The mid-stage failure was unexpected to analysts at BMO Capital Markets, who viewed ‘770 as mostly derisked given its similar mechanism of action to Johnson & Johnson’s Spravato.
Neurocrine Biosciences’ investigational pill NBI-1070770—or just ‘770—was unable to significantly improve depression severity in a mid-stage study, slowing the momentum the biotech has built in recent weeks.
In a brief announcement on Monday, Neurocrine announced that ‘770 “did not meet the primary endpoint” in its Phase II study, which had enrolled 73 patients with major depressive disorder who had shown inadequate response to at least one antidepressant therapy.
The study tested three doses of ‘770 for its effect on change in symptom severity from baseline, as measured by the Montgomery-Åsberg Depression Rating Scale.
Neurocrine did not provide specific data from the trial, with Chief Medical Officer Sanjay Keswani saying only that the biotech “will continue to analyze” the data “so we can determine appropriate next steps.” Keswani has not laid out a timeline for when Neurocrine expects to announce its plans for ‘770.
Writing to investors on Monday, analysts at BMO Capital Markets said the mid-stage fail “comes as a surprise,” given the asset’s mechanism of action. Neurocrine’s ’770 is a negative allosteric modulator of the NMDA receptor and acts via a “similar” pathway to Johnson & Johnson’s FDA-approved Spravato, BMO explained.
“While the mechanisms for these agents are not identical,” BMO continued, “going into Ph 2 updates for ‘770 many looked to Spravato as an agent that somewhat derisked the approach Neurocrine proceeded with.” Monday’s outcomes, however, “stand in contrast to [the] path laid forward by Spravato.”
“Results today continue to highlight the inherent risk in neuropsychiatric clinical development,” BMO continued, pointing to “higher rates of failure” in this field than in other therapeutic spaces.
Neurocrine’s business has built significant momentum in recent weeks. Late last month, the biotech announced $790 million in third-quarter total net product sales, representing a 28% year-on-year growth. Its main franchise, the tardive dyskinesia drug Ingrezza, likewise saw a 12% increase to bring in $687 million in the quarter.
Earlier this month, Neurocrine also unveiled an $881.5 million agreement with China’s TransThera Sciences, giving it worldwide rights to the biotech’s NLRP3 inhibitors for “multiple diseases,” likely involving metabolic or inflammatory conditions, though the partners have yet to disclose specific indications. TransThera will retain rights to its portfolio within the Greater China area.
