Neurocrine Biosciences Announces Initiation of Phase 3 Registrational Program for Osavampator as an Adjunctive Therapy for the Treatment of Major Depressive Disorder in Adults
Neurocrine Biosciences (NBIX) has initiated a Phase 3 registrational study for osavampator, a potential first-in-class adjunctive treatment for major depressive disorder (MDD). This announcement follows positive topline data from the Phase 2 SAVITRI™ study reported in April 2024, where the drug met its primary and secondary endpoints and showed good tolerability.
The drug aims to address a significant unmet need, as MDD affects over 21 million people in the United States, with more than one-third of patients experiencing debilitating symptoms that current treatments cannot fully address. The Phase 3 study will evaluate the drug's efficacy, safety, and tolerability as an adjunctive therapy to antidepressants.
Neurocrine Biosciences (NBIX) ha avviato uno studio registrativo di Fase 3 per osavampator, un potenziale trattamento adiuvante di prima classe per il disturbo depressivo maggiore (MDD). Questo annuncio segue i positivi dati preliminari dello studio di Fase 2 SAVITRI™ riportati ad aprile 2024, dove il farmaco ha raggiunto i suoi obiettivi primari e secondari, mostrando una buona tollerabilità.
Il farmaco mira a rispondere a un'importante esigenza insoddisfatta, poiché il MDD colpisce oltre 21 milioni di persone negli Stati Uniti, con più di un terzo dei pazienti che sperimenta sintomi debilitanti che i trattamenti attuali non riescono a gestire completamente. Lo studio di Fase 3 valuterà l'efficacia, la sicurezza e la tollerabilità del farmaco come terapia adiuvante agli antidepressivi.
Neurocrine Biosciences (NBIX) ha iniciado un estudio de registro de fase 3 para osavampator, un posible tratamiento adyuvante de primera clase para el trastorno depresivo mayor (MDD). Este anuncio sigue a los positivos datos preliminares del estudio de fase 2 SAVITRI™, reportados en abril de 2024, donde el fármaco cumplió con sus objetivos primarios y secundarios y mostró buena tolerancia.
El fármaco tiene como objetivo abordar una necesidad importante no satisfecha, ya que el MDD afecta a más de 21 millones de personas en los Estados Unidos, con más de un tercio de los pacientes experimentando síntomas debilitantes que los tratamientos actuales no pueden abordar completamente. El estudio de fase 3 evaluará la eficacia, la seguridad y la tolerabilidad del fármaco como terapia adyuvante a los antidepresivos.
Neurocrine Biosciences (NBIX)는 주요 우울 장애(MDD)에 대한 잠재적인 최초의 보조 치료제인 osavampator의 3상 등록 연구를 시작했습니다. 이 발표는 2024년 4월에 보고된 2상 SAVITRI™ 연구의 긍정적인 주요 데이터를 따른 것으로, 이 연구에서 약물은 주요 및 부차적인 목표를 달성하고 좋은 내약성을 보여주었습니다.
이 약물은 MDD로 고통받는 미국에서 2100만 명 이상의 사람들에게 중요한 충족되지 않은 필요를 해결하고자 합니다. 현재의 치료가 완전히 해결할 수 없는 심각한 증상을 경험하는 환자가 3분의 1 이상입니다. 3상 연구에서는 항우울제에 대한 보조 치료로서의 약물의 효과, 안전성 및 내약성을 평가할 것입니다.
Neurocrine Biosciences (NBIX) a lancé une étude de phase 3 pour l'osavampator, un traitement adjoint potentiel de première classe pour le trouble dépressif majeur (MDD). Cette annonce fait suite à des données préliminaires positives de l'étude SAVITRI™ de phase 2, rapportées en avril 2024, où le médicament a atteint ses objectifs primaires et secondaires et a montré une bonne tolérabilité.
Le médicament vise à répondre à un besoin non satisfait important, car le MDD touche plus de 21 millions de personnes aux États-Unis, avec plus d'un tiers des patients souffrant de symptômes débilitants que les traitements actuels ne peuvent pas complètement traiter. L'étude de phase 3 évaluera l'efficacité, la sécurité et la tolérabilité du médicament en tant que thérapie adjointe aux antidépresseurs.
