Cybin Launches Strategic Clinical Site Partnerships to Support PARADIGM, a Multinational Pivotal Phase 3 Program Evaluating CYB003 for the Adjunctive Treatment of Major Depressive Disorder
Cybin Inc. (NYSE American:CYBN) has launched its first strategic partnership agreement (SPA) with Segal Trials to advance its multinational pivotal Phase 3 program evaluating CYB003 for Major Depressive Disorder (MDD) treatment. The program aims to enroll approximately 550 patients across 40+ clinical sites in the US and Europe.
Segal Trials, operating six research sites in South Florida, brings extensive experience in psychiatry, neurology, addiction, and psychedelics research. The partnership strategy aims to enhance trial operations efficiency and site performance through collaboration.
Recent Phase 2 data showed remarkable results, with 71% of patients achieving remission from depression symptoms for 12 months after receiving two 16mg doses of CYB003 administered three weeks apart.
Cybin Inc. (NYSE American:CYBN) ha avviato il suo primo accordo di partnership strategica (SPA) con Segal Trials per avanzare il suo programma multinazionale di Fase 3 che valuta CYB003 per il trattamento del Disturbo Depressivo Maggiore (MDD). Il programma si propone di arruolare circa 550 pazienti in oltre 40 siti clinici negli Stati Uniti e in Europa.
Segal Trials, che gestisce sei centri di ricerca nel Sud della Florida, porta con sé una vasta esperienza nella psichiatria, neurologia, dipendenza e ricerca sui psichedelici. La strategia della partnership mira a migliorare l'efficienza delle operazioni degli studi clinici e le performance dei siti tramite collaborazione.
I recenti dati della Fase 2 hanno mostrato risultati notevoli, con il 71% dei pazienti che ha raggiunto la remissione dai sintomi depressivi per 12 mesi dopo aver ricevuto due dosi da 16mg di CYB003 somministrate a tre settimane di distanza.
Cybin Inc. (NYSE American:CYBN) ha lanzado su primer acuerdo de asociación estratégica (SPA) con Segal Trials para avanzar en su programa multinacional de Fase 3 que evalúa CYB003 para el tratamiento del Trastorno Depresivo Mayor (MDD). El programa tiene como objetivo reclutar aproximadamente 550 pacientes en más de 40 sitios clínicos en EE. UU. y Europa.
Segal Trials, que opera seis sitios de investigación en el sur de Florida, aporta una amplia experiencia en psiquiatría, neurología, adicciones e investigación psicodélica. La estrategia de la asociación busca mejorar la eficiencia de las operaciones de los ensayos y el rendimiento de los sitios a través de la colaboración.
Los recientes datos de la Fase 2 mostraron resultados notables, con el 71% de los pacientes alcanzando remisión de los síntomas depresivos durante 12 meses después de recibir dos dosis de 16mg de CYB003 administradas con tres semanas de diferencia.
Cybin Inc. (NYSE American:CYBN)는 주요 우울 장애 (MDD) 치료를 위한 CYB003을 평가하는 다국적 3상 프로그램을 발전시키기 위해 Segal Trials와 첫 번째 전략적 파트너십 계약 (SPA)을 체결했습니다. 이 프로그램은 미국과 유럽의 40개 이상의 임상 사이트에서 약 550명의 환자를 등록하는 것을 목표로 하고 있습니다.
Segal Trials는 남부 플로리다에서 6개의 연구 센터를 운영하며, 정신과, 신경학, 중독 및 환각제 연구에서 광범위한 경험을 보유하고 있습니다. 파트너십 전략은 협력을 통해 시험 운영의 효율성과 사이트 성과를 높이기 위한 것입니다.
최근의 2상 데이터는 주목할 만한 결과를 보여주었으며, 71%의 환자가 우울증 증상에서 12개월 동안 완화 상태에 도달했습니다. 이는 16mg의 CYB003을 두 차례에 걸쳐 세 주 간격으로 투여한 결과입니다.
Cybin Inc. (NYSE American:CYBN) a lancé son premier accord de partenariat stratégique (SPA) avec Segal Trials pour faire avancer son programme multinational de Phase 3 évaluant CYB003 pour le traitement du Trouble Dépressif Majeur (MDD). Le programme vise à recruter environ 550 patients sur plus de 40 sites cliniques aux États-Unis et en Europe.
Segal Trials, qui opère six sites de recherche dans le sud de la Floride, apporte une vaste expérience dans les domaines de la psychiatrie, de la neurologie, de la dépendance et de la recherche psychédélique. La stratégie de partenariat vise à optimiser l'efficacité des opérations d'essai et le rendement des sites grâce à la collaboration.
