Weekly Risperidone as Effective as Daily in Phase III Schizophrenia Study

An interim analysis of a Phase III trial suggests that a weekly form of risperidone might be sufficient for individuals with schizophrenia, based on findings from Lyndra Therapeutics announced on Thursday. The company's formulation, LYN-005, demonstrated efficacy comparable to the commonly used daily risperidone, marketed by Johnson & Johnson as Risperdal. The study reached its primary endpoint ahead of schedule due to these promising results.

During the trial, LYN-005 was given to adults diagnosed with schizophrenia and schizoaffective disorder. It delivered medication levels on par with J&J’s daily Risperdal, according to the mid-study results. Dr. Richard Scranton, Lyndra's Chief Medical Officer, emphasized that a weekly oral dose of risperidone could significantly improve treatment adherence and health outcomes for patients reliant on this medication.

Adherence to medication is a major challenge for those living with schizophrenia and schizoaffective disorder, impacting both patients and their caregivers. Approximately 60% of patients demonstrate low adherence to daily risperidone, according to research cited by Lyndra. Daily dosing can be burdensome, and difficulties in maintaining regular medication schedules are widespread.

The Phase III study also met secondary endpoints regarding safety and results on the Positive and Negative Syndrome Scale (PANSS). Lyndra asserts that its LYNX drug delivery platform offers advantages like consistent drug levels and reduced fluctuation between doses, beneficial for this patient group.

Looking ahead, Lyndra plans to initiate a six-month, double-blind pivotal safety study in the latter half of 2024, targeting patients with schizophrenia and schizoaffective disorders. Moreover, LYN-005 is under investigation for its potential efficacy in treating bipolar I disorder.

Separately, in January 2023, the FDA approved an extended-release form of risperidone for both schizophrenia and bipolar I disorder from Luye Pharma. Named Rykindo, this formulation is an intramuscular injection given biweekly.

Lyndra raised significant funding to support its endeavors, closing a $101 million Series E round in December 2023, following a $20.3 million Series D round earlier in June.

With these developments, Lyndra advances towards providing a longer-acting treatment option for those managing schizophrenia and other mental health conditions, potentially easing the burden of daily medication administration.