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EQS-News: Newron TRS study 6 months’ results: Evenamide substantially improves patients to an extent that they no longer meet protocol entry criteria

Retrieved on: 
Tuesday, October 17, 2023

Newron TRS study 6 months’ results: Evenamide substantially improves patients to an extent that they no longer meet protocol entry criteria

Key Points: 
  • 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.

Newron TRS Study 6 Months’ Results: Evenamide Substantially Improves Patients to an Extent That They No Longer Meet Protocol Entry Criteria

Retrieved on: 
Monday, October 9, 2023

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.

Key Points: 
  • 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.
  • These results have expedited the design of a potentially pivotal, Phase III randomized, double-blind, placebo-controlled study of two doses of evenamide (15 and 30 mg bid) as an add-on treatment in patients with TRS.

Brandi Carlile, Adam Lambert, Big Freedia, Ciara, Billy Porter, Hayley Kiyoko, Kesha, Kelsea Ballerini and More Join P&G and iHeartMedia’s “Can’t Cancel Pride 2023 – The Future Starts Now” Hosted by JoJo Siwa on June 15

Retrieved on: 
Thursday, May 18, 2023

This year, the event will once again be hosted by singer, actress and social media phenom JoJo Siwa .

Key Points: 
  • This year, the event will once again be hosted by singer, actress and social media phenom JoJo Siwa .
  • In 2022 alone, Can’t Cancel Pride reached 20 million viewers and listeners.
  • iHeartMedia radio stations will air spots encouraging listeners to tune into the livestream on June 15 and watch the event on demand.
  • Additional proud partners of “Can’t Cancel Pride” include Harris Teeter, Native, OLAY®, Walmart and Vicks®, with more to be announced.

ProQR Announces First Quarter 2023 Operating and Financial Results

Retrieved on: 
Tuesday, May 16, 2023

(Nasdaq: PRQR) (ProQR), a company dedicated to changing lives through transformative RNA therapies based on its proprietary Axiomer® RNA editing technology platform, today reported its financial and operating results for the first quarter ended March 31, 2023, and provided a business update.

Key Points: 
  • (Nasdaq: PRQR) (ProQR), a company dedicated to changing lives through transformative RNA therapies based on its proprietary Axiomer® RNA editing technology platform, today reported its financial and operating results for the first quarter ended March 31, 2023, and provided a business update.
  • Research and development (R&D) costs were €6.1 million for the quarter ended March 31, 2023 compared to €13.4 million for the same period last year.
  • General and administrative costs were €4.0 million for the quarter ended March 31, 2023 compared to €4.9 million for the same period last year.
  • For further financial information for the period ended March 31, 2023, please refer to the financial statements appearing at the end of this release, or the Q1 financial report filing.

Newron Presents Exciting New Data From Study 014/015 at CINP World Congress of Neuropsychopharmacology and the 2023 Congress of the Schizophrenia International Research Society (SIRS)

Retrieved on: 
Monday, May 15, 2023

The study showed that the addition of evenamide to antipsychotics was well tolerated, with low incidence of treatment-emergent adverse events.

Key Points: 
  • The study showed that the addition of evenamide to antipsychotics was well tolerated, with low incidence of treatment-emergent adverse events.
  • 97% of patients completed six weeks of treatment, and more than 90% of the completers chose to continue with evenamide treatment into the long-term extension study (study 015).
  • Final efficacy and safety results from all 161 patients at the six-week primary endpoint of Study 014 were announced in March 2023 .
  • The multi-modal-benefits observed across various domains with evenamide also validate extensive academic research, suggesting that TRS results from excessive glutamate signalling.

EQS-News: Newron presents exciting new data from study 014/015 at CINP World Congress of Neuropsychopharmacology and the 2023 Congress of the Schizophrenia International Research Society (SIRS)

Retrieved on: 
Monday, May 15, 2023

The study showed that the addition of evenamide to antipsychotics was well tolerated, with low incidence of treatment-emergent adverse events.

