WATERTOWN, Mass.--(BUSINESS WIRE)--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.
The pivotal clinical trial of LYN-005, announced in May 2023, is ongoing.
About Schizophrenia/Schizoaffective disorder
Schizophrenia and schizoaffective disorder are serious, long-term mental health conditions that may make it difficult for people to think clearly, manage emotions and function in daily activities. Schizophrenia affects approximately 24 million people or 1 in 300 people (~0.32%) worldwide.1 Schizophrenia typically manifests as hallucinations, delusions and disorganized thoughts and behavior. Medication non-adherence, estimated to be around 50%,2 is the most common risk factor for relapse in patients with schizophrenia. Studies have shown that simpler, less frequent dosing can improve adherence and outcomes among those who are unable to comply with daily medication regimens. Today, the only long-acting formulations available are injectables, however, many patients prefer oral medications. Oral weekly risperidone (LYN-005), if approved, may provide a long-acting oral alternative that patients and caregivers prefer.
Lyndra’s LYNX™ Drug Delivery Platform
The LYNX™ drug delivery platform is one of the most significant advances in oral drug delivery in decades, creating medicines that last for a week or longer in an oral dosage form. A key aspect of the platform is its ability to deliver the drug consistently, minimizing peaks and troughs of drug levels compared to daily medicine. Based on technology invented in the Langer Lab at MIT, the LYNX™ platform has progressed rapidly since 2015 through preclinical and early human studies and achieved proof of concept of the platform and lead asset in a Phase 2 study. The LYNX™ drug delivery platform has the potential for broad applicability across multiple therapeutic areas – including approved drugs and those currently in development. The LYNX™ drug delivery platform offers the potential to increase adherence and improve health outcomes, while also freeing people from the burden of daily pills and simplifying their lives.
About Lyndra Therapeutics
Lyndra Therapeutics is a clinical-stage biopharmaceutical company pioneering long-acting oral therapies. Lyndra’s initial focus is on developing therapies in central nervous system (CNS) disorders, which would benefit from dramatically reduced dosing frequency. Lyndra’s lead product candidate, oral weekly risperidone (LYN-005), is being developed for the treatment of people living with schizophrenia and bipolar 1 disorder. The company is also committed to advancing its platform to develop multiple oral therapeutics for a broad range of diseases including major public health and global health challenges, with therapies that include oral weekly levomethadone and oral weekly buprenorphine for opioid use disorder, a monthly oral contraception pill and oral biweekly ivermectin for malaria eradication. Since the founding of Lyndra, the company has received funding from the Bill & Melinda Gates Foundation, the NIH, AbbVie and Gilead Sciences, Inc. Lyndra is headquartered in Watertown, MA and has a state-of-the-art GMP manufacturing facility in Lexington, MA. For more information, visit https://lyndra.com.
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1 World Health Organization (WHO). (n.d.) Schizophrenia. https://www.who.int/news-room/fact-sheets/detail/schizophrenia
2 Acosta, F. J., Hernández, J. L., Pereira, J., Herrera, J., & Rodríguez, C. J. (2012). Medication adherence in schizophrenia. World Journal of Psychiatry, 2(5), 74–82. https://doi.org/10.5498/wjp.v2.i5.74
