Nxera Pharma Ltd collects clinical US$35m milestone

Last week, Cambridge-based Neurocrine Biosciences Inc reported that the oral, muscarinic M4 selective agonist NBI-1117568 reached the primary endpoint in a Phase II dose-finding study. The drug candidate, together with three other internal programmes developed at the UK-based arm of Sosei Group, was licenced in 2021 in a US$2.6bn biobucks deal.

The demonstration of a clinically meaningful and statistically significant reduction from baseline in the Positive and Negative Syndrome Scale (PANSS) total score at Week 6 with a placebo-adjusted mean reduction of 7.5 and an 18.2-point reduction from baseline for the 20mg dose together with statistically significant improvement in the Clinical Global Impression of Severity (CGI-S) scale, Marder Factor Score – Positive Symptom Change, and Marder Factor Score – Negative Symptom Change triggered a US$35m milestone payment from Neurocrine Biosciences Inc. The company announced to advance NBI-1117568, which is suggested to have potential as Alzheimer’s drug,  into Phase III in early 2025.

NBI-1117568 is the most advanced from a broad portfolio of novel clinical and preclinical subtype-selective muscarinic M4 (NBI-1117568), M1 (NBI-1117567) and dual M1/M4 receptor (NBI-1117570)  discovered by Nxera and licenced for the treatment of neurological and neuropsychiatric disorders such as bipolar disorder, Parkinson’s, or Lewy Body Dementia. Under the terms of the 2021 agreement, Neurocrine is responsible for development costs associated with the programmes globally, except for M1 agonists being developed in Japan. Nxera retains rights to develop M1 agonists in Japan for any indication, subject to certain exceptions, with Neurocrine receiving co-development and profit share options.

Nxera has its headquarters and subsidiaries in Tokyo and Osaka (Japan), London and Cambridge (UK), Basel (Switzerland) and Seoul (South Korea) and is listed on the Tokyo Stock.