Neurocrine Biosciences to Present New Data from Phase 2 Study of Osavampator in Adults with Major Depressive Disorder at 38th Annual Psych Congress 2025
Neurocrine Biosciences (Nasdaq: NBIX) will present new data from its Phase 2 SAVITRI study of osavampator at Psych Congress 2025. The study investigates osavampator as an adjunctive treatment for adults with major depressive disorder (MDD) who have inadequate response to oral antidepressants.
Following positive top-line results, the company initiated a Phase 3 registrational program in January 2025, comprising five active enrolling studies. The company will present multiple posters, with two selected as finalists for Psych Congress Poster Awards, focusing on osavampator's clinical improvements in depression severity and its mechanism as a selective AMPA-PAM.
Neurocrine Biosciences (Nasdaq: NBIX) presenterà nuovi dati dallo studio di fase 2 SAVITRI su osavampator al Psych Congress 2025. Lo studio esamina osavampator come trattamento aggiuntivo per adulti con disturbo depressivo maggiore (MDD) che non hanno reagito in modo adeguato agli antidepressivi orali.
Dopo i risultati positivi di livello iniziale, la società ha avviato nel gennaio 2025 un programma registrazionale di fase 3, composto da cinque studi attivi in arruolamento. L'azienda presenterà diversi poster, di cui due selezionati come finalisti per i Psych Congress Poster Awards, concentrandosi sui miglioramenti clinici della gravità della depressione e sul meccanismo di osavampator come AMPA-PAM selettivo.
Neurocrine Biosciences (Nasdaq: NBIX) presentará nuevos datos del estudio de fase 2 SAVITRI sobre osavampator en Psych Congress 2025. El estudio investiga osavampator como tratamiento adjunto para adultos con trastorno depresivo mayor (MDD) que no han respondido adecuadamente a los antidepresivos orales.
Después de resultados positivos de los indicadores principales, la compañía inició en enero de 2025 un programa registracional de fase 3, con cinco estudios activos en reclutamiento. La empresa presentará varios pósteres, dos de los cuales fueron seleccionados como finalistas para los Premios de Pósters de Psych Congress, centrados en las mejoras clínicas de la gravedad de la depresión y en su mecanismo como AMPA-PAM selectivo.
Neurocrine Biosciences (Nasdaq: NBIX)가 osavampator에 대한 Phase 2 SAVITRI 연구의 새로운 데이터를 Psych Congress 2025에서 발표합니다. 이 연구는 구강 항우울제에 반응이 불충분한 성인 Major Depressive Disorder(MDD) 환자에서 보조 치료제로서의 osavampator를 조사합니다.
양성 결과에 따라 회사는 2025년 1월에 Phase 3 등록 프로그램을 시작했으며, 다섯 개의 활발히 등록 중인 연구로 구성되어 있습니다. 회사는 여러 포스터를 발표할 것이며, Psych Congress Poster Awards의 결선 진출자 두 편으로 선정된 포스터를 포함해 우울증 중증도 개선 및 선택적 AMPA-PAM으로서의 기전에 초점을 맞춥니다.
Neurocrine Biosciences (Nasdaq: NBIX) présentera de nouvelles données de son étude de phase 2 SAVITRI sur l’osavampator lors du Psych Congress 2025. L’étude évalue l’osavampator comme traitement d’appoint chez des adultes souffrant de trouble dépressif majeur (TDM) qui n’ont pas répondu de manière adéquate aux antidépresseurs oraux.
Suite à des résultats positifs en ligne principale, la société a démarré en janvier 2025 un programme d’enregistrement de phase 3, comprenant cinq études en recrutement actif. L’entreprise présentera plusieurs posters, dont deux seront sélectionnés comme finalistes pour les Psych Congress Poster Awards, en mettant l’accent sur les améliorations cliniques de la sévérité de la dépression et sur le mécanisme de l’osavampator en tant que PAM AMPA sélectif.
Neurocrine Biosciences (Nasdaq: NBIX) wird beim Psych Congress 2025 neue Daten aus der Phase-2-SAVITRI-Studie zu Osavampator präsentieren. Die Studie untersucht Osavampator als Zusatztherapie bei Erwachsenen mit Major Depression Disorder (MDD), die auf orale Antidepressiva unzureichend reagiert haben.
Nach positiven Topline-Ergebnissen hat das Unternehmen im Januar 2025 ein Phase-3-registrational Programm gestartet, das fünf aktiv eingeschriebene Studien umfasst. Das Unternehmen wird mehrere Poster präsentieren, von denen zwei als Finalisten für die Psych Congress Poster Awards ausgewählt wurden, mit Fokus auf klinische Verbesserungen der Depressions-Schwere und dem Mechanismus von Osavampator als selektiver AMPA-PAM.
