Positive Results from Phase 3 Weekly Risperidone Study for Schizophrenia

A recent clinical study has shown promising results for a new drug delivery system that could revolutionize the way patients take medication. The research, conducted by Lyndra Therapeutics, a biopharmaceutical firm at the forefront of developing long-acting oral therapies, has demonstrated the efficacy of a weekly oral dosage of risperidone compared to the daily intake of Risperdal.

The study, known as STARLYNG-1, involved participants diagnosed with schizophrenia and schizoaffective disorder who were already on a stable dose of an oral antipsychotic. The primary objective was to compare the pharmacokinetic profile of the weekly oral risperidone (LYN-005) to that of daily immediate-release Risperdal. The study was designed to build upon the safety and efficacy data already established for Risperdal, in accordance with the U.S. Food and Drug Administration.

The pivotal trial included two dosages of oral weekly risperidone, 15 mg and 45 mg, which correspond to daily dosages of 2 mg and 6 mg of Risperdal, respectively. Initially, the study was planned to include 90 participants, with an interim analysis after enrolling 46.

During the interim analysis, the study successfully achieved its primary endpoint, which involved comparing the geometric mean ratio of drug levels of oral weekly risperidone in week five to the baseline levels of immediate-release Risperdal. The results showed that the weekly risperidone met the criteria for minimum and maximum concentration levels, with a confidence interval of 90%.

Given the positive outcomes, the study was halted early as per the predefined stopping guidelines. Richard Scranton, MD, MPH, Chief Medical Officer and President of Global Product Development at Lyndra Therapeutics, highlighted the significance of these findings. He stated that a single dose of oral weekly risperidone can deliver medication levels comparable to daily risperidone, suggesting that Lyndra's LYNX® drug delivery platform could offer a medication option that significantly reduces the frequency of dosing.

The study also confirmed that the weekly risperidone was well-tolerated and safe, meeting secondary endpoints for safety and symptom severity measurement using the Positive and Negative Syndrome Scale (PANSS). One of the key advantages of the LYNX platform is its ability to provide more consistent medication levels by reducing the variation between peak and trough levels compared to daily dosing.

Jessica Ballinger, President and CEO of Lyndra Therapeutics, expressed enthusiasm for the platform's potential to transform oral medication consumption. She emphasized the company's commitment to bringing long-acting oral therapies to patients and announced plans to advance oral weekly risperidone into its remaining pivotal safety trial in 2024.

The LYNX® Drug Delivery Platform, which originated from the Langer Laboratory, is enabled by over 50 patented innovations in design, engineering, and materials science. This platform offers a once-a-week dosing option, a significant advancement over traditional 'extended release' formulations that do not last more than a day.

Lyndra Therapeutics, a clinical-stage biopharmaceutical company, is focused on developing therapies for psychiatry, cardiometabolic diseases, and other conditions that could benefit from reduced dosing frequency. The company's lead product candidate, oral weekly risperidone (LYN-005), is intended for the treatment of individuals with schizophrenia and bipolar 1 disorder. Lyndra has received funding from various sources, including the Bill & Melinda Gates Foundation, the NIH, AbbVie, and Gilead Sciences, Inc.