Cybin Announces Poster Presentations at the 2024 American College of Neuropsychopharmacology Annual Meeting, Including CYB003 12-Month Efficacy Results
Cybin announced two poster presentations at the 2024 American College of Neuropsychopharmacology Annual Meeting, showcasing significant clinical data from their mental health treatment programs. The first presentation highlights 12-month efficacy results from their Phase 2 study of CYB003 (deuterated psilocin) in Major Depressive Disorder, demonstrating 100% response rate and 71% remission rate with two 16mg doses.
The second presentation focuses on a Phase 1b study examining drug interactions between DMT and SSRIs in MDD patients, suggesting patients may not need to stop antidepressant treatment before psychedelic therapy. The company also noted progress in their CYB004 deuterated DMT program, currently in Phase 2 trials for Generalized Anxiety Disorder.
Cybin ha annunciato due presentazioni di poster al Meeting Annuale del Collegio Americano di Neuropsicofarmacologia 2024, mostrando dati clinici significativi dai loro programmi di trattamento per la salute mentale. La prima presentazione evidenzia i risultati di efficacia a 12 mesi del loro studio di Fase 2 su CYB003 (psilocina deuterata) nel Disturbo Depressivo Maggiore, dimostrando un tasso di risposta del 100% e un tasso di remissione del 71% con due dosi da 16 mg.
La seconda presentazione si concentra su uno studio di Fase 1b che esamina le interazioni tra DMT e SSRI nei pazienti con DDM, suggerendo che i pazienti potrebbero non dover interrompere il trattamento antidepressivo prima della terapia psichedelica. L'azienda ha anche notato progressi nel loro programma CYB004 DMT deuterato, attualmente in trials di Fase 2 per il Disturbo d'Ansia Generalizzato.
Cybin anunció dos presentaciones de carteles en la Reunión Anual de la Academia Americana de Neuropsicofarmacología 2024, mostrando datos clínicos significativos de sus programas de tratamiento de salud mental. La primera presentación destaca los resultados de eficacia a 12 meses de su estudio de Fase 2 sobre CYB003 (psilocina deuterada) en el Trastorno Depresivo Mayor, demostrando una tasa de respuesta del 100% y una tasa de remisión del 71% con dos dosis de 16 mg.
La segunda presentación se centra en un estudio de Fase 1b que examina las interacciones entre DMT y SSRIs en pacientes con TDM, sugiriendo que los pacientes pueden no necesitar interrumpir el tratamiento con antidepresivos antes de la terapia psicodélica. La empresa también señaló avances en su programa CYB004 DMT deuterado, que actualmente está en ensayos de Fase 2 para el Trastorno de Ansiedad Generalizada.
Cybin은 2024년 미국 신경심리약리학 연례 회의에서 두 개의 포스터 발표를 진행하며 정신 건강 치료 프로그램의 중요한 임상 데이터를 선보였습니다. 첫 번째 발표는 주요 우울 장애에서의 CYB003(중수소 파실로신) 2상 연구의 12개월 효능 결과를 강조하며, 두 개의 16mg 투여에서 100%의 반응률과 71%의 자가 보고를 높였습니다.
두 번째 발표는 MDD 환자에서 DMT와 SSRI 간의 약물 상호작용을 조사한 1b상 연구에 초점을 맞추고 있으며, 환자들이 환각 요법을 받기 전에 항우울제 치료를 중단할 필요가 없을 수 있음을 제안합니다. 회사는 또한 일반화된 불안 장애에 대한 2상 시험 중인 CYB004 중수소 DMT 프로그램의 진행 상황을 주목했습니다.
Cybin a annoncé deux présentations d'affiches lors de la Réunion Annuelle du Collège Américain de Neuropsychopharmacologie 2024, mettant en avant des données cliniques significatives issues de ses programmes de traitement de la santé mentale. La première présentation met en lumière les résultats d'efficacité de 12 mois de son étude de Phase 2 sur le CYB003 (psilocine déuterée) dans le trouble dépressif majeur, démontrant un taux de réponse de 100 % et un taux de rémission de 71 % avec deux doses de 16 mg.
La seconde présentation se concentre sur une étude de Phase 1b examinant les interactions médicamenteuses entre le DMT et les ISRS chez les patients atteints de TDM, suggérant que les patients pourraient ne pas avoir besoin d'arrêter leur traitement antidépresseur avant la thérapie psychédélique. L'entreprise a également signalé des progrès dans son programme CYB004 DMT déuteré, actuellement en essais de Phase 2 pour le trouble de l'anxiété généralisée.
Cybin kündigte zwei Posterpräsentationen beim 2024 American College of Neuropsychopharmacology Annual Meeting an, die bedeutende klinische Daten aus ihren Psychiatrie-Behandlungsprogrammen präsentieren. Die erste Präsentation hebt die 12-monatigen Wirksamkeitsergebnisse aus ihrer Phase-2-Studie zu CYB003 (deuterierte Psilocin) bei Major Depressive Disorder hervor und zeigt eine 100%ige Ansprechraten und eine 71%ige Remissionsrate bei zwei 16mg Dosen.
Die zweite Präsentation konzentriert sich auf eine Phase-1b-Studie, die Arzneimittelinteraktionen zwischen DMT und SSRIs bei MDD-Patienten untersucht und nahelegt, dass Patienten möglicherweise keine Antidepressivumbehandlung vor einer psychedelischen Therapie unterbrechen müssen. Das Unternehmen wies auch auf Fortschritte in ihrem CYB004 deuterierten DMT-Programm hin, das sich derzeit in Phase-2-Studien für Generalisierte Angststörung befindet.
