Positive Results Announced From Phase 3 Trial of Oral Weekly Risperidone for Schizophrenia


The Starlyng-1 study showed that the treatment met its primary endpoint of a one-sided Cmin of >0.80; a one-sided Cmax of <1.25; and a two-sided Cavg of 0.80-1.40, with 90% confidence limits.

Positive results from a phase 3 trial comparing the pharmacokinetic profile of oral weekly risperidone (LYN-005) with immediate-release risperidone (Risperdal) for schizophrenia and schizoaffective disorder have been announced, Lyndra Therapeutics said in a release.1

Results from the Starlyng-1 (NCT05779241) study at the interim analysis showed that oral weekly risperidone (LYN-005) met the primary endpoint of a one-sided Cmin of >0.80; a one-sided Cmax of <1.25; and a two-sided Cavg of 0.80-1.40, with 90% confidence limits. The treatment also met the secondary endpoint for safety and Positive and Negative Syndrome Scale (PANSS) score, which is used to measure symptom severity in schizophrenia.

“These positive data demonstrate that a single dose of oral weekly risperidone delivers comparable medication levels to daily risperidone, validating that Lyndra’s LYNX drug delivery platform may provide a medication option that significantly reduces dosing frequency,” Richard Scranton, MD, chief medical officer and president of Global Product Development MPH at Lyndra Therapeutics, said in a release.1 “For people who rely on risperidone as part of their treatment regimen, oral weekly risperidone could vastly improve medication adherence and outcomes.”

The Starlyng-1 study assessed oral weekly risperidone 15 mg and 45 mg, which is equivalent to 2 mg and 6 mg daily Risperdal, in patients with schizophrenia and schizoaffective disorder who were on a stable dose of an oral antipsychotic medication. The study plans to enroll a total of 90 participants, with 46 at the interim analysis.

Lyndra said that the study is designed “to bridge the previously established safety and efficacy of immediate-release Risperdal for schizophrenia and bipolar disorder as agreed with the US Food and Drug Administration.” The biotechnology company has stopped the study early according to the pre-defined stopping criteria.

Risperidone is an atypical antipsychotic medication that was first approved by the FDA in 1993 to treat schizophrenia in adults and children ages 13 and older, bipolar I acute manic or mixed episodes in adults and children ages 10 and older, bipolar I acute manic or mixed episodes adjunctive with lithium or valproate in adults, and autism-associated irritability in children ages 5 and older.

STARLYNG-2, a pivotal safety study, is planned to begin in the second half of this year, according to Lyndra. The study will be a 6-month, double-blind study to characterize the safety profile of Lyndra’s LYNX drug delivery platform.

"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,” Jessica Ballinger, president and CEO of Lyndra Therapeutics, said in a release.1 “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.”

1. Lyndra Therapeutics Announces Positive Data from Pivotal Phase 3 Study with Oral Weekly Risperidone (LYN-005) for Schizophrenia. News Release. Lyndra Therapeutics. January 4, 2024. Accessed January 5, 2024. https://www.businesswire.com/news/home/20240104163052/en/Lyndra-Therapeutics-Announces-Positive-Data-from-Pivotal-Phase-3-Study-with-Oral-Weekly-Risperidone-LYN-005-for-Schizophrenia
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