ISIN:IT0004147952
EQS-News: Newron reports exceptional one-year results of study 014/15 with evenamide in treatment-resistant schizophrenia (TRS)
The data demonstrated that treatment with evenamide was associated with sustained clinically significant benefit that increased throughout the one-year course of treatment.
- The data demonstrated that treatment with evenamide was associated with sustained clinically significant benefit that increased throughout the one-year course of treatment.
- In contrast to common clinical experience, no patient “relapsed” during the one-year treatment period.
- 25% of all patients achieved “remission” (see “About remission”), never described before in TRS patients.
- The presentation for this conference call can be downloaded as of today, January 4, 2024, at 7 am CET, on Newron’s website ( https://www.newron.com/investors/reports-and-presentation/year/2024 ).
EQS-News: Newron schließt Rekrutierung von Schizophrenie-Patienten für potenziell zulassungsrelevante Studie 008A mit Evenamide ab
EQS-News: Newron completes enrollment of schizophrenia patients in potentially pivotal study 008A with Evenamide
290 patients participate at study centers in Europe, Asia and Latin America
- 290 patients participate at study centers in Europe, Asia and Latin America
Milan, Italy, December 29, 2023, 07:00 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 the completion of patient enrollment in study 008A, its potentially pivotal study with evenamide in patients suffering from schizophrenia. - Study 008A is a four-week, randomized, double-blind and placebo-controlled study assessing the efficacy, tolerability, and safety of evenamide (30 mg bid) in patients with chronic schizophrenia currently being treated with a second-generation antipsychotic, but who demonstrate an inadequate response to that treatment.
- A total of 290 patients were enrolled at study centers in Europe, Asia and Latin America.
- If positive, study 008A would be the first well-controlled study to demonstrate the clinical utility of evenamide in schizophrenia patients who show an inadequate response to treatment with atypical antipsychotics.
EQS-News: Newron TRS-Studie, 6-Monatsergebnisse: Evenamide verbessert Patienten in einem Ausmaß, dass sie nicht länger die Auswahlkriterien der Studie erfüllen
EQS-News: Newron TRS study 6 months’ results: Evenamide substantially improves patients to an extent that they no longer meet protocol entry criteria
Newron TRS study 6 months’ results: Evenamide substantially improves patients to an extent that they no longer meet protocol entry criteria
- Newron TRS study 6 months’ results: Evenamide substantially improves patients to an extent that they no longer meet protocol entry criteria
The issuer is solely responsible for the content of this announcement. - 95% of patients completed six weeks of treatment, 94% of the completers chose to continue with evenamide treatment into the long-term extension study (Study 015) and 92% of them reached six months of treatment.
- In contrast to common clinical experience, no patients experienced worsening of their psychoses; consequently, no patients relapsed.
- Review of the efficacy data indicated that treatment with evenamide resulted in approximately 40% of patients, at six months, no longer meeting the protocol severity criteria used to diagnose treatment resistance.
EQS-News: Newron appoints Margarita Chavez as board advisor
Margarita Chavez, former Managing Director at AbbVie Ventures, to be nominated for election to the Board of Directors at the Ordinary AGM 2024
- Margarita Chavez, former Managing Director at AbbVie Ventures, to be nominated for election to the Board of Directors at the Ordinary AGM 2024
Milan, Italy, October 2, 2023 – 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 (CNS) system, today announced that Margarita Chavez has been appointed as an advisor to the Board of Directors of Newron, bringing significant pharmaceutical business development (BD) and dealmaking expertise. - It is intended that Margarita Chavez will be nominated for election to the Board of Directors at Newron’s next Ordinary Annual General Meeting (AGM) of Shareholders in spring 2024.
- Margarita Chavez brings to Newron over 20 years of dealmaking expertise and leadership in the pharmaceutical industry.
- Ulrich Köstlin, Chairman of the Board of Directors of Newron, commented: “We are delighted that Margarita will be supporting us with her vast international dealmaking expertise as a Board advisor and we are convinced that she will as of the AGM 2024 significantly strengthen our Board of Directors as new member.
EQS-News: Newron ernennt Margarita Chavez zur Beraterin des Verwaltungsrates
EQS-News: Newron announces H1 2023 results and provides R&D update
We have reported three striking sets of data from our evenamide development program for treatment-resistant schizophrenia (TRS), presented these results at international psychiatry scientific conferences, and published key results in a peer-reviewed journal.
- We have reported three striking sets of data from our evenamide development program for treatment-resistant schizophrenia (TRS), presented these results at international psychiatry scientific conferences, and published key results in a peer-reviewed journal.
- Study 008A is continuing to enroll patients in this indication, and results are expected by end of 2023/early in 2024.
- The results seen validate the rule of glutamate release inhibition in repairing disturbed neural connectivity in the TRS population.
- Financial Summary (IFRS) H1 2023 and H1 2022: