Japanese pharma company Sumitomo Dainippon has announced its drug Lonasen (blonanserin) has achieved its primary endpoint in a Phase III trial of 150 adolescents with schizophrenia.
Participants of the Phase III trial were randomised into three groups: one group received one 8mg dose per day, the second received a 16mg daily dose and the third was the placebo group.
The 16mg per day group showed a statistically significant improvement in the Positive and Negative Syndrome Scale (PANSS) total score over the six week period – the primary endpoint – compared to placebo. Although the 8mg group did demonstrate improvement in PANSS score over the placebo, the improvement was not statistically significant.
The PANSS score aims to capture the overall mental status of the condition. It measures 30 symptoms; seven of which are positive, another seven are negative and 16 are general psychopathological.
Lonasen is an oral, atypical antipsychotic discovered and developed by Sumitomo Dainippon. The drug has an affinity for dopamine D2/D3 receptors, as well as serotonin 5-HT2A receptors in clinical studies.
It has been approved in Japan for a decade to treat adults with schizophrenia. As a result of these most recent results, Sumitomo Dainippon plants to submit a supplemental new drug application to the Japanese Ministry of Health, Labour and Welfare in 2020 to expand Lonasen’s indication to include adolescent patients.
Acceptance of this label expansion would make Lonasen the first drug approved for schizophrenic adolescents in Japan.
This positive step for Sumitomo Dainippon comes a few days after it announced it was entering into negotiations to acquire Australian clinical stage, stem cell and regenerative medicine-focused Cynata. Sumitomo Dainippon is considering acquiring all shares of Cynata at the price of AUS$2 per share in cash.
As a result, Cynata has granted non-exclusive due diligence access to the Japanese company, while also continuing to engage with other interested parties.