Lyndra Therapeutics Announces Positive Data from Pivotal Phase 3 Study with Oral Weekly Risperidone (LYN-005) for Schizophrenia

WATERTOWN, Mass.--(BUSINESS WIRE)-- Lyndra Therapeutics^®, a clinical-stage biopharmaceutical company, today announced positive data from the STARLYNG-1 (LYN-005-C-301) study, comparing the pharmacokinetic (PK) profile of oral weekly risperidone (LYN-005) with immediate-release Risperdal administered daily to adults living with schizophrenia and schizoaffective disorder. The STARLYNG-1 study is designed to bridge to the previously established safety and efficacy of immediate-release Risperdal for schizophrenia and bipolar disorder as agreed with the U.S. Food and Drug Administration.

The pivotal study included participants with schizophrenia and schizoaffective disorder who were on a stable dose of an oral antipsychotic medication at the start of the study. The study assessed oral weekly risperidone 15 mg and 45 mg, equivalent to 2 mg and 6 mg daily Risperdal, respectively. A total of 90 participants were planned for the study, with a planned interim analysis after 46 participants.

At the interim analysis, the study met the pre-specified primary endpoint, which includes the geometric mean ratio of the Week 5 oral weekly risperidone drug levels compared to the baseline immediate-release Risperdal drug levels. Oral weekly risperidone met the endpoint of a one-sided Cmin of >0.80; a one-sided Cmax of <1.25; and a two-sided Cavg of 0.80-1.40, with 90% confidence limits.

With these positive results, the study was stopped early according to the pre-defined stopping criteria.

“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,” said Lyndra Therapeutics’ Chief Medical Officer and President of Global Product Development Richard Scranton, MD, MPH. “For people who rely on risperidone as part of their treatment regimen, oral weekly risperidone could vastly improve medication adherence and outcomes.”

The study also met its secondary endpoints for safety and Positive and Negative Syndrome Scale (PANSS) score, a score used for measuring symptom severity in schizophrenia.

One key potential benefit of the LYNX drug delivery platform is the ability to deliver more consistent levels of medication compared to daily dosing by reducing the peak to trough variation.

Oral weekly risperidone (LYN-005) was generally safe and well tolerated.

“The LYNX drug delivery platform has the potential to transform how we take oral medicines, and we are very pleased with the positive interim data for our lead asset oral weekly risperidone,” said Jessica Ballinger, Lyndra Therapeutics’ President and CEO. “We are eager to bring long-acting oral therapies to patients and are focused on advancing oral weekly risperidone into its remaining pivotal safety trial in 2024.”

About the STARLYNG-1 (LYN-005-C-301) Study

The STARLYNG-1 study was designed as a ~90-person pharmacokinetic (PK) comparability study that bridges to the previously established safety and efficacy of daily Risperdal. Due to its adaptive study design, at the interim analysis, the study could be stopped for success or continued for sample size re-estimation. The study aimed to evaluate the pharmacokinetics of 15 mg and 45 mg oral weekly risperidone (LYN-005) compared to 2 mg or 6 mg daily Risperdal. Following the STARLYNG-1 pivotal PK study, Lyndra plans to conduct STARLYNG-2, its pivotal safety study, which will be a six-month, double-blind study to characterize the safety profile of Lyndra’s LYNX^® drug delivery platform, beginning in the second half of 2024 in patients with schizophrenia and schizoaffective disorders.

About the LYNX^® Drug Delivery Platform

The LYNX drug delivery platform offers the possibility of transforming how people take pills. Current oral pills are limited to ‘extended release’ formulations, which do not last for more than a day. The once-a-week dosing offered by Lyndra’s LYNX drug delivery platform is enabled by more than 50 patented innovations in design, engineering and materials science to achieve this dramatically reduced dosing frequency. The platform originated from the Langer Laboratory, with which Lyndra has an exclusive technology license.

About Lyndra Therapeutics

Lyndra Therapeutics is a clinical-stage biopharmaceutical company pioneering long-acting oral therapies. Lyndra’s 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. Lyndra’s initial focus is on developing therapies in psychiatry, cardiometabolic diseases and other conditions that 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. Since the founding of Lyndra, the company has received product 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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