1. Scrip
  2. >>R&D
  3. >>Clinical Trials

Newron’s Add-On Treatment Shows Promise In Newly Popular Schizophrenia Field

Italian Firm Needs A Partner For Final Phase III

 
• By Mandy Jackson

Newron’s evenamide worked in a Phase II/III trial as an add-on to antipsychotic drugs in patients with inadequate response to monotherapy at a time when schizophrenia has piqued the interest of big pharma.

Young girl covering her face with her hands after reaching a peak of her depression
Evenamide could be the first add-on to antipsychotics for schizophrenia • Source: Shutterstock

Newron Pharmaceuticals S.p.A.’s evenamide bested placebo as an add-on to antipsychotic drugs in schizophrenia patients with inadequate response to an antipsychotic medication alone in the Phase II/III Study 008A, after the company reported positive long-term Phase II results in treatment-resistant schizophrenia (TRS) at the start of 2024. Plans are under way for a Phase III clinical trial in TRS patients, but the company needs a partner to fund the study, which may now be easier to find.

Key Takeaways

  • Newron’s evenamide succeeded in a Phase II/III clinical trial as an add-on to antipsychotic medicines in schizophrenia patients with inadequate responses to monotherapy.

  • Study 008A may be accepted by regulators as one of two pivotal trials. Planning is under way for a Phase III trial in treatment-resistant schizophrenia that may start this year

Schizophrenia and neuropsychiatry have become more popular among big pharma companies recently, with both Bristol Myers Squibb Company and AbbVie Inc. making multibillion-dollar purchases in December 2023 to diversify their portfolios with later-stage assets in the field

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Clinical Trials

Pipeline Watch: Six Approvals And Thirteen Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Viatris Will File ‘Fast-Acting’ Meloxicam For FDA Approval This Year

 
• By Joseph Haas

Seven years after acquiring it, Viatris will seek approval of a meloxicam formulation for acute pain backed by data from two Phase III studies in post-surgical pain settings.

CRISPR Therapeutics Unveils Promising Early In Vivo Cholesterol-Lowering Results

 
• By Andrew McConaghie

The Phase I results are the best to date among ANGPTL3-targeting candidates in the pipeline, but analysts will wait for further updates before predicting a likely winner.

Sanofi R&D Head’s Words Of Wisdom For Biotechs

 
• By Kevin Grogan

Houman Ashrafian tells delegates at Swiss Biotech Day that ‘literally only two things matter in our industry – target credentialing and differentiated pharmacology. The rest is execution.’

More from R&D

Sanofi R&D Head’s Words Of Wisdom For Biotechs

 
• By Kevin Grogan

Houman Ashrafian tells delegates at Swiss Biotech Day that ‘literally only two things matter in our industry – target credentialing and differentiated pharmacology. The rest is execution.’

Marea Eyes Cardioprotective Benefit With ANGPTL4 Inhibition

 
• By Joseph Haas

Phase IIa data for ANGPTL4-targeted antibody shows reduced triglycerides and remnant cholesterol, which Marea asserts indicates potential to protect against cardiovascular outcomes.

First Win For AstraZeneca’s Enhertu In Early-Stage Breast Cancer Treatment

 
• By Andrew McConaghie

Already dominating in later lines of breast cancer treatment, Enhertu could now displace both chemotherapy combinations and Roche’s Kadcyla in early-stage HER2-positive patients.