Lyndra Therapeutics has announced positive results from the Phase III STARLYNG-1 (LYN-005-C-301) clinical trial of oral weekly doses of risperidone (LYN-005) to treat schizophrenia and schizoaffective disorder in adults.
The trial was designed to enrol nearly 90 subjects to assess the pharmacokinetic (PK) profile of 15mg and 45mg oral weekly doses of risperidone versus 2mg or 6mg immediate-release Risperdal given daily.
It included patients on a stable oral antipsychotic treatment at the trial commencement.
STARLYNG-1 is intended to bridge the previously reported safety and efficacy data of Risperdal for treating schizophrenia and bipolar disorder as permitted by the US Food and Drug Administration.
The study met the primary endpoint at the interim assessment stage. The geometric mean ratio of week five oral weekly risperidone drug levels against baseline Risperdal drug levels was the endpoint.
Furthermore, orally administered weekly doses of risperidone achieved the endpoint of a one-sided Cmin of >0.80, a one-sided Cmax of <1.25, as well as a two-sided Cavg of 0.80-1.40, with 90% confidence levels.
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These findings led to the trial stopping ahead of schedule.
The trial also met the safety and the Positive and Negative Syndrome Scale (PANSS) score, its secondary endpoints.
Risperidone’s safety and tolerability profile was found to be well-received.
With the conclusion of STARLYNG-1, the company intends to commence a safety study dubbed STARLYNG-2.
It will assess the safety profile of the LYNXdrug delivery platform in the second half of this year for schizophrenia and schizoaffective disorders.
Lyndra Therapeutics global product development president and chief medical officer Richard Scranton said: “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.
“For people who rely on risperidone as part of their treatment regimen, oral weekly risperidone could vastly improve medication adherence and outcomes.”