WATERTOWN, Mass.– Lyndra Therapeutics, a clinical-stage biopharmaceutical company working to make daily pills a thing of the past, today announced it will present a poster on the results of a simulation-based predictive modeling study comparing the Positive and Negative Syndrome Scale (PANSS) scores produced by oral weekly risperidone (LYN-005) and oral daily risperidone at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, being held from May 30 to June 2, 2023, in Miami, Florida. The research will be presented at 12:30 p.m. EDT on June 1 by Lyndra’s Senior Director, Preclinical and Clinical Pharmacology, Jim Jiang, Ph.D.
For this study, researchers sought to compare the medication levels and symptoms expected in people taking oral weekly risperidone versus those taking daily (IR) risperidone. Researchers used simulation-based predictive modeling to explore if average and minimum medication concentrations in the blood were likely to have an impact on symptoms as measured by PANSS, a medical scale of symptom severity in schizophrenia. The models showed that, compared to daily risperidone, oral-weekly risperidone is expected to provide similar exposure to the medication, but with higher trough and lower peak (i.e., more consistent) medication concentrations in the blood. These more consistent medication levels are predicted to reduce fluctuation in total PANSS scores. Additionally:
- The simulated minimum steady-state blood plasma concentration of risperidone for people taking oral weekly risperidone (LYN-005) doses of 15, 30, and 45 mg maintained effective concentrations.
- No apparent trend was observed between simulated average steady-state blood plasma concentrations with oral weekly risperidone and symptoms as measured by PANSS score.
- A higher simulated minimum steady-state blood plasma concentration of risperidone with oral weekly risperidone was associated with a slight decrease in PANSS score (meaning a slight reduction in how much symptoms impacted a person’s life).
Lyndra’s long-acting oral weekly risperidone is designed to enable a week-long dose of risperidone to be delivered in a single oral capsule. Lyndra’s LYNX™ drug delivery platform makes oral weekly risperidone possible. Oral weekly risperidone (LYN-005) is currently being studied in pivotal trials.
“The data provided by these predictive models show the promise of oral weekly risperidone to deliver more consistent medication levels than daily (IR) risperidone,” said Lyndra’s Chief Medical Officer, Richard Scranton, M.D., M.P.H., one of the study’s authors. “Compared to IR risperidone, the predicted consistent therapeutic drug levels and reduced PANSS score for long-acting oral weekly risperidone offer the possibility of improved symptom control and the potential for lower doses that could result in fewer side effects for patients.”
The dramatically reduced dosing frequency of a weekly vs daily pill has the potential to increase medication adherence, which may in turn help reduce the risk of relapse and improve outcomes for people living with schizophrenia.
Currently, the only long-acting medicines available for schizophrenia require injections, and data show that they are used by a minority of patients.
