A pivotal clinical trial testing a weekly oral dosing of risperidone (LYN-005) for patients with schizophrenia has begun with the dosing of the first participant.¹

Lyndra Therapeutics is developing the trial using the LYNX drug delivery platform to enable week-long dosing that can be delivered in a single oral capsule of risperidone, 1 of the most common treatments for patients with schizophrenia.

The Study

In the pharmacokinetic comparability study, the investigators are evaluating weekly doses of the treatment that are equivalent of 2-6 mg of daily risperidone.

“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,” said Nayana Nagaraj, MD, MPH, PhD, Senior Medical Director, Clinical Research at Lyndra Therapeutics, in a statement. “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 Drug Delivery Platform

The LYNX drug development platform is able to deliver drug consistently, while minimizing peaks and troughs of drug levels compared to daily medicine. The platform is based on new technology from the Langer Lab at the Massachusetts Institute of Technology and has improved since 2015 through preclinical and early human studies.

The platform also achieved proof of concept and was the lead asset in a recent phase 2 trial.

Risperidone is also being evaluated as a treatment for patients with schizoaffective disorder and bipolar I disorder.

A Lack of Adherence

One of the major reasons there is a need for more weekly treatments for patients with schizophrenia is that there tends to be a lack of medication adherence in this space.

In a recent survey, nearly 100% of patients and caregivers who responded reported moderate to severe challenges taking their medications as prescribed.

A lack of adherence is related to a number of negative outcomes including triggering relapse.

There are currently only long-acting medicines available for patients with schizophrenia in an injectable formulation.

However, these are not being used by the majority of patients with schizophrenia.

“Poor or partial adherence to prescribed medications remains a frequent cause of relapse and hospitalization in people living with schizophrenia,” said John M. Kane, MD, 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."

A Recent

Earlier this month, the US Food and Drug Administration (FDA) has approved risperidone (UZEDY) for the treatment of adult patients with schizophrenia as an extended-release injectable suspension treatment.²

The treatment, developed by Teva Pharmaceuticals, represents the first subcutaneous, long-acting formulation of risperidone that used a copolymer technology called SteadyTeq to control the steady release of the drug. Therapeutic blood concentrations using this technology can be reached within 6-24 hours of a single dose of risperidone.

The approval is based on the results of a pair of phase 3 trials--TV46000-CNS-30072 (the RISE Study – The Risperidone Subcutaneous Extended-Release Study) and TV46000-CNS-30078 (the SHINE Study – A Study to Test TV-46000 for Maintenance Treatment of Schizophrenia).

References:

1. Lyndra Therapeutics doses first clinical trial participant in Pivotal Study of Oral Weekly Risperidone (Lyn-005) for schizophrenia and schizoaffective disorder. Business Wire. (2023, May 9). https://www.businesswire.com/news/home/20230508005764/en/Lyndra-Therapeutics-Doses-First-Clinical-Trial-Participant-in-Pivotal-Study-of-Oral-Weekly-Risperidone-LYN-005-for-Schizophrenia-and-Schizoaffective-Disorder?_gl=1%2Aln84sw%2A_ga%2AMTM5MTMzNTMyNy4xNjYzNTkyNTg3%2A_ga_ZQWF70T3FK%2AMTY4MzYzNzMyMS4zMS4xLjE2ODM2MzczNDEuNDAuMC4w

2. Walter, K. (2023, May 1). FDA approves risperidone for adults with schizophrenia. HCP Live. https://www.hcplive.com/view/fda-approves-risperidone-adults-schizophrenia