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Newron la rinascita

Martedi e la conferenza a new york.
non vedo l'ora, forse Weber presenetera un partner?
 
Implacabile ha scritto:
Non penso proprio, di solito a queste conferenze non viene detto nulla di importante e di nuovo.
Forse, poi, a New York nemmeno ci sarà Weber.
Clicca per espandere...
Come volevasi dimostrare, nessuna novità da NY.
Sarà marzo il mese decisivo: o le stelle, o le stalle.
 
Temo che il mese di marzo non basterà per avere i risultati della fase 008A.
Altro rinvio, altro solito ritardo, mai una volta che siano puntuali.
 
Il rapporto afferma che Newron è in trattativa con 90 parti interessate!
 
biotechinvestor ha scritto:
Il rapporto afferma che Newron è in trattativa con 90 parti interessate!
Clicca per espandere...
Si, ho letto anch'io il rapporto; certo che 90 parti interessate mi sembrano davvero troppe; se così fosse almeno una sarebbe uscita allo scoperto, puntando sul successo della fase 008A. Comunque se non otterremo dati statistici significativi, tutte e 90 spariranno nel nulla.
 
Dai, dobbiamo aspettare solo un altro mese e poi sapremo molto di più sul destino di Newron e sul nostro destino borsistico.
La lotta sarà dura, perché partiamo da una PANSS di 2, contro una PANSS di 22 di Karuna. Insomma la vedo davvero difficile superare il nostro competitor.
 
Resta da verificare se i livelli di PANSS siano importanti per l'Evenamide, in quanto add-on e non farmaco principale.
 
Chissà se gli esiti della fase 008A usciranno prima dell'assemblea del 16 aprile ?
Se fossero negativi sarà un'assemblea infuocata e Weber rischierebbe il posto di CEO.
Se fossero positivi Weber verrebbe osannato e proposto come nuovo ministro della Sanità.
 
Assemblea ordinaria con meno del 9/100 di capitale presente. Assemblea straordinaria non effettuata per mancanza quorum. Davvero poco interesse per la nostra Newron. Ancora due settimane e sapremo tutto.
 
La prossima settimana arriveranno i dati della fase 008A. Sarà una settimana epocale, nel bene o nel male.
 
Newron announces positive top-line results from potentially pivotal Phase II/III study 008A with evenamide in schizophrenia patients

Primary endpoint and key secondary endpoint of study met; drug was well tolerated, with no safety concerns identified

Glutamatergic inhibition mechanism of action offers an innovative therapeutic option to schizophrenia patients not benefitting from current antipsychotic treatments

Next step: Potentially pivotal, Phase III, one-year, randomized, double-blind, placebo-controlled trial in treatment resistant schizophrenia (TRS)

International conference call today at 3:00 PM CET/9:00 AM ET​

Milan, Italy, April 30, 2024, 07:00 am CEST – 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 (CNS), today announced positive top-line results from its potentially pivotal study 008A, evaluating the safety, tolerability and efficacy of evenamide (30 mg bid) in patients with chronic schizophrenia currently being treated with a second-generation antipsychotic including clozapine, but demonstrating an inadequate response to that treatment. The study met its primary endpoint of improvement on the Positive and Negative Syndrome Scale (PANSS) Total Score as well as the key secondary endpoint of improvement of the Clinical Global Impression of Severity (CGI-S).

Study 008A was a four-week, international, randomized, double-blind and placebo-controlled add-on Phase II/III study performed in 45 centers in 11 countries in Europe, Asia and Latin America. 291 patients were randomized to treatment either with evenamide or placebo as add-on to their current antipsychotic therapy.

Evenamide confirmed its favourable safety and tolerability profile, with a high rate of completion. Two hundred and eighty of the 291 patients completed the study with only three patients discontinuing the study due to adverse events, two of them on evenamide and one patient on placebo who died during the study. No new or specific concerns were raised in the study; only 25% of the patients in the study experienced at least one adverse event (evenamide 25% versus placebo 25.8%). There was no difference in the incidence of CNS, psychiatric, gastrointestinal or other adverse events between evenamide and placebo. The most common adverse events reported in patients treated with evenamide were headache, vomiting and nasopharyngitis (three patients, each); similar numbers of patients on placebo experienced these adverse events.

In the study, the addition of 30 mg (bid) of evenamide to the patients’ current antipsychotic medication was associated with a highly statistically significant (p-value 0.006) reduction in the PANSS Total Score of 10.2 points, compared to 7.6 points in patients treated with placebo at day 29; the least square mean difference (LS mean difference) was 2.5. For the key secondary measure, the Clinical Global Impression of Severity (CGI-S), the LS mean difference between patients treated with evenamide and placebo was 0.16; the corresponding p-value was 0.037.

Ravi Anand, MD, Chief Medical Officer of Newron, stated: “The results seen in study 008A with evenamide are ground-breaking and unique from many perspectives. This is the first major international study to demonstrate the significant benefit of adding a new chemical entity (NCE) to poorly responding, compliant schizophrenia patients being treated with a second-generation antipsychotic. It is also the first demonstration of efficacy in a placebo-controlled trial of a NCE acting exclusively through glutamatergic inhibition. These results, together with the recently reported one-year efficacy results in treatment-resistant patients, substantiate the pivotal role of glutamate in finding new therapeutic options for schizophrenia patients.”

Additional details from the study will be disclosed in the coming weeks.
 
Abbiamo quello che è forse il miglior farmaco per cura della schizofrenia, ma il prezzo dell' azione fa piangere.
 
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