Algernon NeuroScience Appoints Globally Recognized DMT Researcher and Clinician Dr. Sándor Nardai as Principal Investigator for Planned Phase 2a DMT Human Stroke Study
Algernon NeuroScience has appointed Dr. Sándor Nardai as Principal Investigator for its upcoming Phase 2a DMT stroke study in Europe. The study, involving 40 stroke patients, will be randomized, double-blind, and placebo-controlled, with enrollment expected to begin in Q3 2025.
Dr. Nardai, a leading stroke expert and Head of Neurointervention at Semmelweis University Center in Budapest, previously led a groundbreaking rat stroke study published in 2020. The study demonstrated that rats treated with sub-psychedelic DMT doses showed almost full motor function recovery and smaller infarct volumes compared to the control group, with statistically significant results.
The Phase 2a study's primary endpoint will focus on safety, with secondary endpoints including lesion volume, biomarkers, motor function, cognitive function, depression, and mortality.
Algernon NeuroScience ha nominato il Dr. Sándor Nardai come Investigatore Principale per il suo prossimo studio sul DMT per ictus di Fase 2a in Europa. Lo studio, che coinvolgerà 40 pazienti colpiti da ictus, sarà randomizzato, in doppio cieco e controllato con placebo, con l'arruolamento previsto per l'inizio del terzo trimestre del 2025.
Il Dr. Nardai, esperto di ictus di primo piano e Responsabile della Neurointervento presso il Centro Universitario Semmelweis di Budapest, ha precedentemente guidato uno studio innovativo sugli ictus nei ratti pubblicato nel 2020. Lo studio ha dimostrato che i ratti trattati con dosi di DMT sub-psichedeliche hanno mostrato un quasi completo recupero della funzione motoria e volumi di infarto più piccoli rispetto al gruppo di controllo, con risultati statisticamente significativi.
Il principale endpoint dello studio di Fase 2a si concentrerà sulla sicurezza, con endpoint secondari che includeranno il volume delle lesioni, i biomarcatori, la funzione motoria, la funzione cognitiva, la depressione e la mortalità.
Algernon NeuroScience ha nombrado al Dr. Sándor Nardai como Investigador Principal para su próximo estudio de DMT para accidente cerebrovascular en Fase 2a en Europa. El estudio, que involucrará a 40 pacientes con accidente cerebrovascular, será aleatorizado, doble ciego y controlado con placebo, con la inscripción prevista para comenzar en el tercer trimestre de 2025.
El Dr. Nardai, un experto líder en accidentes cerebrovasculares y Jefe de Neurointervención en el Centro Universitario Semmelweis en Budapest, previamente dirigió un estudio innovador sobre accidentes cerebrovasculares en ratas publicado en 2020. El estudio demostró que las ratas tratadas con dosis de DMT sub-psicodélicas mostraron casi una recuperación completa de la función motora y volúmenes de infarto más pequeños en comparación con el grupo de control, con resultados estadísticamente significativos.
El objetivo principal del estudio de Fase 2a se centrará en la seguridad, mientras que los objetivos secundarios incluirán el volumen de lesiones, biomarcadores, función motora, función cognitiva, depresión y mortalidad.
Algernon NeuroScience는 Dr. Sándor Nardai를 유럽에서 진행될 DMT 뇌졸중 연구의 주요 연구자로 임명했습니다. 이 연구는 40명의 뇌졸중 환자를 대상으로 진행되며, 무작위 이중 맹검 및 위약 대조 시험으로 이루어지며, 등록은 2025년 3분기부터 시작될 예정입니다.
뇌졸중 전문의이자 부다페스트의 세멜바이스대학교 신경중재학과 책임자인 Nardai 박사는 2020년에 발표된 획기적인 쥐 뇌졸중 연구를 이끌었습니다. 이 연구는 수-환각적 DMT 용량으로 치료받은 쥐가 대조군에 비해 거의 완전한 운동 기능 회복을 보였고, 더 작은 경색량을 나타냈으며, 통계적으로 유의미한 결과를 보여주었습니다.
2a상 연구의 주요 목표는 안전성에 초점을 맞추며, 부차적인 목표로는 병변 부피, 바이오마커, 운동 기능, 인지 기능, 우울증 및 사망률이 포함됩니다.
Algernon NeuroScience a désigné le Dr Sándor Nardai en tant qu'investigateur principal pour son étude DMT sur les AVC en phase 2a en Europe. L'étude, qui impliquera 40 patients ayant subi un AVC, sera randomisée, en double aveugle et contrôlée par placebo, avec un recrutement prévu pour le troisième trimestre 2025.
Le Dr Nardai, expert en AVC de premier plan et responsable de la neurointervention au Centre universitaire Semmelweis de Budapest, a précédemment dirigé une étude révolutionnaire sur les AVC chez les rats, publiée en 2020. L'étude a démontré que les rats traités par des doses de DMT sous-psychédéliques avaient montré presque une récupération complète de la fonction motrice et des volumes d'infarctus plus petits par rapport au groupe contrôle, avec des résultats statistiquement significatifs.
Le principal critère de l'étude de phase 2a se concentrera sur la sécurité, avec des critères secondaires comprenant le volume des lésions, les biomarqueurs, la fonction motrice, la fonction cognitive, la dépression et la mortalité.
Algernon NeuroScience hat Dr. Sándor Nardai zum Hauptinvestigator für die bevorstehende Phase-2a-DMT-Studie zur Schlaganfallbehandlung in Europa ernannt. Die Studie, die 40 Schlaganfallpatienten betrifft, wird randomisiert, doppelblind und placebokontrolliert sein, wobei die Einschreibung voraussichtlich im dritten Quartal 2025 beginnen wird.
