Lyndra Therapeutics yesterday announced positive results from a Phase 2 study of its once-weekly, oral schizophrenia treatment.
Watertown, Mass.-based Lyndra’s oral, long-acting, extended-release risperidone capsule, LYN-005, is designed for the weekly treatment of schizophrenia.
Data from the company’s first repeat-dose Phase 2 study demonstrate that LYN-005 offered sustained therapeutic levels of risperidone over the one-week dosing intervals while also reducing peak drug exposure relative to immediate-release risperidone, according to a news release.
The multiple-dose, randomized, parallel-group, placebo-controlled study assessed the safety, tolerability and pharmacokinetics of Lyndra’s LYN-005 capsule in 32 clinically stable patients with a primary diagnosis of schizophrenia or schizoaffective disorder.
Included in the study was a lead-in period in which patients received immediate-release risperidone tablets (2 mg or 4 mg) for 13 days in order to achieve a steady therapeutic state. After the lead-in, patients were randomized 3:1 to receive weekly capsules (14 mg or 28 mg) with daily immediate-release risperidone-matched placebo or daily immediate-release risperidone (2 mg or 4 mg) with weekly extended-release risperidone matched placebo for three weeks.
Primary endpoints in the study were incidence of treatment-emergent adverse events and plasma concentrations of active moiety after repeat doses of the capsule, relative to immediate-release 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,” Lyndra Therapeutics CMO Dr. Richard Scranton said in the release. “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 non-adherence across a variety of important disease areas.”