New Era in Schizophrenia Treatment: Lyndra's Weekly Oral Pill Shows Promising Results

In a significant advancement in the treatment of schizophrenia, Lyndra Therapeutics' Phase 3 study of oral weekly risperidone (LYN-005) has shown promising results. Demonstrating efficacy comparable to daily Risperdal, the STARLYNG-1 study was halted early due to positive outcomes, suggesting improved patient adherence and more consistent medication levels.

This breakthrough, utilizing the LYNX® drug delivery platform, represents a significant advancement in managing schizophrenia and schizoaffective disorder. It has the potential to revolutionize treatment methods and promises to enhance the quality of life for patients.

The STARLYNG-1 study, aiming to align with the established safety and efficacy of immediate-release Risperdal, involved adults diagnosed with schizophrenia and schizoaffective disorder. These participants, already on a stable dose of oral antipsychotics, were administered either 15 mg or 45 mg of oral weekly risperidone, equating to 2 mg and 6 mg daily of Risperdal. The study originally planned to enroll 90 participants, with an interim analysis after 46 participants.

This interim analysis proved to be a turning point. The study met its primary endpoint: the geometric mean ratio of Week 5 oral weekly risperidone drug levels in comparison to baseline immediate-release Risperdal drug levels. The results confirmed that a single dose of oral weekly risperidone achieves comparable medication levels to daily Risperdal, a significant stride in psychiatric medication management. Given these positive results, the study was halted early, adhering to pre-defined stopping criteria.

Dr. Richard Scranton, Chief Medical Officer at Lyndra Therapeutics, highlighted that the LYNX® drug delivery platform, which enables this weekly dosing, could significantly improve medication adherence and outcomes for patients dependent on risperidone. “These positive data demonstrate that a single dose of oral weekly risperidone delivers comparable medication levels to daily risperidone, validating that Lyndra’s LYNX® drug delivery platform may provide a medication option that significantly reduces dosing frequency.”

Additionally, the study met secondary endpoints concerning safety and the Positive and Negative Syndrome Scale (PANSS) score, a critical metric for assessing symptom severity in schizophrenia. The new formulation, oral weekly risperidone (LYN-005), was generally well-tolerated and considered safe.

The LYNX® Drug Delivery Platform promises more consistent medication levels compared to daily dosing by minimizing peak to trough variation. This platform, arising from over 50 patented innovations in design and materials science, signifies a leap forward from the current extended-release formulations which last no more than a day.

Looking ahead, Lyndra Therapeutics plans to commence the STARLYNG-2 study, a pivotal safety trial, in the latter half of 2024. This six-month, double-blind study will further evaluate the safety profile of the LYNX® drug delivery platform in patients with schizophrenia and schizoaffective disorders.

Jessica Ballinger, President and CEO of Lyndra Therapeutics, expressed optimism about the potential of the LYNX platform to transform oral medication administration. The successful interim data for oral weekly risperidone paves the way for long-acting oral therapies, offering a new horizon of hope for patients and healthcare providers alike.

The positive results from the STARLYNG-1 study represent a potential paradigm shift in the treatment of schizophrenia. The once-a-week oral medication not only promises enhanced efficacy and safety but also holds the key to improving patients' adherence to treatment, thereby potentially improving the overall quality of life.

About Author: Hüseyin Kandemir

As a medical journalist with over 20 years of experience, I have served as an Editor and Reporter for various magazines, newspapers, and online broadcasting platforms, consistently demonstrating a strong commitment to excellence in journalism. My specialization includes medical science, digital health, AI for health, data science, and biotechnology.