N,N-dimethyltryptamine (AP-188) / Algernon Pharma - LARVOL DELTA

Safety, Pharmacokinetics, and Pharmacodynamics of a 6-h N,N-Dimethyltryptamine (DMT) Infusion in Healthy Volunteers: A Randomized, Double-Blind, Placebo-Controlled Trial. (PubMed, Clin Transl Sci) - P1 | "Together, DMT administered intravenously as a 30-s bolus followed by a 6-h infusion and reaching maximal exposures of approximately 35 ng/mL in healthy volunteers was safe and demonstrated rapidly occurring but mild psychedelic effects, providing the basis for future proof-of-mechanism studies in patient populations. Trial Registration: ClinicalTrial.gov identifier: NCT05559931."

Clinical • Journal • PK/PD data • Cardiovascular • CNS Disorders • Ischemic stroke

Algernon NeuroScience Engages Netcapital Securities for Planned Regulation A Financing (GlobeNewswire) - "Algernon Pharmaceuticals Inc...is pleased to announce that its wholly owned subsidiary Algernon NeuroScience (AGN Neuro), has appointed Netcapital Securities Inc...for its planned Regulation A (Reg A) offering. Netcapital plans to provide broker-dealer and administrative services, excluding underwriting and placement agent services, in connection with this offering...AGN Neuro has filed a Form 1-A with the U.S. Securities and Exchange Commission (SEC), though the offering has not yet been qualified or declared effective by the SEC. AGN Neuro intends to use proceeds from the offering to advance its R&D initiatives, including conducting a randomized, double-blind, placebo-controlled Phase 2a DMT study of 40 actual stroke patients in the third quarter of 2025 in Hungary."

Financing • New P2 trial • Ischemic stroke

Algernon NeuroScience Appoints Globally Recognized DMT Researcher and Clinician Dr. Sándor Nardai as Principal Investigator for Planned Phase 2a DMT Human Stroke Study (GlobeNewswire) - "Algernon Pharmaceuticals Inc...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."

New P2a trial • Ischemic stroke

Single and Repeat Doses of DMT in Healthy Subjects (clinicaltrials.gov) - P1 | N=60 | Active, not recruiting | Sponsor: Algernon Pharmaceuticals | Trial completion date: Mar 2024 ➔ Mar 2026 | Trial primary completion date: Mar 2024 ➔ Mar 2026

Trial completion date • Trial primary completion date • Cardiovascular • BDNF • PRL

Single and Repeat Doses of DMT in Healthy Subjects (clinicaltrials.gov) - P1 | N=60 | Active, not recruiting | Sponsor: Algernon Pharmaceuticals | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2023 ➔ Mar 2024 | Trial primary completion date: Dec 2023 ➔ Mar 2024

Enrollment closed • Trial completion date • Trial primary completion date • Cardiovascular • BDNF • PRL

Single and Repeat Doses of DMT in Healthy Subjects (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Algernon Pharmaceuticals | Trial completion date: Jun 2023 ➔ Dec 2023 | Trial primary completion date: May 2023 ➔ Dec 2023

Trial completion date • Trial primary completion date • Cardiovascular

Algernon NeuroScience Announces Successful Completion of Highest Planned Single Dose in DMT Phase 1 Trial; Accelerates Plans for Phase 2 Stroke and TBI Studies (GlobeNewswire) - "Algernon Pharmaceuticals Inc...is pleased to advise that its subsidiary Algernon NeuroScience (AGN Neuro), has successfully completed dosing of the third and planned final cohort in its escalating dose Phase 1 clinical study of an intravenous (IV) formulation of AP-188 ('N,N-Dimethyltryptamine' or 'DMT'). AGN Neuro is the world’s first company to investigate DMT for both the treatment of stroke and traumatic brain injury (TBI)....Based on the success of the highest tested dose, the second part of the study, which will be scheduled to begin at a later time, will include dosing subjects for 6 hours with repeated administrations over a two-week period. AGN Neuro has now established a single dose regimen which can now be used in its first Phase 2 study for stroke and TBI."

Trial status • CNS Disorders • Ischemic stroke