Neurocrine, Takeda Look to Build on Positives Post Luvadaxistat’s Schizophrenia Trial Failure

San Diego-based Neurocrine Biosciences announced top line data from their Phase II INTERACT study, which looked at evaluating luvadaxistat to treat negative symptoms and cognitive impairment linked with schizophrenia.

The drug, which was licensed from Takeda in June 2020, failed to meet its primary endpoint as measured by the alteration from baseline on the PANSS NSFS on day 84 but somehow managed to meet the secondary endpoints of cognitive assessment. This led to Takeda’s shares rising by approximately 2%, while Neurocrine dropped by 8%.

Schizophrenia, which affects approximately 20 million people globally, is a chronic disorder that results from complex crosstalk between genetic and environmental factors. Luvadaxistat is an oral, selective inhibitor with a high binding affinity to d-amino acid oxidase while targeting glutamate, a copious neurotransmitter in the human brain. The company has not been bogged down by failure from their drug and intends to investigate the successful secondary endpoints.

“The Phase II INTERACT study was a well-designed and executed clinical study that resulted in a negative outcome for luvadaxistat on the primary endpoint assessing the change from baseline in negative symptoms of schizophrenia. We are, however, encouraged that secondary endpoints assessing cognitive performance within the trial were met and that treatment-emergent adverse events reported were consistent with previous luvadaxistat studies,” said Eiry W. Roberts, M.D., Chief Medical Officer of Neurocrine Biosciences.

Neurocrine is keen to take the positives and move forward in a different direction. “The totality of the top-line data from this study, therefore, support further clinical evaluation of luvadaxistat. We plan to work with our partner Takeda as we move forward.” Roberts added.

INTERACT Trial

The INTERACT study comprising of 256 adults was a 12 week, randomized, multi-center, double-blind, placebo-controlled which was conducted to understand the efficacy, safety, tolerability, and pharmacokinetics of three dosing levels of luvadaxistat in adult patients with negative symptoms of schizophrenia.

The study which failed to meet the primary endpoint was not only well-designed but followed the route of other unsuccessful drugs with the same target mechanism of action, which was increasing D-serine through DAAO inhibition.

Global Positioning

Although the results from the INTERACT study are disappointing, it should not come across as a surprise since this field has a host of other failed drugs which tried to prove their mettle in the market. Further research and better drugs are mandated to improve the quality of life in patients.

Not letting this hiccup disrupt their pipeline, Neurocrine intends to launch a number of clinical trials with their most promising candidates in epilepsy. During the pandemic, the company capitalized on their Parkinson’s Disease drugs, Ingrezza, whose final sales for the year 2020 increased by approximately 34% over 2019, and Ongentys’ racked up $1 million in sales during the fourth quarter. This is extremely promising as the company looks to strategically position itself in the healthcare domain and capture market share.

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Tulip Chakraborty