Dr. Nardai, ein führender Schlaganfallexperte und Leiter der Neurointervention am Semmelweis-Universitätsklinikum in Budapest, leitete zuvor eine bahnbrechende Rattenstudie zu Schlaganfällen, die 2020 veröffentlicht wurde. Die Studie zeigte, dass Ratten, die mit sub-psychodelischen DMT-Dosen behandelt wurden, fast vollständige Wiederherstellung der motorischen Funktion und kleinere Infarktvolumina im Vergleich zur Kontrollgruppe zeigten, mit statistisch signifikanten Ergebnissen.
Der primäre Endpunkt der Phase-2a-Studie wird sich auf die Sicherheit konzentrieren, während sekundäre Endpunkte das Läsionsvolumen, Biomarker, motorische Funktion, kognitive Funktion, Depression und Mortalität umfassen.
- Appointment of experienced Principal Investigator with proven DMT research background
- Previous preclinical study showed statistically significant positive results in DMT treatment for stroke
- Phase 2a study planned to commence in Q3 2025 with comprehensive endpoints
- Study not starting until Q3 2025, indicating a significant waiting period
- sample size of 40 patients for the Phase 2a study
VANCOUVER, British Columbia, Feb. 11, 2025 (GLOBE NEWSWIRE) -- Algernon Pharmaceuticals Inc. (the “Company” or “AGN Pharma”) (CSE: AGN) (FRANKFURT: AGW0) (OTCQB: AGNPF), a Canadian clinical stage pharmaceutical development company, is pleased to announce that its wholly owned subsidiary, Algernon NeuroScience (AGN Neuro), has appointed Dr. Sándor Nardai as the Principal Investigator (PI) for its upcoming randomized, double-blind, placebo-controlled Phase 2a DMT study of 40 stroke patients in Europe. The study is expected to begin enrolling patients in Q3 of 2025.
Sándor Nardai MD PhD MBA, one of Europe’s leading stroke experts, is a cerebrovascular disease specialist with completed training and licences to practice interventional cardiology, neurology and neurointerventions. He is associate professor and the Head of the Department of Neurointervention at the Semmelweis University Center of Neurosurgery and Neurointervention in Budapest, Hungary – the country’s largest primary stroke center, serving a population of 3.5 million people.
Dr. Nardai is also the lead scientist who conducted the groundbreaking rat stroke occlusion study, published in Experimental Neurology in May 2020, showing that rats treated with a sub-psychedelic dose of DMT recovered almost full motor function and exhibited smaller infarct volumes (area of injury/damage) when compared to control group animals that did not receive DMT. Key data from the study achieved statistical significance.
“I was very pleased when I learned about Algernon’s commitment to investigate DMT a few years ago,” said Dr. Nardai. “While the primary endpoint of the planned Phase 2a study will be safety, stroke clinicians from around the world will be also be watching to see if DMT shows any positive signals with the secondary endpoints of lesion volume and other biomarkers, motor function, cognitive function, depression, and mortality.”
“We are very grateful to Dr. Nardai for his personal commitment in the pre-clinical investigation of DMT as a potential frontline treatment for stroke patients, appreciate his agreement to act as PI, and look forward to working with him as he leads the AGN Neuro phase 2a DMT stroke study,” said Christopher J. Moreau, CEO of AGN Pharma.
About DMT
N,N-Dimethyltryptamine, or DMT, is a hallucinogenic tryptamine drug producing effects similar to those of other psychedelics like LSD, ketamine, psilocybin and psilocin. DMT occurs naturally in many plant species and animals including humans and has been used in religious ceremonies as a traditional spiritual medicine by indigenous people in the Amazon basin. DMT can also be synthesised in a laboratory.
DMT is an agonist of multiple receptors, including serotonin receptors and the sigma-1 receptor. Sigma-1 is a multi-faceted stress-responsive receptor which promotes cell survival, neuroprotection, neuroplasticity, and neuroimmunomodulation. Further, DMT promotes the release of Brain-Derived Neurotrophic Factor (BDNF), a protein which can aid in recovery after a brain injury.
DMT has a rapid onset, intense psychedelic effects, and a relatively short duration of action at high doses. At sub-hallucinogenic doses, DMT has been shown to induce and improve structural and functional neuroplasticity both in vitro and in vivo murine models.
Algernon has filed patents for DMT pamoate and nicotinate (novel salt forms of DMT), in addition to formulation, dosage and method of use claims for ischemic stroke and TBI. The Company has also filed claims for combination therapy of DMT and stroke rehabilitation including constraint-induced movement therapy.
About Algernon NeuroScience
Algernon NeuroScience is a
For more information visit www.algernonneuroscience.com.
About Algernon Pharmaceuticals Inc.
Algernon Pharmaceuticals is a Canadian clinical stage pharmaceutical development company investigating multiple drugs for unmet global medical needs. Algernon Pharmaceuticals is also the parent company of a private subsidiary called Algernon NeuroScience, that is advancing a psychedelic program investigating a proprietary form of sub-psychedelic DMT for stroke and traumatic brain injury.
For more information visit www.algernonpharmaceuticals.com.
CONTACT INFORMATION
Christopher J. Moreau
CEO
Algernon Pharmaceuticals Inc.
604.398.4175 ext 701
info@algernonpharmaceuticals.com
investors@algernonpharmaceuticals.com
www.algernonpharmaceuticals.com.
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