Newron begins first potentially pivotal schizophrenia study
pharmafile | September 6, 2021 | News story | Sales and Marketing |
Newron has initiated Study 008A, the first potentially pivotal study with evenamide in patients with schizophrenia.
Study 008A, a four-week, randomised, double-blind placebo-controlled international study, is designed to evaluate the efficacy, tolerability, and safety of the 30mg BID therapeutic dose of evenamide in patients with chronic schizophrenia, currently being treated with a second-generation antipsychotic.
Newron plans to randomise at least 200 patients in study centers in Europe, Asia and Latin America. Results from the study are expected by Q4 2022.
This study is part of Newron’s Phase III evenamide clinical trial program that targets patients with schizophrenia experiencing worsening of psychosis on therapeutic doses of atypical antipsychotics, as well as treatment-resistant patients.
Ravi Anand, MD, Newron’s CMO, said: “Evenamide has been shown to be safe in studies treating more than 300 healthy volunteers and patients at doses of up to 60mg.
“Study 008A will now evaluate the efficacy, tolerability, and safety of the therapeutic dose of 30mg BID. If successful, Newron believes the study would qualify as the first adequate and well-controlled (pivotal) study with evenamide in patients with schizophrenia who are inadequate responders to antipsychotics.
“Evenamide would currently be the first add-on therapy approved for the treatment of patients with positive symptoms of schizophrenia, and its unique glutamatergic inhibition mechanism of action offers a truly innovative therapeutic option to those patients who are not benefitting from their current antipsychotics.”
Newron is currently evaluating potential options for partnering/co-developing the further development of evenamide.