WATERTOWN, Mass.--(BUSINESS WIRE)--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). Lyndra is developing 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 relapse2 -- 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."
The initiation of this clinical trial is a step toward bringing the promise of long-acting oral therapies to people living with mental health conditions and their caregivers, for whom an oral-weekly option may provide significant benefits.
About Oral Weekly Risperidone (LYN-005)
Oral weekly risperidone (LYN-005) is being developed for the treatment of people living with schizophrenia and bipolar I disorder. Oral weekly risperidone uses Lyndra’s innovative LYNX™ drug delivery platform to provide single weekly doses as an alternative to daily risperidone. Phase 2 data for oral weekly risperidone demonstrated that the active moiety quickly reached therapeutic levels in patients, provided sustained drug levels for repeated one-week dosing intervals, and reduced peak drug exposure. Oral weekly risperidone has the potential to be the first-ever long-acting oral therapy for the treatment of people with schizophrenia and bipolar 1 disorder.
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.3 Schizophrenia typically manifests as hallucinations, delusions and disorganized thoughts and behavior. Medication non-adherence, estimated to be around 50%,4 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.
Patient Unmet Needs Survey (Q3’21; n=1645 patients and caregivers)
Goldstone, L.W. (2020). Unmet medical needs and other challenges in the treatment of patients with schizophrenia. The American Journal of Managed Care, 26(3). https://www.ajmc.com/view/unmet-medical-needs-and-other-challenges-in-the-treatment-of-patients-with-schizophrenia-
World Health Organization (WHO). (n.d.) Schizophrenia. https://www.who.int/news-room/fact-sheets/detail/schizophrenia
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