Neurocrine Biosciences (NBIX) hat eine registrierende Studie der Phase 3 für osavampator gestartet, eine potenzielle erstklassige Ergänzungsbehandlung für die Major Depression (MDD). Diese Ankündigung folgt auf positive vorläufige Daten aus der Phase 2 SAVITRI™-Studie, die im April 2024 veröffentlicht wurden, in der das Medikament seine primären und sekundären Endpunkte erreichte und eine gute Verträglichkeit zeigte.
Das Medikament zielt darauf ab, einem erheblichen ungedeckten Bedarf zu begegnen, da MDD mehr als 21 Millionen Menschen in den Vereinigten Staaten betrifft, wobei mehr als ein Drittel der Patienten unter belastenden Symptomen leidet, die von den aktuellen Behandlungen nicht vollständig adressiert werden können. Die Phase-3-Studie wird die Wirksamkeit, Sicherheit und Verträglichkeit des Medikaments als ergänzende Therapie zu Antidepressiva bewerten.
- Phase 2 SAVITRI study met both primary and secondary endpoints
- Drug demonstrated good tolerability in Phase 2 trials
- Potential to be first-in-class treatment for MDD
- Addresses large market opportunity with 21 million affected patients in US
- None.
Insights
The initiation of Phase 3 trials for osavampator marks a important inflection point for Neurocrine Biosciences in the $15+ billion major depressive disorder (MDD) market. The drug's progression follows successful Phase 2 SAVITRI study results, positioning it as a potential first-in-class adjunctive therapy in a market desperate for innovation.
The addressable market is substantial and largely untapped. With over 21 million MDD patients in the US and approximately one-third showing inadequate response to current treatments, the commercial opportunity could exceed
The timing is especially favorable given the current options for treatment-resistant depression. Major pharmaceutical companies have largely scaled back their CNS research programs, creating a significant opportunity for specialized players like Neurocrine. The company's expertise in neurological disorders and established commercial infrastructure could provide significant advantages in market penetration.
For investors, three key aspects warrant attention: 1) The Phase 3 program's design and timeline, which will likely require multiple studies and take 2-3 years to complete, 2) The potential for priority review given the unmet medical need and 3) The implications for Neurocrine's revenue diversification strategy beyond its current portfolio.
"Osavampator has the potential to become a first-in-class treatment for MDD, a disorder that impacts more than 21 million people in
The Phase 2 SAVITRI study with osavampator met its primary and secondary endpoints, and was generally well tolerated.
"Major depressive disorder is a condition that has a profound effect on patients and their families and is associated with significant morbidity and mortality," said Maurizio Fava, M.D., Chair, Mass General Brigham Academic Medical Centers Department of Psychiatry. "The great majority of patients suffering from major depressive disorder do not achieve a sustained remission of their condition and the options for next step strategies to help them are quite limited. This trial is happening at a time when it is clear that, as a field, we need to develop new augmentation strategies to enhance the efficacy of standard antidepressants."
About Osavampator and the Phase 3 Registrational Program
Osavampator (formerly NBI-1065845) is a potential first-in-class, investigational alpha-amino-3-hydroxy-5-methyl-4-isoxazole propionic acid (AMPA) positive allosteric modulator (PAM) in development as a potential treatment for patients with inadequate response to treatment in MDD. Neurocrine received an exclusive license to osavampator from Takeda Pharmaceutical Company Limited for all indications in all territories worldwide except
The Phase 3 registrational program is designed to assess the efficacy, safety and tolerability of osavampator in adult subjects with MDD. The study will enroll adults with a primary diagnosis of MDD, who have inadequate response to current antidepressant treatment. For more information about the Phase 3 osavampator study, click here.
About Major Depressive Disorder
Major depressive disorder (MDD) 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 rates. More than 21 million people in the
About Neurocrine Biosciences
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 (formerly Twitter), and Facebook.
(*in collaboration with AbbVie)
The NEUROCRINE BIOSCIENCES Logo Lockup and YOU DESERVE BRAVE SCIENCE are registered trademarks of Neurocrine Biosciences, Inc. SAVITRI is a trademark 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 safety, efficacy, and therapeutic potential of NBI-1065845; and the results, conduct, and timing of our NBI-1065845 Phase 3 clinical study. 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: 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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SOURCE Neurocrine Biosciences, Inc.
FAQ
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