A Phase II schizophrenia treatment is showing promise for patients diagnosed with this complex and chronic brain disorder.
A Phase II schizophrenia treatment is showing promise for patients diagnosed with this complex and chronic brain disorder. The drug developed by Lyndra Therapeutics demonstrated it could provide sustained and extended levels of a commonly used medication for the condition.
Over the weekend, Lyndra Therapeutics announced its oral treatment provided substantial, sustained therapeutic levels of risperidone, an antipsychotic commonly used to treat schizophrenia and bipolar disorder. The company said the drug could play a key role in treatment compliance.
Lyndra’s LYN-005 is a once-per-week medication. If trial data continues to pan out in Phase III studies, the drug could become a popular choice for prescribers because patients will not be required to take medications daily.
Schizophrenia is a mental illness caused by an imbalance in the neurotransmitters facilitating the communication between neurons in the brain. That imbalance causes schizophrenia patients to perceive things that are not real. People with schizophrenia experience disturbed thoughts, emotions and behavior, finding it difficult to judge reality.
On Sunday, Watertown, Mass.-based Lyndra presented the Phase II data during the 2021 Congress of the Schizophrenia International Research Society meeting. The data demonstrated LYN-005 quickly reaches therapeutic levels in patients, provides sustained risperidone drug levels for repeat one-week dosing intervals, and reduces peak drug exposure, the company said.
With LYN-005, a proprietary extended-release oral capsule, sustained levels of risperidone are delivered into a patient that is expected to last for at least one week or longer, the company said. These levels from a single dose are something no oral therapy has ever achieved before, Lyndra said. The company added that the sustained levels of risperidone from a single dose can improve drug compliance and adherence for people with schizophrenia or schizoaffective disorder.
Richard Scranton, Lyndra’s chief medical officer, said the data from the Phase II study provides momentum for the company as it prepares to meet with the U.S. Food and Drug Administration regarding a pivotal Phase III study of LYN-005 in schizophrenia later this year.
“We look forward to demonstrating the unique clinical value a novel treatment option like LYN-005 could have for people with schizophrenia or schizoaffective disorder as we work to reinforce the broad potential of Lyndra’s breakthrough oral medication platform to address medication non-adherence across a variety of important disease areas,” Scranton said in a statement.
There are approximately 2.2 million people in the United States who have schizophrenia. About half of those patients who receive treatment are likely to become non-adherent to their medication schedule within the first year of treatment. A majority of the schizophrenia patients will relapse within the first five years of receiving treatment due to non-adherence, Dr. David Walling, chief clinical officer at Apex Innovative Sciences, chief executive officer and principal investigator of CNS Research, said.
“Preventing relapse is important in reducing overall healthcare costs and in preserving functioning in individuals with schizophrenia. These data are very promising as, in addition to improving adherence, weekly oral risperidone treatment may provide more consistent plasma drug levels than daily dosing,” Walling said in a statement.