Les données récentes de la Phase 2 ont montré des résultats remarquables, avec 71 % des patients atteignant la rémission des symptômes dépressifs pendant 12 mois après avoir reçu deux doses de 16 mg de CYB003 administrées à trois semaines d'intervalle.
Cybin Inc. (NYSE American:CYBN) hat seine erste strategische Partnerschaftsvereinbarung (SPA) mit Segal Trials gestartet, um sein multinationales, entscheidendes Phase 3-Programm zur Evaluierung von CYB003 zur Behandlung von Major Depressive Disorder (MDD) voranzubringen. Das Programm zielt darauf ab, etwa 550 Patienten an über 40 klinischen Standorten in den USA und Europa einzuschließen.
Segal Trials, das sechs Forschungsstandorte in Südflorida betreibt, bringt umfassende Erfahrung in Psychiatrie, Neurologie, Sucht und psychodelischer Forschung mit. Die Partnerschaftsstrategie zielt darauf ab, die Effizienz der Studienoperationen und die Leistung der Standorte durch Zusammenarbeit zu verbessern.
Die aktuellen Phase 2-Daten zeigten bemerkenswerte Ergebnisse, wobei 71 % der Patienten eine Remission der depressiven Symptome für 12 Monate nach Empfang von zwei 16mg Dosen von CYB003, die drei Wochen auseinander verabreicht wurden, erzielten.
- Phase 2 trial showed 71% remission rate in depression symptoms lasting 12 months
- Strategic partnership with Segal Trials to accelerate Phase 3 trial execution
- Large-scale Phase 3 trial planned with 550 patients across 40+ sites
- Geographic expansion into US and European markets
- Significant resources required for large-scale Phase 3 trial across multiple countries
- Extended timeline needed for multinational trial completion
Insights
The Phase 3 trial initiation for CYB003 represents a critical milestone in psychedelic medicine development. The 71% remission rate observed in Phase 2 with just two doses over 12 months is remarkable compared to conventional antidepressants, which typically require daily dosing and achieve remission rates of only 30-40%.
The strategic partnership with Segal Trials is particularly noteworthy as it brings expertise in psychiatry and psychedelics research across six sites. This multi-site approach with planned 550 patients across 40+ clinical sites in the US and Europe provides the robust sample size needed for FDA approval. The standardization of protocols across sites through these partnerships will be important for data quality and regulatory compliance.
For investors, this development indicates strong execution of Cybin's clinical program. The company is taking a methodical approach to site selection and trial management, which is essential given the complexity of psychedelic drug trials. The focus on long-term partnerships suggests potential cost efficiencies and accelerated timeline for future pipeline developments.
This announcement positions Cybin at the forefront of the emerging psychedelic medicine market, estimated to reach
The impressive Phase 2 results showing 12-month remission with just two doses could revolutionize the
The scalable partnership model suggests potential for faster recruitment and trial completion, which could accelerate time-to-market and reduce development costs - critical factors for a company with a
- Strategic Partnership Agreements will facilitate collaboration among sites, cultivate long term partnerships, enhance efficiency in trial operations, and improve overall site performance -
- First program member is Segal Trials, a preferred provider for leading pharmaceutical companies globally -
- Phase 2 data confirmed that two 16 mg doses of CYB003 administered three weeks apart provides remission from depression symptoms for 12 months in
Segal Trials, the first program member, is a privately held company with a network of six research sites throughout
“Following the release of our remarkable Phase 2 data, which demonstrated that two 16-mg doses of CYB003 administered three weeks apart provided remission from depression symptoms for 12 months for the majority of patients, we are excited that our Phase 3 multinational pivotal program is underway,” said Doug Drysdale, Chief Executive Officer of Cybin. “We intend to enroll approximately 550 patients across more than 40 clinical sites in
“We are thrilled to collaborate with Cybin on its innovative Site Partnership Program. This partnership will accelerate learning at new sites around the country, enabling more research and could ultimately expedite the approval process for CYB003,” said Bonnie Segal, President of Segal Trials.
About Cybin
Cybin is a late-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options to address the large unmet need for people who suffer from mental health conditions.
With industry leading proof-of-concept data, Cybin is working to change the mental health treatment landscape through the introduction of intermittent treatments that provide long lasting results. The Company is currently developing CYB003, a proprietary deuterated psilocin program, in Phase 3 development for the adjunctive treatment of major depressive disorder and CYB004, a proprietary deuterated N, N-dimethyltryptamine program in a Phase 2 study for generalized anxiety disorder. The company also has a research pipeline of investigational, 5-HT-receptor focused compounds.
Founded in 2019, Cybin is operational in
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Investor & Media Contact:
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1-866-292-4601
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Source: Cybin Inc.
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