Extended-Release Risperidone Capsule Making Waves

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Lyndra Therapeutics announced results from its phase 2 study of the extended-release (ER) risperidone capsule, LYN-005, in an oral presentation at the 2021 Congress of Schizophrenia International Research Society (SIRS).

LYN-005 is an oral, long-acting, ER risperidone capsule for the weekly treatment of schizophrenia. The presented data demonstrates LYN-005 both maintained therapeutic levels of risperidone over 1-week dosing intervals and reduced drug exposure relative to that of immediate release (IR) risperidone.

“These data, along with additional safety data from more than 200 administrations of the Lyndra ER capsule from 10 studies, add to our momentum as we move down the development pathway with plans to conduct our end of phase 2 meeting with the FDA this summer and initiate a pivotal study of LYN-005 in schizophrenia in the second half of this year,” said Richard Scranton, MD, MPH, chief medical officer of Lyndra Therapeutics. “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 nonadherence across a variety of important disease areas.”¹

The phase 2 study of LYN-005 was multiple-dose, randomized, and placebo-controlled. It included 32 participants with a primary diagnosis of schizophrenia or schizoaffective disorder. Treatment assignment was blinded, but dose level was not. In order to achieve a steady therapeutic state, patients received either 2 mg or 4 mg IR risperidone tablets for 13 days during a lead-in period. Following the lead-in, patients were randomized 3:1 to receive weekly LYN-005 capsules (14 mg or 28 mg), along with daily IR risperidone-matched placebo or daily IR risperidone (2 mg or 4 mg) with weekly ER risperidone-matched placebo for 3 weeks.

LYN-005 is designed to provide consistent drug levels for an entire week from a single capsule. No oral therapy has achieved this before.

“Of the 2.2 million people suffering from schizophrenia in the US, approximately 50% of those receiving treatment may be nonadherent within the first year of treatment, and a majority will relapse within the first 5 years of receiving that treatment. Preventing relapse is important in reducing overall healthcare costs and in preserving functioning in individuals with schizophrenia,” said David Walling, PhD, chief clinical officer at Apex Innovative Sciences, chief executive officer and principal investigator of CNS Research, and study presenter at SIRS. "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.”¹

Lyndra intends to meet with the US Food and Drug Administration to discuss clinical path and pivotal clinical trial design.

Reference

1. Lyndra Therapeutics. Lyndra Therapeutics presents promising phase 2 data on once-weekly oral risperidone treatment, LYN-005, in development for schizophrenia. News release. April 18, 2021. https://www.biospace.com/article/releases/lyndra-therapeutics-presents-promising-phase-2-data-on-once-weekly-oral-risperidone-treatment-lyn-005-in-development-for-schizophrenia/