atai Life Sciences Announces First Patient Dosed in Elumina, the Phase 2 Clinical Trial of VLS-01 for Treatment-Resistant Depression
atai Life Sciences (NASDAQ: ATAI) has initiated the Phase 2 Elumina clinical trial for VLS-01, announcing the first patient dosing. VLS-01, a proprietary oral transmucosal film formulation of DMT, is being developed to treat treatment-resistant depression (TRD) affecting approximately 100 million people globally.
The Elumina trial is a multicenter, double-blind, randomized, placebo-controlled study involving about 142 patients. The trial structure includes two treatment periods: First period participants will be randomized 1:1 to receive either 120mg VLS-01 or placebo on Day 1 and Week 2. The primary endpoint measures changes in Montgomery-Asberg Depression Rating Scale (MADRS) total score at Week 4, with final assessments at Week 14. The second period begins at Week 14, testing two different dose levels (60mg vs 120mg) of VLS-01.
The company expects to report topline results in Q1 2026. VLS-01 is designed to fit within the established two-hour interventional psychiatry treatment paradigm, aiming to provide rapid, robust, and durable antidepressant effects.
atai Life Sciences (NASDAQ: ATAI) ha avviato il trial clinico di Fase 2 Elumina per VLS-01, annunciando la somministrazione al primo paziente. VLS-01, una formulazione proprietaria di film transmucoso orale di DMT, è in fase di sviluppo per trattare la depressione resistente al trattamento (TRD) che colpisce circa 100 milioni di persone a livello globale.
Il trial Elumina è uno studio multicentrico, in doppio cieco, randomizzato e controllato con placebo che coinvolge circa 142 pazienti. La struttura dello studio prevede due periodi di trattamento: i partecipanti del primo periodo saranno randomizzati 1:1 per ricevere o 120mg di VLS-01 o un placebo il Giorno 1 e alla Settimana 2. L'obiettivo primario misura le variazioni nel punteggio totale della Montgomery-Asberg Depression Rating Scale (MADRS) alla Settimana 4, con valutazioni finali alla Settimana 14. Il secondo periodo inizia alla Settimana 14, testando due diversi livelli di dose (60mg vs 120mg) di VLS-01.
L'azienda prevede di riportare i risultati preliminari nel Q1 2026. VLS-01 è progettato per rientrare nel paradigma di trattamento psichiatrico interventistico stabilito di due ore, mirando a fornire effetti antidepressivi rapidi, robusti e duraturi.
atai Life Sciences (NASDAQ: ATAI) ha iniciado el ensayo clínico de Fase 2 Elumina para VLS-01, anunciando la dosificación del primer paciente. VLS-01, una formulación de película transmucosa oral de DMT, se está desarrollando para tratar la depresión resistente al tratamiento (TRD) que afecta a aproximadamente 100 millones de personas en todo el mundo.
El ensayo Elumina es un estudio multicéntrico, doble ciego, aleatorizado y controlado con placebo que involucra a aproximadamente 142 pacientes. La estructura del ensayo incluye dos períodos de tratamiento: los participantes del primer período serán aleatorizados 1:1 para recibir 120mg de VLS-01 o un placebo en el Día 1 y la Semana 2. El objetivo primario mide los cambios en la puntuación total de la Escala de Calificación de Depresión de Montgomery-Asberg (MADRS) en la Semana 4, con evaluaciones finales en la Semana 14. El segundo período comienza en la Semana 14, probando dos niveles de dosis diferentes (60mg vs 120mg) de VLS-01.
La empresa espera informar los resultados preliminares en el Q1 de 2026. VLS-01 está diseñado para encajar dentro del paradigma establecido de tratamiento psiquiátrico intervencionista de dos horas, con el objetivo de proporcionar efectos antidepresivos rápidos, robustos y duraderos.
atai Life Sciences (NASDAQ: ATAI)는 VLS-01에 대한 2상 Elumina 임상 시험을 시작하며 첫 번째 환자 투약을 발표했습니다. VLS-01은 DMT의 독점적인 경구 점막 투여 필름 제형으로, 약 1억 명의 전 세계적인 치료 저항성 우울증 (TRD)을 치료하기 위해 개발되고 있습니다.
Elumina 시험은 약 142명의 환자가 참여하는 다기관, 이중 맹검, 무작위, 위약 대조 연구입니다. 시험 구조는 두 개의 치료 기간을 포함합니다: 첫 번째 기간의 참가자는 1:1로 무작위 배정되어 1일차와 2주차에 120mg VLS-01 또는 위약을 받습니다. 주요 목표는 4주차에 Montgomery-Asberg 우울증 평가 척도(MADRS) 총 점수의 변화를 측정하며, 최종 평가는 14주차에 이루어집니다. 두 번째 기간은 14주차에 시작되며, VLS-01의 두 가지 다른 용량 수준(60mg vs 120mg)을 테스트합니다.
