" class="no-js "lang="en-US"> Lyndra Therapeutics Doses in Clinical Trial for Schizophrenia
Friday, June 09, 2023

Lyndra Therapeutics Doses First Clinical Trial Participant in Pivotal Study of Oral Weekly Risperidone (LYN-005) for Schizophrenia and Schizoaffective Disorder

Lyndra Therapeutics, a clinical-stage biopharmaceutical company working to make daily pills a thing of the past, today announced it has dosed the first participant in its pivotal clinical trial investigating oral weekly risperidone (LYN-005), to provide a new treatment option for patients living with schizophrenia, schizoaffective disorder and bipolar I disorder.

Lyndra’s LYNX™ drug delivery platform is designed to enable a week-long dose of risperidone to be delivered in a single oral capsule. The oral daily form of risperidone is one of the most prescribed treatments for people living with schizophrenia and bipolar I disorder.

“At Lyndra, our development pipeline focuses on health conditions where reducing the dosing frequency and delivering the drug more consistently could have a significant impact,” said Richard Scranton, M.D., M.P.H., Chief Medical Officer of Lyndra Therapeutics. “People living with schizophrenia and other serious mental health conditions need more patient-centric treatment options that can help address challenges like poor medication adherence and relapse.”

“Clinicians involved in the trial are eager to see the impact that LYN-005, powered by the LYNX™ platform, may have on increasing medication adherence, reducing relapses and improving outcomes,” added Nayana Nagaraj, M.D., M.P.H., Ph.D., Senior Medical Director, Clinical Research at Lyndra Therapeutics. “We believe LYN-005 and other long-acting oral therapies powered by LYNX™ have the potential to improve therapeutic outcomes while simultaneously freeing people from the burden of taking daily medicines.”

The oral weekly risperidone pivotal trial is a pharmacokinetic (PK) comparability study evaluating weekly doses of risperidone from LYN-005 that are equivalent to 2 and 6 milligrams of daily risperidone. This trial bridges to previously established safety and efficacy of immediate release (daily) risperidone.

While antipsychotic medicines such as risperidone have been shown to control both positive and negative symptoms of schizophrenia, medication adherence is a major challenge for patients and a goal of clinical treatment. A recent survey of patients and caregivers demonstrated the challenges of daily medication regimens, with nearly 100% of respondents reporting moderate to severe challenges taking their medications as prescribed1. A review of the unmet needs and challenges in the treatment of patients living with schizophrenia noted that a lack of treatment or poor medication adherence can worsen disease symptoms, including triggering relapse — further emphasizing the need for patient-friendly treatment options as a priority for people living with schizophrenia.

Currently, the only long-acting medicines available for schizophrenia require injections, but data show that they are used by a minority of patients. “Poor or partial adherence to prescribed medications remains a frequent cause of relapse and hospitalization in people living with schizophrenia,” said John M. Kane, M.D., professor, Department of Psychiatry at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, and advisor to Lyndra. “The availability of a long-acting oral formulation would be a very welcome addition to our therapeutic armamentarium.”

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