- Phase 2 study showed 100% response rate and 71% remission rate at 12 months with CYB003
- Positive drug interaction study results showing compatibility between DMT and SSRIs
- Advancement to Phase 3 PARADIGM program for CYB003 in MDD treatment
- Potential enhanced efficacy when SPL026 is administered with SSRIs
- None.
Insights
The 12-month efficacy data from CYB003's Phase 2 study demonstrates remarkable durability in treating Major Depressive Disorder, with 100% response rate and 71% remission rate after two 16mg doses. These results are particularly significant given that conventional antidepressants typically require daily dosing and often show lower efficacy rates.
The drug-drug interaction study between DMT and SSRIs reveals a important advantage - patients won't need to discontinue their current antidepressant treatment to receive psychedelic therapy. This could significantly reduce treatment barriers and potentially enhance therapeutic outcomes through synergistic effects.
The advancement to Phase 3 PARADIGM trials indicates strong clinical confidence in CYB003's potential. With 21 million Americans affected by MDD and roughly two-thirds showing resistance to traditional treatments, these results suggest a potentially paradigm-shifting approach to depression treatment.
The positive clinical data strengthens Cybin's competitive position in the psychedelic therapeutics space. The company's dual-track approach with both psilocin (CYB003) and DMT (CYB004) programs diversifies their pipeline and increases chances of commercial success. The compatibility with SSRIs is particularly valuable from a market perspective, as it significantly expands the potential patient pool and simplifies treatment protocols.
The progression to Phase 3 trials for CYB003 marks a critical milestone that could accelerate the path to commercialization. With a market cap of
- Poster presentations highlight clinical data across Cybin’s CYB003 deuterated psilocin and DMT programs -
The data presented include 12-month efficacy results from the Company’s Phase 2 study of CYB003, its deuterated psilocin program, in Major Depressive Disorder (“MDD”), which showed durable response and remission rates at 12 months, in addition to results from a completed Phase 1b study exploring drug-drug interactions between N,N-dimethyltryptamine (“DMT”) and selective serotonin reuptake inhibitors (“SSRIs”), in MDD patients.
“The ACNP annual meeting is an excellent opportunity to share the rapid clinical progress Cybin is making across our deuterated psilocin and DMT programs,” said Doug Drysdale, Chief Executive Officer of Cybin. “MDD affects roughly 21 million people in the
“The sustained improvement in symptoms of depression at the 12-month mark after just two doses of CYB003 is truly outstanding and a testament to its potential as a transformative treatment that can change the treatment paradigm for patients suffering from depression,” said Amir Inamdar, MBBS, DNB (Psych), FFPM, Chief Medical Officer of Cybin. “In our Phase 2 study of CYB003 in MDD, we reported remarkable efficacy results at 12 months, showing a
“In addition to our CYB003 program, Cybin is advancing our deuterated DMT program, CYB004, which is currently in a Phase 2 Generalized Anxiety Disorder (“GAD”) study,” said Geoff Varty, Ph.D., Senior Vice President of Research & Preclinical Development. “The data presented at this conference are foundational to our CYB004 program, as it provides proof-of-concept for deuterated DMT’s potential in the treatment of GAD.”
Poster 1 Details:
- Title: CYB003 Produces Robust and Enduring Antidepressant Effects in Patients with Major Depressive Disorder (MDD)
- Authors: Amir Inamdar, Sebastian Krempien, Alex Kelman, Atul Mahableshwarkar, Magdy Shenouda, Kimball Johnson, Saundra Ann Maass-Robinson, Pradip Pathare, Allison House-Gecewicz, Angela Sorie, Aaron Bartlone, Geoffrey Varty
- Poster Number: M77
Poster 2 Details:
- Title: SPL026 (DMT fumarate) in combination with Selective Serotonin Reuptake Inhibitors (SSRIs) for patients with Major Depressive Disorder
- Authors: Ellen H. James, Zelah Joel, Victoria Attwooll, Tiffanie A. Benway, Meghan H. Good, George Tziras, Carol Routledge, Thomas A. Macek
- Poster Number: M59
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 analog, in Phase 3 studies for the adjunctive treatment of Major Depressive Disorder and CYB004, a proprietary deuterated N,N-dimethyltryptamine molecule 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
Cautionary Notes and Forward-Looking Statements
Certain statements in this news release relating to the Company are forward-looking statements and are prospective in nature. Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “may”, “should”, “could”, “potential”, “possible”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe” or “continue”, or the negative thereof or similar variations. Forward-looking statements in this news release include statements regarding the Company’s potential viability for treatment for patients with MDD; the potential of CYB003 to change the course of disease; enhanced efficacy effect when SPL026 was administered with SSRIs; and the Company’s plans to engineer proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health conditions.
These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; implications of disease outbreaks on the Company's operations; and the risk factors set out in each of the Company's management's discussion and analysis for the three and six month ended September 30, 2024 and the Company’s annual information form for the year ended March 31, 2024, which are available under the Company's profile on SEDAR+ at www.sedarplus.ca and with the
Cybin makes no medical, treatment or health benefit claims about Cybin’s proposed products. The
Neither Cboe Canada, nor the NYSE American LLC stock exchange have approved or disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein.
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Investor & Media Contact:
Gabriel Fahel
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Cybin Inc.
1-866-292-4601
irteam@cybin.com – or – media@cybin.com
Source: Cybin Inc.
FAQ
What were the 12-month efficacy results for Cybin's (CYBN) CYB003 Phase 2 study in MDD?
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