회사는 2026년 1분기에 주요 결과를 보고할 것으로 예상하고 있습니다. VLS-01은 2시간의 개입 정신의학 치료 패러다임 내에서 적합하도록 설계되어, 빠르고 강력하며 지속적인 항우울 효과를 제공하는 것을 목표로 하고 있습니다.
atai Life Sciences (NASDAQ: ATAI) a lancé l'essai clinique de Phase 2 Elumina pour VLS-01, annonçant la première administration au patient. VLS-01, une formulation de film transmucosal oral de DMT, est en cours de développement pour traiter la dépression résistante au traitement (TRD) touchant environ 100 millions de personnes dans le monde.
L'essai Elumina est une étude multicentrique, en double aveugle, randomisée et contrôlée contre placebo impliquant environ 142 patients. La structure de l'essai comprend deux périodes de traitement : les participants de la première période seront randomisés 1:1 pour recevoir soit 120 mg de VLS-01 soit un placebo le Jour 1 et la Semaine 2. Le critère principal mesure les changements dans le score total de l'échelle de notation de la dépression de Montgomery-Asberg (MADRS) à la Semaine 4, avec des évaluations finales à la Semaine 14. La deuxième période commence à la Semaine 14, testant deux niveaux de dose différents (60 mg contre 120 mg) de VLS-01.
L'entreprise s'attend à rapporter les résultats préliminaires au T1 2026. VLS-01 est conçu pour s'inscrire dans le paradigme établi de traitement psychiatrique interventionnel de deux heures, visant à fournir des effets antidépresseurs rapides, robustes et durables.
atai Life Sciences (NASDAQ: ATAI) hat die Phase-2-Elumina-Studie für VLS-01 gestartet und die erste Patientendosis angekündigt. VLS-01, eine proprietäre orale transmukosale Filmformulierung von DMT, wird entwickelt, um behandlungsresistente Depressionen (TRD) zu behandeln, die weltweit etwa 100 Millionen Menschen betreffen.
Die Elumina-Studie ist eine multizentrische, doppelblinde, randomisierte, placebo-kontrollierte Studie mit etwa 142 Patienten. Die Studienstruktur umfasst zwei Behandlungsperioden: Die Teilnehmer der ersten Periode werden im Verhältnis 1:1 randomisiert, um entweder 120 mg VLS-01 oder ein Placebo am Tag 1 und in Woche 2 zu erhalten. Der primäre Endpunkt misst die Veränderungen im Gesamtscore der Montgomery-Asberg Depression Rating Scale (MADRS) in Woche 4, mit abschließenden Bewertungen in Woche 14. Die zweite Periode beginnt in Woche 14 und testet zwei verschiedene Dosen (60 mg vs. 120 mg) von VLS-01.
Das Unternehmen erwartet, die Ergebnisse im ersten Quartal 2026 zu berichten. VLS-01 wurde entwickelt, um in das etablierte zweistündige paradigmatische Behandlungsschema der intervenierenden Psychiatrie zu passen, mit dem Ziel, schnelle, robuste und nachhaltige antidepressiven Effekte zu bieten.
- Large addressable market of 100 million TRD patients globally
- Trial design includes evaluation of durability with 12-week blinded data
- Innovative drug delivery system through proprietary oral transmucosal film
- Designed to fit within established 2-hour treatment paradigm
- Long timeline to topline results (Q1 2026)
- Requires multiple doses (Day 1, Week 2) which may impact treatment compliance
- Phase 2 trial success not guaranteed
Insights
atai Life Sciences has reached a significant clinical milestone by dosing the first patient in the Phase 2 Elumina trial for VLS-01, a proprietary buccal film formulation of DMT being developed for treatment-resistant depression (TRD).
The trial design is robust and comprehensive - a multicenter, double-blind, randomized, placebo-controlled study involving approximately 142 patients. This well-structured approach will evaluate both efficacy and durability of treatment effect with multiple doses administered over time. The trial includes two treatment periods, with the first providing 12 weeks of blinded durability data following two doses, and the second exploring response to different dose levels.
What's particularly notable is how VLS-01 is positioned to fit within the established two-hour interventional psychiatry paradigm, potentially offering a more practical implementation path than longer-acting psychedelic treatments. For TRD, which affects approximately 100 million people globally, this could represent a significant advancement if successful.
The primary endpoint measuring change in MADRS score at Week 4 is standard for depression trials, but the extended 14-week assessment period will provide important data on durability - a key differentiator for novel antidepressants. With topline results expected in Q1 2026, this represents an important catalyst in atai's development pipeline and advances their mission to transform mental health treatment.
The advancement of VLS-01 to Phase 2 clinical trials represents a potentially important development for treatment-resistant depression, a condition with profound unmet medical need affecting approximately 100 million people globally.
VLS-01's mechanism - utilizing DMT delivered via buccal film - is particularly interesting from a clinical implementation perspective. The two-hour interventional psychiatry framework mentioned aligns with existing treatment infrastructure, potentially enabling easier integration into clinical practice compared to longer-duration psychedelic sessions. This practical consideration is important for widespread adoption.
The trial design merits attention: administering doses at baseline and Week 2, with assessment through Week 14, will provide critical insights into both immediate efficacy and sustained effects. The Montgomery-Asberg Depression Rating Scale (MADRS) is the gold standard assessment tool, and improvement at the Week 4 primary endpoint would be clinically meaningful.
