DGAP-News

Newron provides H1 2022 results and updates on R&D and business activities

DGAP-News: Newron Pharmaceuticals S.p.A. / Key word(s): Half Year Report Newron provides H1 2022 results and updates on R&D and business activities 15.09.2022 / 07:00 CET/CEST The issuer is solely responsible for the content of this announcement. Milan, Italy, September 15, 2022, 7 am CET – Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced its financial results and operational highlights for the half year ended June 30, 2022 and provided an update on its R&D and business activities.

Highlights H1 2022:

Evenamide (Schizophrenia)

• Key data presented at the 33rd CINP Hybrid World Congress of Neuropsychopharmacology, Taipei, Taiwan, including:
  • Encouraging interim data from the first 100 patients in study 014, a world-first, randomized, open-label trial of evenamide as an add-on to an antipsychotic in patients with chronic, treatment-resistant schizophrenia (TRS). Results showed the addition of evenamide improved symptoms of psychosis. Enrollment in this study is expected to be completed by end of 2022 and results are expected in QI 2023
  • Study design for an upcoming potentially pivotal, randomized, double-blind, placebo-controlled, eight-week, global study (003) assessing the safety and efficacy of evenamide as an add-on treatment in patients with TRS, which is expected to commence in 2023
  • Safety data from more than 400 healthy volunteers and patients with schizophrenia treated with evenamide, showing that the compound is safe and well tolerated
• The first potentially pivotal study of the Phase II/III evenamide development program, study 008A with evenamide as add on therapy in patients with chronic schizophrenia experiencing inadequate response to their current antipsychotics, is continuing to enroll patients, and results are expected in first half of 2023
• Newron continues to evaluate strategic commercial and development partnering options for evenamide

Xadago/Safinamide (Parkinson’s disease)