Newron sees promise in schizophrenia drug

Dive Brief:

  • Italian biopharma Newron Pharmaceuticals on Tuesday said it believes early results from a Phase 2a study of its schizophrenia drug evenamide support further testing in larger studies of more advanced patients. 
  • Evenamide, a voltage-gated sodium channel blocker, was given to 89 patients experiencing breatkhrough psychotic symptoms while on stable doses of Johnson & Johnson's Risperdal (risperidone) or Otsuka's Abilify (aripiprazole), two commonly used anti-psychotics.
  • Treatment with evenamide was generally well-tolerated, although two patients discontinued treatment due to seizure and atrial fibrillation, respectively. The study was designed to assess safety and preliminary efficacy. 

Dive Insight:

The schizophrenia market is highly competitive.

Drugs such as Risperdal or Abilify are common treatments even as older drugs such as chlorpromazine (available since the 1950s) remain in use. 

One of the key challenges, however, is compliance. According to GlobalData, compliance is the most common reason behind relapse. The very nature of the disease can trigger relapse as the persuasive nature of 'voices' and hallucinations can cause patients to stop taking medication. 

Evenamide, an oral drug, has a different mechanism of action to other available antipsychotics. It is in development as an add-on to existing schizophrenia treatments, and the company hopes that it will have potential to address harder-to-treat negative symptoms of the disease. 

Dopamine-blocking antipsychotics, such as Invega (paliperidone) and Risperdal (risperidone) can cause a wide range of side effects, adding to the already challenging issue of compliance. These didn't show up in Newron's study, which the company interpreted as positive for the drug's prospects.

"Evenamide was not associated with any dose-limiting toxicities, or the extrapyramidal, sexual, endocrine, and metabolic side effects associated with dopamine-blocking antipsychotics," said Ravi Anand, company chief medical officer.

A cleaner safety profile could give evenamide potential for long-term use in addition to existing drugs.

Newron will present more detailed results at the International Congress on Schizophrenia Research in March. 

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Filed Under: Clinical Trials