Neurocrine Biosciences (Nasdaq: NBIX) ستعرض بيانات جديدة من دراسة المرحلة 2 SAVITRI عن أوسافامباتور في Psych Congress 2025. الدراسة تبحث في أوسافامباتور كعلاج مساعد للبالغين المصابين باضطراب اكتئابي رئيسي (MDD) الذين لم يستجيبوا بشكل كافٍ لمضادات الاكتئاب الفموية.
عقب نتائج إيجابية أولية، بدأت الشركة في يناير 2025 برنامجاً تسجيلياً من المرحلة 3، يشتمل على خمس دراسات نشطة في التجنيد. ستعرض الشركة عدة ملصقات، اختير اثنان منها كنهائيين لجائزة Psych Congress Poster Awards، وتتركز على التحسينات السريرية في شدة الاكتئاب وعلى آلية عمل أوسافامباتور كـ AMPA-PAM انتقائي.
Neurocrine Biosciences (纳斯达克: NBIX) 将在 Psych Congress 2025 上展示其 Phase 2 SAVITRI 研究中 osavampator 的新数据。该研究将 osavampator 作为辅助治疗用于对口服抗抑郁药反应不足的成人重度抑郁障碍（MDD）患者。
在初步阳性结果之后，该公司于 2025 年 1 月启动了 Phase 3 注册性计划，包含五项正在招募的研究。公司将展示多份海报，其中两份被选为 Psych Congress 海报奖决赛入围者，重点介绍 osavampator 在抑郁严重程度方面的临床改善及其作为选择性 AMPA-PAM 的作用机制。
- Phase 2 SAVITRI study demonstrated statistically significant and clinically meaningful improvements in depression severity
- Two posters selected as finalists for Psych Congress Poster Awards, indicating scientific recognition
- Phase 3 registrational program already initiated and actively enrolling in five studies
- Osavampator shows potential as a first-in-class treatment for MDD
- None.
Insights
Neurocrine's osavampator showing strong Phase 2 results, Phase 3 trials underway for potentially first-in-class MDD treatment.
The expanded data presentation from Neurocrine's Phase 2 SAVITRI study represents a significant milestone in the company's clinical development program for osavampator. As a selective AMPA-PAM (positive allosteric modulator of the AMPA receptor), this compound employs a novel mechanism of action for treating major depressive disorder (MDD), potentially offering a first-in-class option for patients inadequately responsive to conventional antidepressants.
The confidence displayed by initiating a comprehensive Phase 3 program with five active trials suggests the Phase 2 data was compelling enough to warrant substantial investment in late-stage development. The nomination of their poster as a finalist for the Psych Congress Poster Awards further validates the scientific community's interest in these findings.
The AMPA receptor modulation approach represents a departure from traditional monoamine-based antidepressants (SSRIs, SNRIs), potentially offering a more rapid onset of action similar to ketamine but with a potentially improved safety profile. If successful in Phase 3, osavampator could address a significant unmet need among the approximately
The company's advancement to Phase 3 just months after reporting positive top-line data indicates internal confidence in both the efficacy signals and safety profile observed thus far. The clinical development timeline appears to be progressing efficiently, with the potential for regulatory submission within the next 2-3 years pending Phase 3 success.
- Additional Data from SAVITRI™ Study Expand on Top-Line Results Announced in April 2024
- SAVITRI Poster Presentation Chosen as Finalist for Psych Congress Poster Awards
Osavampator (NBI-1065845) is an investigational selective positive allosteric modulator of the alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid receptor (AMPA-PAM) in development as a potential adjunctive treatment for adults with major depressive disorder (MDD) who have an inadequate response to oral antidepressant treatment.
"The expanded data we will share at Psych Congress from our Phase 2 SAVITRI study represent an important step forward in understanding and addressing major depressive disorder," said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. "We are confident in our osavampator program and its potential to be a first-in-class treatment."
Following the announcement of positive top-line data from the Phase 2 SAVITRI study, Neurocrine initiated a Phase 3 registrational program of osavampator in January 2025, which includes five studies that are currently active and enrolling. For more information about the Phase 3 osavampator studies, please visit: ClinicalTrials.gov.
Neurocrine will present the following posters at Psych Congress, which will be displayed on Friday, September 19 from 1:30 pm – 3:00 pm PT and 6:00 pm – 7:15 pm PT and on Saturday, September 20 from 1:30 pm – 3:00 pm PT:
- Osavampator (NBI-1065845/TAK-653) Demonstrates Statistically Significant and Clinically Meaningful Improvements in Depression Severity and is Well Tolerated in Adults with Major Depressive Disorder: Phase 2 SAVITRI Results (Poster #33)
- Finalist for Psych Congress Poster Awards. Nominated Posters on Display Saturday, September 20 from 6:00 pm – 7:15 pm PT.