The second treatment period exploring different dose levels (60mg vs 120mg) adds valuable dose-response data. For context, the field of rapid-acting antidepressants has evolved substantially since ketamine showed efficacy for TRD, but challenges remain in balancing immediate effects with durability, side effect profiles, and practical administration. VLS-01 appears designed to address these challenges through its formulation approach and clinical protocol.
If successful, this would represent a significant advancement for patients who fail to respond to conventional treatments, offering a potential new option with a novel mechanism of action.
- Elumina is a Phase 2, multicenter, double-blind, randomized, placebo-controlled, clinical trial to assess the efficacy, safety and tolerability of VLS-01 (buccal film DMT) in people suffering from treatment-resistant depression
- VLS-01 is being developed as a rapid-acting, robust and durable antidepressant for people suffering from treatment-resistant depression, which affects approximately 100 million people globally
- VLS-01 is designed to fit within the established two-hour interventional psychiatry treatment paradigm
- Topline results from the Phase 2 Elumina trial are anticipated in the first quarter of 2026
NEW YORK and BERLIN, March 11, 2025 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai” or “Company”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced that the first patient has been dosed in the Phase 2 Elumina trial of VLS-01, atai’s proprietary oral transmucosal film formulation of N,N-Dimethyltryptamine (DMT) applied to the buccal surface, in people suffering from treatment-resistant depression (TRD).
"Dosing the first patient in the Phase 2 Elumina trial of VLS-01 marks a significant milestone in our commitment to transforming the treatment landscape for mental health disorders," stated Kevin Craig, M.D., Chief Medical Officer of atai. "Millions worldwide struggle with treatment-resistant depression, often left with few or no viable options. With VLS-01, we see the potential to offer rapid, robust, and durable antidepressant effects that could provide meaningful relief where existing treatments fall short. This trial brings us one step closer to delivering a new and innovative solution to those people who need it most."
Elumina is a Phase 2, multi-center, double-blind, randomized, placebo-controlled, clinical trial to assess the efficacy, safety and tolerability of repeated doses of VLS-01 (NCT06524830). The trial consists of two treatment periods. In the first treatment period, approximately 142 patients will be randomized 1:1 to receive a 120mg dose of VLS-01 or placebo on Day 1, followed by a second dose of the same intervention at Week 2. The primary endpoint is the change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score at Week 4. The last double-blind assessment visit will be at Week 14. The first treatment period will provide 12 weeks of blinded durability data following two doses of VLS-01 administered in a placebo-controlled fashion. Topline results from the first treatment period are anticipated in the first quarter of 2026.
The second treatment period starts at Week 14 and will explore the response to two different dose levels of VLS-01. Patients will be randomized 1:1 to receive a third dose of either 60mg or 120mg of VLS-01. Final safety and efficacy assessment will be conducted two weeks after administration of the third dose.
About VLS-01 (buccal film DMT)
VLS-01 is a proprietary oral transmucosal film formulation of N,N-Dimethyltryptamine (DMT) applied to the buccal surface, being developed for the treatment of people suffering from treatment-resistant depression (TRD). Pharmacologically, VLS-01 is a partial to full agonist of the 5-HT1/2/6/7 receptors and is being developed to potentially offer rapid, robust, and durable efficacy with a favorable safety profile. VLS-01 is designed to fit within the established two-hour interventional psychiatry treatment paradigm, positioning it for integration into existing care models. atai is enrolling patients into Elumina, the Phase 2, multi-center, double-blind, randomized, placebo-controlled, trial to assess the efficacy, safety and tolerability of VLS-01 in people suffering from TRD. Topline results from the first treatment period of the Phase 2 Elumina trial are anticipated in the first quarter of 2026.
About atai Life Sciences
atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. The Company was founded in response to the significant unmet need and lack of innovation in the mental health treatment landscape. atai is dedicated to developing novel, evidence-based therapeutics to treat depression, anxiety and other mental health disorders. atai's vision is to heal mental health disorders so that everyone, everywhere can live a more fulfilled life. For more information, please visit www.atai.life.
Forward-looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “initiate,” “could,” “would,” “project,” “plan,” “potentially,” “preliminary,” “likely,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these words. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements relating to our business strategy and plans; and the potential, success, cost and timing of development of VLS-01 and related trials and studies.
Forward-looking statements are neither promises nor guarantees, but involve known and unknown risks and uncertainties that could cause actual results to differ materially from those projected, including, without limitation, the factors described in the section titled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 28, 2024, as such factors may be updated from time to time in atai's other filings with the SEC. atai disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by applicable law.
Contact Information
Investor Contact:
IR@atai.life
Media Contact:
PR@atai.life
FAQ
What is the primary endpoint of ATAI's Phase 2 Elumina trial for VLS-01?
How many patients will participate in ATAI's Phase 2 Elumina trial?
When will ATAI release topline results for the VLS-01 Phase 2 trial?
What is the dosing schedule for VLS-01 in ATAI's Phase 2 Elumina trial?
What condition is ATAI's VLS-01 targeting in the Phase 2 Elumina trial?
