Nxera notes Phase 2 data for partnered schizophrenia candidate NBI-1117568

Nxera Pharma (SOLTF) notes the announcement by its partner Neurocrine Biosciences Inc. (NBIX) that NBI-1117568 has delivered positive topline results from its Phase 2 clinical study in adults with schizophrenia. NBI-‘568 is the first investigational, oral, muscarinic M4 selective agonist in development for the treatment of schizophrenia. NBI-‘568 is the most advanced candidate from a broad portfolio of novel clinical and preclinical subtype-selective muscarinic M4, M1 and dual M1/M4 receptor agonists discovered by Nxera and advancing under a 2021 global collaboration with Neurocrine for the treatment of major neurological disorders. To date, Nxera has received multiple, significant payments from Neurocrine including those based on developmental progress of four candidates in clinical trials and is eligible to receive development, regulatory and commercial milestones of up to US$2.6 billion, plus product royalties, provided the criteria under the agreement are satisfied. Nxera retains rights to develop M1 agonists advancing under this collaboration in Japan in all indications, subject to certain exceptions. The NBI-‘568-SCZ2028 dose-finding study met its primary endpoint for the once-daily 20 mg dose. It demonstrated a clinically meaningful and statistically significant reduction from baseline in the Positive and Negative Syndrome Scale total score at Week 6 with a placebo-adjusted mean reduction of 7.5 points and an 18.2-point reduction from baseline. The once-daily 20 mg dose also demonstrated a statistically significant improvement for additional endpoints, including improvement in the Clinical Global Impression of Severity scale, Marder Factor Score – Positive Symptom Change, and Marder Factor Score – Negative Symptom Change. NBI-‘568 was generally safe and well-tolerated at all doses studied in the Phase 2 clinical trial. Treatment discontinuation rates due to adverse events were similar between NBI-‘568 and placebo. Adverse events with the highest incidence were somnolence, dizziness, and headache. Gastrointestinal adverse events including nausea and constipation were low in frequency and similar to placebo. Cardiovascular-related events were also low in frequency and were not deemed to have clinical relevance at any dose tested. NBI-‘568 was not associated with a greater increase in weight than placebo. Few extrapyramidal symptoms adverse events were reported.