Newron's Schizophrenia Candidate Scores Mid-Stage Win, Moves to Phase III

schizophrenia

Pictured: Artistic rendering of schizophrenia/iStock, golubovy

New data from Newron Pharmaceuticals’ Phase II study 014/015 showed that its investigational drug evenamide elicits sustained and significant symptom improvements in patients with treatment-resistant schizophrenia, the company announced Monday.

At the six-month follow-up, approximately 40% of patients treated with evenamide experienced substantial symptomatic improvement—so much so that they no longer satisfied the original entry criteria into the study with their disease no longer meeting the qualification for treatment resistance, according to Newron.

In addition, unlike the typical clinical experience, none of the evenamide-treated patients experienced worsening of their psychoses.

Newron CMO Ravi Anand called these findings “highly encouraging” in a statement, pointing out that in the study evenamide’s benefits for treatment-resistant schizophrenia (TRS) “continue to accrue over time, and many patients who do not respond early achieve clinically important benefits later.”

“The findings show that the addition of [evenamide’s] glutamate modulation to first- and second-generation antipsychotics in patients with TRS potentiates their effects on dopamine dysfunction and can potentially produce a beneficial antipsychotic response,” Anand said.

Newron is now preparing to launch a potentially pivotal double-blinded, randomized and placebo-controlled Phase III study of evenamide in this indication.

These new data were presented at the 36th European Clinical Neuropsychopharmacology Congress, and they follow the study’s one-year interim readout posted in February 2023. At the time, evenamide treatment induced a significant 50% improvement in scores in the Positive and Negative Syndrome Scale compared with the candidate’s initial six-week benefit.

Evenamide is an investigational oral drug that works by inhibiting voltage-gated sodium channels. This helps normalize the secretion of glutamate and ease the otherwise overly repetitive neuronal firing in schizophrenia. Unlike other antipsychotic agents, however, evenamide is highly specific and has no detectable activity on some 130 neurotransmitters, enzymes or transporters commonly affected by these medications.

Taking a similar precision approach to neuropsychiatric conditions is Karuna, whose schizophrenia hopeful KarXT is an agonist of the muscarinic acetylcholine 1 receptors M1 and M4. In contrast to all approved schizophrenia treatments, which target the condition’s positive symptoms, KarXT instead addresses negative symptoms such as social withdrawal and apathy toward otherwise normal interests.

Karuna has recently submitted a New Drug Application for KarXT and expects the standard 10- to 12-month review period. If approved, KarXT could become the first new therapeutic mechanism greenlit for schizophrenia in over five decades.  

Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

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