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Minerva advances phase 3, 4 trials of MIN-101 for schizophrenia
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Following a recent meeting with the FDA, Minerva Neurosciences Inc. announced updated plans for phase 3 and 4 clinical development of MIN-101 for schizophrenia.
“We are very excited to be taking MIN-101 into a pivotal phase 3 trial, which has the potential to identify a new approach to the treatment of schizophrenia and improve the quality of life for millions of patients,” Remy Luthringer, PhD, president and CEO of Minerva, said in a press release. “Our development strategy for MIN-101 is driven by the recognition that, while positive symptoms are present intermittently and are a hallmark of early schizophrenia, negative symptoms persist and worsen over the lifetimes of the majority of schizophrenic patients, severely limiting their social and vocational reintegration over the longer term. No drugs are currently approved to treat the negative symptoms of schizophrenia or negative symptoms present in other conditions, including developmental disorders, affective disorders and neurodegenerative disorders.”
Findings from the phase 2 study informed the design of the phase 3 trial, according to the release. These included a direct effect on negative symptoms that endured the entire 36-week trial.
Specificity of MIN-101 efficacy for negative symptoms was confirmed by stability of positive symptoms throughout treatment and comparable side effects with placebo.
Researchers expect to enroll 500 participants from approximately 60 clinical sites across the U.S. and Europe.
The phase 3 trial will include some features of the phase 2b trial, such as improvement in negative symptoms as a primary endpoint; monotherapy administration of MIN-101 and no co-administration with atypical antipsychotics; participants with moderate-to-severe negative symptoms; and a 12-week, double-blind, randomized, placebo-controlled core phase followed by an open-label extension phase.
During the phase 3 trial, two doses of MIN-101 will be delivered during the double-blind phase, followed by an optional 36-week extension in which all participants will receive MIN-101.
The phase 3 trial was designed to replicate the “real world” experience in clinical practice in schizophrenia.
Minerva plans to conduct additional trials during phase 4 development to expand the profile of MIN-101 to potentially include psychosis relapses and high-risk adolescents who manifest negative symptoms during the prodromal stage.
Further, the company plans to explore MIN-101 for neurodegenerative disorders such as Alzheimer’s disease, Parkinson’s disease, mood disorders, schizophrenia spectrum disorders and autism spectrum disorders.