Newron Pharmaceuticals Reports Positive Data on Schizophrenia Drug

Newron Pharmaceuticals, a biopharmaceutical company specializing in nervous system therapies, has shared significant updates on its novel drug, evenamide, and financial results for the first half of 2024. The company, based near Milan, Italy, revealed promising trial data, particularly for patients with treatment-resistant schizophrenia (TRS), and outlined key financial and operational achievements.

Promising Schizophrenia Treatment: Evenamide

In H1 2024, Newron reported final results from its Phase II trial (study 014/015) evaluating evenamide, a drug aimed at improving outcomes for patients with TRS. The study demonstrated clinically significant, sustained improvements in patients, with 70% showing meaningful reductions in disease severity. Notably, 25% of participants achieved remission—a remarkable outcome never previously seen in this patient group.

Additionally, Newron disclosed data from study 008A, which assessed evenamide in patients with chronic schizophrenia. This four-week randomized trial showed statistically significant improvements in symptoms when evenamide was added to second-generation antipsychotic treatments. These findings further validate the drug's safety and efficacy.

Newron is preparing for a Phase III trial of evenamide, aiming to assess long-term outcomes in at least 400 patients with TRS. The study is expected to begin in 2025, positioning the drug for potential regulatory approval.

Strategic Focus on Partnerships and Expansion

As Newron progresses evenamide, it is actively exploring partnerships to fund the next stage of clinical trials. The company has received multiple offers for licensing agreements and expects to finalize a transaction soon, which will drive further development of evenamide.

Additionally, Newron continues to develop and market its Parkinson’s disease treatment, Xadago® (safinamide), in collaboration with global partners. Recent settlements with generic drug manufacturers will delay competition in the U.S. market until 2027, allowing Newron and its partners to continue capitalizing on the drug’s commercial potential.

Financial Performance in H1 2024

Newron’s financial results for the first half of 2024 were marked by a net loss of EUR 9.6 million, compared to EUR 7 million in the same period the previous year. The company’s R&D expenses rose to EUR 6.5 million, driven by ongoing clinical trials. Cash reserves at the end of June 2024 stood at EUR 12.2 million, sufficient to fund operations well into 2025.

Looking Ahead

Newron remains focused on advancing evenamide through its Phase III trial, believing the drug holds blockbuster potential for treating schizophrenia patients underserved by current therapies. The company also aims to expand its pipeline, exploring further opportunities in the central nervous system (CNS) treatment space.

CEO Stefan Weber expressed optimism, stating, “We believe evenamide has the potential to bring enormous benefits to patients and create significant value for shareholders.” Newron plans to provide updates on its partnership negotiations and pipeline developments in the coming months.

With the positive results from its schizophrenia trials and a strategic plan for growth, Newron Pharmaceuticals is poised for a pivotal period as it advances its innovative therapies for nervous system disorders.