Key Points: 
  • The study showed that the addition of evenamide to antipsychotics was well tolerated, with low incidence of treatment-emergent adverse events.
  • 97% of patients completed six weeks of treatment, and more than 90% of the completers chose to continue with evenamide treatment into the long-term extension study (study 015).
  • Final efficacy and safety results from all 161 patients at the six-week primary endpoint of Study 014 were announced in March 2023.
  • The multi-modal-benefits observed across various domains with evenamide also validate extensive academic research, suggesting that TRS results from excessive glutamate signalling.

ProQR Announces Initial Pipeline Targets and Highlights Axiomer® RNA Editing Platform Technology at R&D Event

Retrieved on: 
Wednesday, March 29, 2023

(Nasdaq: PRQR) (ProQR), a company dedicated to changing lives through transformative RNA therapies based on its proprietary Axiomer® RNA editing technology platform, today announced initial pipeline programs focused on diseases that originate in the liver.

Key Points: 
  • (Nasdaq: PRQR) (ProQR), a company dedicated to changing lives through transformative RNA therapies based on its proprietary Axiomer® RNA editing technology platform, today announced initial pipeline programs focused on diseases that originate in the liver.
  • ProQR will host a virtual R&D event today, during which the Company will showcase its proprietary Axiomer RNA-editing technology platform, detail the pipeline, and provide guidance on the advancement of programs toward the clinic.
  • ProQR today announced AX-0810 for Cholestatic Diseases targeting NTCP and AX-1412 for Cardiovascular Disease targeting B4GALT1 as initial pipeline programs.
  • Beyond this, ProQR has several unpublished patent applications and continuously invests in expanding its IP estate around ADAR-mediated RNA editing.

Newron Reports Compelling Topline Results From All Patients in Study 014, Its Phase II Clinical Trial Evaluating Evenamide as Add-on Therapy for Treatment-resistant Schizophrenia

Retrieved on: 
Monday, March 20, 2023

While the primary objective of the study was safety and tolerability of the drug, efficacy over baseline was also assessed.

Key Points: 
  • While the primary objective of the study was safety and tolerability of the drug, efficacy over baseline was also assessed.
  • Interim results from the first 100 patients at six weeks were previously reported in June 2022.
  • Notably, of the 161 patients who were randomized, 153 (95%) completed the six-week treatment period and 144 (94% of the completers) entered the extension study (Study 015).
  • Overall, the results from the complete study population are fully consistent with the findings from the first 100 patients at this timepoint.

EQS-News: Newron reports compelling topline results from all patients in Study 014, its Phase II clinical trial evaluating evenamide as add-on therapy for treatment-resistant schizophrenia

Retrieved on: 
Monday, March 20, 2023

Newron reports compelling topline results from all patients in Study 014, its Phase II clinical trial evaluating evenamide as add-on therapy for treatment-resistant schizophrenia

Key Points: 
  • Newron reports compelling topline results from all patients in Study 014, its Phase II clinical trial evaluating evenamide as add-on therapy for treatment-resistant schizophrenia
    The issuer is solely responsible for the content of this announcement.
  • Interim results from the first 100 patients at six weeks were previously reported in June 2022.
  • Notably, of the 161 patients who were randomized, 153 (95%) completed the six-week treatment period and 144 (94% of the completers) entered the extension study (Study 015).
  • Overall, the results from the complete study population are fully consistent with the findings from the first 100 patients at this timepoint.

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

Retrieved on: 
Thursday, September 15, 2022

We also strengthened our senior leadership team and furthered our commitments to ESG standards, principles and outcomes.

Key Points: 
  • We also strengthened our senior leadership team and furthered our commitments to ESG standards, principles and outcomes.
  • In June 2022, Newron presented key scientific data of evenamide at the 33rd Collegium Internationale Neuro-Psychopharmacologicum (CINP) Hybrid World Congress of Neuropsychopharmacology, in Taipei, Taiwan.
  • Newron sees significant progress in the enrolment of patients for study 014 and expects to complete the process by the end of 2022, with results from the study due in QI/2023.
  • Filippo joined Newron in November 2016 as IT Director and became Director of Operations in January 2022.