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Phase III Schizophrenia Trial Shows Lyndra’s Weekly Risperidone ‘Comparable’ to J&J’s Daily Risperdal

2024-07-23

研发

临床3期上市批准临床结果

The late-stage pharmacokinetic study was stopped early due to efficacy at interim analysis, Lyndra Therapeutics said Thursday. A six-month safety study will start in the second half of 2024.

Pictured: Man leaning against wall/iStock, KatarzynaBialasiewicz

Less pills taken by schizophrenia patients are potentially on the horizon, based on an interim analysis of a Phase III study. Lyndra Therapeutics reported Thursday that its weekly formulation of risperidone is as effective as Johnson and Johnson’s immediate-release, daily Risperdal.

The Phase III study was stopped early due to positive primary endpoint results from the mid-study analysis, the company said. Lyndra’s LYN-005 was administered to adults living with schizophrenia and schizoaffective disorder. The once-a-week oral formulation delivered “comparable medication levels” to J&J’s immediate-release Risperdal (IR risperidone), according to Thursday’s announcement.

“For people who rely on risperidone as part of their treatment regimen, oral weekly risperidone could vastly improve medication adherence and outcomes,” Lyndra’s CMO Richard Scranton said in a statement.

Adherence is a primary concern for patients living with schizophrenia and schizoaffective disorder, as well as their caregivers. Daily risperidone is one of the most prescribed treatments for schizophrenia. Research found around 60% of patients report low medication adherence with almost all reporting at least moderate struggle, according to Lyndra.

In addition to meeting its primary endpoint, the pivotal pharmacokinetic study also met secondary endpoints for safety and Positive and Negative Syndrome Scale (PANSS) score. The company believes its LYNX drug delivery platform benefits patients by delivering more consistent levels of medication, reducing the peak to trough variation of daily dosing.

Lyndra will launch a six-month, double-blind pivotal safety study in the second half of 2024 for patients with schizophrenia and schizoaffective disorders. LYN-005 is also being studied in bipolar I disorder.

Luye Pharma had a long-acting version of risperidone for both schizophrenia and bipolar I disorder approved by the FDA in January 2023. Rykindo is an intramuscular injection given once every two weeks. Lyndra closed a $101 million Series E raise in December 2023 after a $20.3 million Series D financing in June 2023.

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