS than the overall trial population, the company had reported.
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