Once-Weekly Oral Risperidone Comparable to Daily Risperdal for Schizophrenia

Oral risperidone (LYN-005) administered once a week shares a comparable pharmacokinetic profile with immediate-release oral Risperdal taken daily in adult patients living with schizophrenia. Initial positive data from the phase 3 STARLYNG-1 clinical trial (NCT05779241) were reported in early January by Lyndra Therapeutics.

“For people who rely on risperidone as part of their treatment regimen, oral weekly risperidone could vastly improve medication adherence and outcomes,” said Richard Scranton, MD, Lyndra Therapeutics’ chief medical officer and president of global product development.

STARLYNG-1, a multi-dose, open-label, parallel-group study, was designed to build upon the previously established safety and efficacy data behind immediate-release Risperdal for schizophrenia in agreement with the US Food and Drug Administration.

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The study examined the effect of oral weekly risperidone at 15 mg and 45 mg, equivalent to 2 mg and 6 mg daily Risperdal, respectively, in 46 participants with schizophrenia. At baseline, the study participants were on a stable dose of an oral antipsychotic medication.

At interim analysis, the trial had met its primary endpoint, the geometric mean ratio of the Week 5 oral weekly risperidone drug levels compared to the baseline immediate-release Risperdal drug levels. Within 90% confidence limits, LYN-005 exhibited a one-sided Cmin of greater than 0.80; a one-sided Cmax of less than 1.25; and a two-sided Cavg of 0.80-1.40.

STARLYNG-1 also met secondary endpoints for safety and Positive and Negative Syndrome Scale (PANSS) score. Due to the positive results at interim analysis, the study was stopped early, in accordance with pre-defined stopping criteria.

Lyndra will next conduct STARLYNG-2, a 6-month, double-blind study to elucidate the safety profile for the patented LYNX drug delivery platform, developed by Langer Laboratory.

“The LYNX drug delivery platform has the potential to transform how we take oral medicines, and we are very pleased with the positive interim data for our lead asset oral weekly risperidone,” said Jessica Ballinger, Lyndra Therapeutics’ president and CEO. “We are eager to bring long-acting oral therapies to patients and are focused on advancing oral weekly risperidone into its remaining pivotal safety trial in 2024.”

References

Lyndra Therapeutics announces positive data from pivotal phase 3 study with oral weekly risperidone (LYN-005) for schizophrenia. News release. Lyndra Therapeutics. Published online January 4, 2024. Accessed January 15, 2024.

Study to evaluate the pharmacokinetics (PK) and safety/tolerability of long-acting oral LYN-005. Clinicaltrials.gov identifier: NCT05779241. Updated April 18, 2023. Accessed January 15, 2024.