- Osavampator: A Selective Positive Allosteric Modulator of the AMPA Receptor (AMPA-PAM) in Development for the Treatment of Major Depressive Disorder (Poster #34)
- The Functional Impact of Major Depressive Disorder on Patients' Daily Lives: A Qualitative Investigation of Patient and Clinician Perspectives (Poster #20)
- Finalist for Psych Congress Poster Awards. Nominated Posters on Display Saturday, September 20 from 6:00 pm – 7:15 pm PT.
- Once-Daily Valbenazine Improves the Impacts and Symptoms of Tardive Dyskinesia Regardless of Psychiatric Diagnosis: Results from the Phase 4 KINECT-PRO™ Study (Poster #152)
- Once-Daily Valbenazine Improves the Impacts of Tardive Dyskinesia (TD) in Patients Who Met a Threshold for TD Remission: Post Hoc Analyses of Patient-Reported Outcomes from KINECT-PRO (Poster #158)
- Valbenazine Improves Physical, Social, and Emotional Impacts on the Tardive Dyskinesia Impact Scale (TDIS™): Post Hoc Analyses of KINECT-PRO Data (Poster #160)
- Estimation of the Minimal Clinically Important Difference (MCID) and Longitudinal Change in the Tardive Dyskinesia Impact Scale (TDIS), a Validated, Tardive Dyskinesia-Specific, Patient-Reported Outcome Measure (Poster #98)
- Physical, Mental, and Socioemotional Functional Improvement Following Valbenazine Treatment for Tardive Dyskinesia: a Case Series (Poster #84)
- Once-Daily Valbenazine for the Treatment of Tardive Dyskinesia in Elderly Adults and Other Special Populations (Poster #186)
- Valbenazine Improves Tardive Dyskinesia in Patients Regardless of Ethnicity or Race: Post Hoc Analyses of Long-Term Data from the KINECT® 4 Study (Poster #150)
- A Qualitative, Interview-based Study of Patient, Caregiver, and Prescriber Rankings of Functional Outcome Improvements in Schizophrenia (Poster #108)
About Osavampator and the Phase 2 SAVITRI Study
Osavampator (NBI-1065845) is an investigational potential first-in-class selective positive allosteric modulator of the alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid receptor (AMPA-PAM) in development as a potential adjunctive treatment for adults with major depressive disorder (MDD) who have an inadequate response to oral antidepressant treatment. Neurocrine received an exclusive license to osavampator from Takeda Pharmaceutical Company Limited for all indications in all territories worldwide except
The Phase 2 SAVITRI study was a double-blind, placebo-controlled study designed to assess the efficacy and safety of investigational osavampator in adult subjects with MDD. The study enrolled 183 adults with a primary diagnosis of MDD who had an inadequate response to current antidepressant treatment.
About Major Depressive Disorder
Major depressive disorder is a serious disorder characterized by a persistently depressed mood, loss of interest, poor concentration, and decreased energy, among other symptoms. According to the World Health Organization, MDD is one of the leading causes of disability, is a serious condition that presents an increased risk of suicide and self-harm and is associated with increased all-cause mortality. More than 21 million people in the
About Neurocrine Biosciences, Inc.
Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. (*in collaboration with AbbVie)
The NEUROCRINE BIOSCIENCES Logo, NEUROCRINE, YOU DESERVE BRAVE SCIENCE, INGREZZA and KINECT are registered trademarks of Neurocrine Biosciences, Inc. SAVITRI, TDIS and KINECT-PRO are trademarks of Neurocrine Biosciences, Inc.
Forward-Looking Statements
In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding the clinical results from, and our future development plans with respect to, osavampator (NBI-1065845), the therapeutic potential and clinical benefits or safety profile of osavampator, and the potential benefits to be derived from certain of our products. Factors that could cause actual results to differ materially from those stated or implied in the forward-looking statements include, but are not limited to, the following: data that we report may change following a more comprehensive review of the data related to the clinical study and such data may not accurately reflect the complete results of the clinical study; risks that clinical development activities may not be initiated or completed on time or at all, or may be delayed for regulatory, manufacturing or other reasons, may not be successful or replicate previous clinical trial results, may fail to demonstrate that our product candidates are safe and effective, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that regulatory submissions for our product candidates may not occur or be submitted in a timely manner; our future financial and operating performance; risks associated with our dependence on third parties for development, manufacturing and commercialization activities for our products and product candidates and our ability to manage these third parties; risks that the FDA or other regulatory authorities may make adverse decisions regarding our products or product candidates; risks that the potential benefits of the agreements with our collaboration partners may never be realized; risks that our products and/or our product candidates may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks associated with
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